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Antiplaque/Antigingivitis Efficacy of Essential Oil Mouthrinses in Six-Month Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02980497
First Posted: December 2, 2016
Last Update Posted: December 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Taubate
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide
  Purpose
The objective of this randomized, single-center, examiner-blind, controlled, parallel group, six-month clinical study is to compare the antiplaque/antigingivitis potential of a no-alcohol essential oil containing mouthrinse and an alcohol essential oil containing mouthrinse. A negative control group using only an ADA Accepted anticavity toothpaste will be included.

Condition Intervention
Plaque Gingivitis Gum Inflammation Bleeding Other: Listerine Zero Mouthwash (without alcohol) Other: Listerine Antiseptic Mouthwash (with alcohol)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Determination of the Antiplaque/Antigingivitis Efficacy of Essential Oil Containing Mouthrinses In a Six-Month Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Mean Modified Gingival Index (MGI) at 6 Months [ Time Frame: 6 Months ]
    Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae on all scoreable teeth on a 5-grade categorical scale of 0=normal to 4=severe inflammation.


Secondary Outcome Measures:
  • Mean Modified Gingival Index (MGI) at 1 Month [ Time Frame: 1 Month ]
    Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae on all scoreable teeth on a 5-grade categorical scale of 0=normal to 4=severe inflammation.

  • Mean Modified Gingival Index (MGI) at 3 Months [ Time Frame: 3 Months ]
    Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae on all scoreable teeth on a 5-grade categorical scale of 0=normal to 4=severe inflammation.

  • Mean Gingival Bleeding Index (BI) at 1 Month [ Time Frame: 1 Month ]
    Gingival bleeding was assessed at four gingival areas (distobuccal, mid-buccal, mid-lingual, and mesiolingual) around each tooth on a 3-grade categorical scale of 0=absence of bleeding after 30 seconds, 1=bleeding after 30 seconds, and 2=immediate bleeding.

  • Mean Gingival Bleeding Index (BI) at 3 Months [ Time Frame: 3 Months ]
    Gingival bleeding was assessed at four gingival areas (distobuccal, mid-buccal, mid-lingual, and mesiolingual) around each tooth on a 3-grade categorical scale of 0=absence of bleeding after 30 seconds, 1=bleeding after 30 seconds, and 2=immediate bleeding.

  • Mean Gingival Bleeding Index (BI) at 6 Months [ Time Frame: 6 Months ]
    Gingival bleeding was assessed at four gingival areas (distobuccal, mid-buccal, mid-lingual, and mesiolingual) around each tooth on a 3-grade categorical scale of 0=absence of bleeding after 30 seconds, 1=bleeding after 30 seconds, and 2=immediate bleeding.

  • Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 1 Month [ Time Frame: 1 Month ]
    Plaque area was scored on six surfaces (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) of all scorable teeth on a 6-grade categorical scale of 0=no plaque to 5=plaque covering 2/3 or more of the surface.

  • Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 3 Months [ Time Frame: 3 Months ]
    Plaque area was scored on six surfaces (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) of all scorable teeth on a 6-grade categorical scale of 0=no plaque to 5=plaque covering 2/3 or more of the surface.

  • Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 6 Months [ Time Frame: 6 Months ]
    Plaque area was scored on six surfaces (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) of all scorable teeth on a 6-grade categorical scale of 0=no plaque to 5=plaque covering 2/3 or more of the surface.


Enrollment: 370
Study Start Date: September 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Listerine Zero Mouthwash (without alcohol)
Brushing twice daily in the usual manner with an ADA-Accepted Fluoride Toothpaste (Colgate Cavity Protection) using a soft-bristled toothbrush and rinsing with 20 ml of Listerine Zero Mouthwash (without alcohol) for 30 seconds.
Other: Listerine Zero Mouthwash (without alcohol)
20 ml of rinse for 30 seconds, twice a day
Active Comparator: Listerine Antiseptic Mouthwash (with alcohol)
Brushing twice daily in the usual manner with an ADA-Accepted Fluoride Toothpaste (Colgate Cavity Protection) using a soft-bristled toothbrush and rinsing with 20 ml of Listerine Antiseptic Mouthwash (with alcohol) for 30 seconds.
Other: Listerine Antiseptic Mouthwash (with alcohol)
20 ml of rinse for 30 seconds, twice a day
No Intervention: Brush only
Brush only twice daily in the usual manner with an ADA-Accepted Fluoride Toothpaste (Colgate Cavity Protection) using a soft-bristled toothbrush.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Males and females 18 years of age or older, in good general and oral health, except gingivitis.
  2. Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment;
  3. 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.
  4. A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, or third molars will not be included in the tooth count.
  5. A mean gingival index ≥ 1.75 according to the Modified Gingival Index.
  6. A mean plaque index ≥ 1.95 according to the Turesky modification of the Quigley-Hein Plaque Index scored on six surfaces per tooth.
  7. Absence of significant oral soft tissue pathology, excluding plaque-induced gingivitis, based on a visual examination and at the discretion of the Investigator.
  8. Absence of moderate/advanced periodontitis based on a clinical examination (ADA Type III, IV).
  9. Absence of fixed or removable orthodontic appliance or removable partial dentures.

Exclusion Criteria:

  1. History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes and mouthrinses and red food dye.
  2. History of serious medical conditions that, at the discretion of the Investigator, will disqualify the subject.
  3. History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
  4. Antibiotic, anti-inflammatory or anticoagulant therapy during the study or within the 2 weeks prior to the baseline exam.
  5. Regular use of chemotherapeutic antiplaque/antigingivitis products such as triclosan, essential oil, cetylpyridinium chloride, or chlorhexidine containing mouthrinses within the 2 weeks prior to baseline.
  6. Current or history of alcohol or drug abuse.
  7. Self reported pregnancy or lactation (this is an exclusion criterion due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980497


Locations
Brazil
University of Taubate
Taubate, Sao Paulo, Brazil, 12020-270
Sponsors and Collaborators
Johnson & Johnson Consumer and Personal Products Worldwide
University of Taubate
Investigators
Principal Investigator: Jose Cortelli, Ph. D Universidade de Taubate
Study Chair: Sheila Cortelli, Ph.D Universidade de Taubate
  More Information

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT02980497     History of Changes
Other Study ID Numbers: FCLGBP0056
First Submitted: November 30, 2016
First Posted: December 2, 2016
Last Update Posted: December 2, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
mouthrinse
plaque
gingivitis
gum bleeding

Additional relevant MeSH terms:
Inflammation
Hemorrhage
Gingivitis
Pathologic Processes
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Ethanol
Anti-Infective Agents, Local
Listerine
Thymol
Eucalyptol
Sodium Fluoride
Menthol
Salicylates
Methyl salicylate
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Cariostatic Agents
Protective Agents
Antipruritics
Dermatologic Agents
Antifungal Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents