Oral Irritation Study of Two Experimental Mouthrinses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:
NCT01156376
First received: June 30, 2010
Last updated: June 16, 2015
Last verified: June 2015
  Purpose

This study is 25 days long. People participating in this study will be asked to brush their teeth two times a day. People will be assigned to a mouthwash and will rinse four times a day at the site for five days. A dentist or dental hygienist will look at the mouth, teeth, tongue and gums to make sure the mouthwash does not irritate the mouth. After Day 5 of the study, people will continue to brush two times a day and will return on Day 24 to have their mouth looked at again. People without irritation in their mouth will rinse 4 times a day at the clinical site. People will return to the clinical site the next day and have a final oral exam in which the dentist or dental hygienist will look at the mouth for irritation.


Condition Intervention
Oral Manifestations
Device: Potassium Oxalate without Fluoride
Device: Potassium Oxalate with Fluoride
Device: Active Comparator PO-116-A

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Official Title: Determination of the Oral Irritation and Sensitization Potential of Two Experimental Potassium Oxalate Containing Mouthrinses

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • Percentage of Participants With an Abnormal Condition by Anatomical Site at Screening [ Time Frame: Screening ] [ Designated as safety issue: Yes ]
    Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

  • Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Baseline/Pretreatment [ Time Frame: Day 1 - Baseline/Pretreatment ] [ Designated as safety issue: Yes ]
    Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

  • Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Post-treatment [ Time Frame: Day 1 - Post-treatment ] [ Designated as safety issue: Yes ]
    Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

  • Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 3 [ Time Frame: Day 3 ] [ Designated as safety issue: Yes ]
    Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

  • Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 5 [ Time Frame: Day 5 ] [ Designated as safety issue: Yes ]
    Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

  • Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Pretreatment [ Time Frame: Day 24 - Pretreatment ] [ Designated as safety issue: Yes ]
    Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

  • Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Post-treatment [ Time Frame: Day 24 - Post-treatment ] [ Designated as safety issue: Yes ]
    Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

  • Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 25 [ Time Frame: Day 25 ] [ Designated as safety issue: Yes ]
    Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

  • Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Screening [ Time Frame: Screening ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Labial Mucosa at Screening [ Time Frame: Screening ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Screening [ Time Frame: Screening ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Screening [ Time Frame: Screening ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Gingiva at Screening [ Time Frame: Screening ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Tongue at Screening [ Time Frame: Screening ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Screening [ Time Frame: Screening ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Screening [ Time Frame: Screening ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 - Baseline/Pretreatment [ Time Frame: Day 1 - Baseline/Pretreatment ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 - Baseline/Pretreatment [ Time Frame: Day 1 - Baseline/Pretreatment ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 - Baseline/Pretreatment [ Time Frame: Day 1 - Baseline/Pretreatment ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 - Baseline/Pretreatment [ Time Frame: Day 1 - Baseline/Pretreatment ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 - Baseline/Pretreatment [ Time Frame: Day 1 - Baseline/Pretreatment ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Tongue at Day 1 - Baseline/Pretreatment [ Time Frame: Day 1 - Baseline/Pretreatment ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 - Baseline/Pretreatment [ Time Frame: Day 1 - Baseline/Pretreatment ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 - Baseline/Pretreatment [ Time Frame: Day 1 - Baseline/Pretreatment ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 - Post-treatment [ Time Frame: Day 1 - Post-treatment ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 - Post-treatment [ Time Frame: Day 1 - Post-treatment ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 - Post-treatment [ Time Frame: Day 1 - Post-treatment ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 - Post-treatment [ Time Frame: Day 1 - Post-treatment ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 - Post-treatment [ Time Frame: Day 1 - Post-treatment ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Tongue at Day 1 - Post-treatment [ Time Frame: Day 1 - Post-treatment ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 - Post-treatment [ Time Frame: Day 1 - Post-treatment ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 - Post-treatment [ Time Frame: Day 1 - Post-treatment ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 3 [ Time Frame: Day 3 ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 3 [ Time Frame: Day 3 ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 3 [ Time Frame: Day 3 ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 3 [ Time Frame: Day 3 ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Gingiva at Day 3 [ Time Frame: Day 3 ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Tongue at Day 3 [ Time Frame: Day 3 ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 3 [ Time Frame: Day 3 ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 3 [ Time Frame: Day 3 ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 5 [ Time Frame: Day 5 ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 5 [ Time Frame: Day 5 ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 5 [ Time Frame: Day 5 ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 5 [ Time Frame: Day 5 ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Gingiva at Day 5 [ Time Frame: Day 5 ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Tongue at Day 5 [ Time Frame: Day 5 ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 5 [ Time Frame: Day 5 ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 5 [ Time Frame: Day 5 ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Pretreatment [ Time Frame: Day 24 - Pretreatment ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Pretreatment [ Time Frame: Day 24 - Pretreatment ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Pretreatment [ Time Frame: Day 24 - Pretreatment ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Pretreatment [ Time Frame: Day 24 - Pretreatment ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Pretreatment [ Time Frame: Day 24 - Pretreatment ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Pretreatment [ Time Frame: Day 24 - Pretreatment ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Pretreatment [ Time Frame: Day 24 - Pretreatment ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Pretreatment [ Time Frame: Day 24 - Pretreatment ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Post-treatment [ Time Frame: Day 24 - Post-treatment ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Post-treatment [ Time Frame: Day 24 - Post-treatment ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Post-treatment [ Time Frame: Day 24 - Post-treatment ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Post-treatment [ Time Frame: Day 24 - Post-treatment ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Post-treatment [ Time Frame: Day 24 - Post-treatment ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Post-treatment [ Time Frame: Day 24 - Post-treatment ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Post-treatment [ Time Frame: Day 24 - Post-treatment ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Post-treatment [ Time Frame: Day 24 - Post-treatment ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 25 [ Time Frame: Day 25 ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 25 [ Time Frame: Day 25 ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 25 [ Time Frame: Day 25 ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 25 [ Time Frame: Day 25 ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Gingiva at Day 25 [ Time Frame: Day 25 ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Tongue at Day 25 [ Time Frame: Day 25 ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 25 [ Time Frame: Day 25 ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

  • Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 25 [ Time Frame: Day 25 ] [ Designated as safety issue: Yes ]
    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).


Enrollment: 80
Study Start Date: June 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PO-019
Formula 12027-019 Mouthwash
Device: Potassium Oxalate without Fluoride
1.40% Potassium Oxalate Sensitive Mouthwash without fluoride - Rinse with 10ml for 60 seconds, four times daily successively at 1 hour intervals for five days
Other Name: Formula 12027-019
Experimental: PO-020
Formula 12027-020 Mouthwash
Device: Potassium Oxalate with Fluoride
1.40% Potassium Oxalate Sensitive Mouthwash with fluoride - Rinse with 20ml for 60 seconds, four times daily successively at 1 hour intervals for five days
Other Name: Formula 12027-020
Active Comparator: PO-116-A
Cool Mint Listerine
Device: Active Comparator PO-116-A
Rinse with comparator mouthwash 20ml for 30 seconds, four times daily successively at 1 hour intervals for five days
Other Name: Cool Mint Listerine

Detailed Description:

This is a randomized, observer-blind, single-center, supervised, controlled, parallel-designed study. Approximately 90 generally healthy adults meeting the necessary inclusion/exclusion criteria will be enrolled so that 78 subjects (26 per treatment group) would reasonably be expected to complete the study. Subjects will have their oral soft/hard tissues assessed at Screening (visit 1), Baseline (visit 2), and Days 3, 5, 24, and 25 (visits 4,6-8). During the first week of the study, subjects will be instructed to brush their teeth for one minute in their usual manner, twice daily using the provided standard fluoride toothpaste. Subjects will return for the Baseline exam and, upon qualification with entry criteria, will be assigned to one of three treatment groups. Qualified subjects will be instructed to return to the site for five consecutive days. Subjects will have four supervised rinses with their assigned mouth rinse for either 30 or 60 seconds using 10 ml or 20 ml, at subsequent one-hour intervals. During the 5 consecutive days of exposure to the assigned mouthrinse, subjects will brush their teeth using the provided fluoride-free toothpaste and soft-bristled toothbrush.

Subjects will then have an 18-day rest period (off treatment). During this time, subjects will follow their usual oral hygiene and dietary habits, using the standard fluoride toothpaste and soft toothbrush provided, and must refrain from using any unassigned oral care products. On the 19th day after completion of Day 5 (Day 24), subjects will return for an oral examination. If no pathology is present, subjects will be given a challenge treatment (four supervised rinses) and the final oral examination will be performed on Day 25.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males and females at least 18 years of age in good general and oral health without any known allergy to commercial dental products or cosmetics.
  • Evidence of a personally signed and dated informed consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial.
  • Willingness to use the assigned products according to instructions, availability for appointments, and likelihood of completing the clinical trial.
  • Willingness to refrain from using any breath freshener products (e.g., oral care strips, candy-type mints, sprays, chewing gums, throat lozenges, cough drops or mouthwashes), whitening products and smokeless tobacco products within one week prior to and for the duration of the study, in order to reduce alternate sources of potential irritation and sensitization.
  • A minimum of 20 natural teeth.
  • Absence of abnormal or severe fissured tongue, geographic tongue, or any obvious tongue abnormalities that may interfere with the assessment of oral irritation.
  • Adequate oral hygiene (i.e., brush teeth daily & exhibit no signs of oral neglect).
  • Absence of neglected dental health (i.e., gross calculus deposits or rampant caries based on visual examination), significant oral soft tissue pathology, systematically-related gingival enlargement or tissue damage due to ill-fitting appliances or restoration.
  • Absence of orthodontic bands, appliances, bridges, extensive large restorations or removable orthodontic appliances.

Exclusion Criteria:

  • Volunteers who report history or presence of kidney disorders or kidney stones, Crohn's Disease or other malabsorption syndromes.
  • History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthwashes.
  • Physical limitations or restrictions that might preclude use of normal oral hygiene procedures (i.e., toothbrushing, mouthrinsing, etc.).
  • History or current evidence of significant oral soft tissue pathology, excluding gingivitis, based on the dentist's visual examination and at the discretion of the investigator.
  • Those requiring antibiotic premedication prior to dental treatment.
  • Participation in a dental clinical trial involving oral care products within the past 30 days.
  • Visual evidence of Moderate/Advanced Periodontitis (ADA Type III, IV).
  • Women who are pregnant, nursing or plan to become pregnant during the course of the study.
  • Volunteers requiring treatment with Indinavir or loop diuretics (i.e., Furosemide).
  • Other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial result and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial
  • Any clinical history which in the opinion of the investigator could compromise the safety of the subject or the clinical parameters being assessed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156376

Locations
United States, Indiana
University Park Research Center (UPRC)
Fort Wayne, Indiana, United States, 46825
Sponsors and Collaborators
Johnson & Johnson Consumer and Personal Products Worldwide
Investigators
Study Director: Michael Lynch, DMD, PhD Johnson & Johnson Consumer and Personal Products Worldwide
  More Information

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT01156376     History of Changes
Other Study ID Numbers: KOXDHY0003
Study First Received: June 30, 2010
Results First Received: May 28, 2015
Last Updated: June 16, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Oral Manifestations
Mouth Diseases
Signs and Symptoms
Stomatognathic Diseases
Fluorides
Cariostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on July 27, 2015