Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 11 of 292 for:    Sodium Fluoride OR Duraphat

Six Month Plaque and Gingivitis Study Using Colgate Total Toothpaste

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.
 
ClinicalTrials.gov Identifier: NCT02080273
Recruitment Status : Completed
First Posted : March 6, 2014
Results First Posted : May 20, 2019
Last Update Posted : May 20, 2019
Sponsor:
Collaborator:
Mahidol University
Information provided by (Responsible Party):
Colgate Palmolive

Brief Summary:
The objective of this randomized, single center, parallel clinical research study is to evaluate the comparative efficacy performance of three dentifrices -Colgate Total Toothpaste, Parodontax Toothpaste and Colgate Cavity Protection Toothpaste in controlling gingivitis and dental plaque in adults.

Condition or disease Intervention/treatment Phase
Dental Plaque Gingivitis Drug: Colgate Cavity Protection toothpaste Drug: Colgate Total toothpaste Drug: Parodontax toothpaste Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Clinical Investigation of Colgate Total Toothpaste as Compared to Parodontax Toothpaste and Colgate Cavity Protection Toothpaste in Controlling Established Plaque and Gingivitis. (A Six Month Study)
Study Start Date : March 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Colgate Cavity Protection toothpaste
Brush whole mouth 2x/day with Colgate Cavity Protection toothpaste. This study treatment is currently marketed/sold in Poland
Drug: Colgate Cavity Protection toothpaste
0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment.

Active Comparator: Colgate Total toothpaste
Brush whole mouth 2x/day with Colgate Total toothpaste . This study treatment is currently marketed/sold in Poland
Drug: Colgate Total toothpaste
0.32% sodium fluoride (1450 ppm NaF) and 0.3% triclosan. Colgate Total toothpaste is the active comparator toothpaste

Active Comparator: Parodontax
Brush whole mouth 2x/day with Parodontax toothpaste. This study treatment is currently marketed/sold in Poland.
Drug: Parodontax toothpaste
1400 ppm sodium fluoride (NaF), Parodontax toothpaste is the active comparator toothpaste




Primary Outcome Measures :
  1. Dental Plaque Score [ Time Frame: baseline ]
    Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)

  2. Dental Plaque Score [ Time Frame: 3 weeks post treatment use ]
    Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)

  3. Dental Plaque Score [ Time Frame: 3 months post treatment use ]
    Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)

  4. Dental Plaque Score [ Time Frame: 6 months post treatment use ]
    Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)

  5. Gingivitis Scores [ Time Frame: baseline ]
    Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)

  6. Gingivitis Scores [ Time Frame: 3 weeks post treatment use ]
    Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)

  7. Gingivitis Scores [ Time Frame: 3 months post treatment use ]
    Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)

  8. Gingivitis Scores [ Time Frame: 6 months post treatment use ]
    Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects, ages 18-70, inclusive.
  2. Availability for the six-month duration ofthe clinical research study.
  3. Good general health.
  4. Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
  5. Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
  6. Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
  7. Signed Informed Consent Form.

Exclusion Criteria:

  1. Presence of orthodontic bands.
  2. Presence of partial removable dentures.
  3. Tumor(s) of the soft or hard tissues of the oral cavity.
  4. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
  5. Five or more carious lesions requiring immediate restorative treatment.
  6. Antibiotic use any time during the one month prior to entry into the study.
  7. Participation in any other clinical study or test panel within the one month prior to entry into the study.
  8. Dental prophylaxis during the past two weeks prior to baseline examinations.
  9. History of allergies to oral care/personal care consumer products or their ingredients.
  10. On any prescription medicines that might interfere with the study outcome.
  11. An existing medical condition which prohibits eating or drinking for periods up to 4 hours.
  12. History of alcohol or drug abuse.
  13. Pregnant or lactating subjects.

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): NCT02080273


Locations
Layout table for location information
Thailand
Mahidol University
Ratchathewi, Bangkok, Thailand, 10400
Sponsors and Collaborators
Colgate Palmolive
Mahidol University
Investigators
Layout table for investigator information
Principal Investigator: Terdphong Triratana Mahidol University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT02080273     History of Changes
Other Study ID Numbers: CRO-2012-10-CT-BKK-YPZ
First Posted: March 6, 2014    Key Record Dates
Results First Posted: May 20, 2019
Last Update Posted: May 20, 2019
Last Verified: March 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Listerine
Sodium Fluoride
Gingivitis
Dental Plaque
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Dental Deposits
Tooth Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents