Clinical Study Comparing Dental Plaque and Gingivitis Reduction After Using One of Three Oral Hygiene Multi-component Regimens (Using of a Manual Toothbrush, a Toothpaste and a Mouthwash)

• ClinicalTrials.gov Identifier: NCT02366689
• Recruitment Status: Completed
• First Posted: February 19, 2015
• Results First Posted: March 30, 2016
• Last Update Posted: March 30, 2016
• Sponsor: Colgate Palmolive
• Information provided by (Responsible Party): Colgate Palmolive

Tracking Information

• First Submitted Date: February 6, 2015
• First Posted Date: February 19, 2015
• Results First Submitted Date: January 28, 2016
• Results First Posted Date: March 30, 2016
• Last Update Posted Date: March 30, 2016
• Study Start Date: June 2014
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 12, 2015)

• Dental Plaque Scores [ 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)
• Dental Plaque Scores [ Time Frame: 3 months ]
  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)
• Dental Plaque Scores [ Time Frame: 6 months ]
  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)
• 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)
• Gingivitis Scores [ Time Frame: 3 months ]
  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)
• Gingivitis Scores [ Time Frame: 6 months ]
  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)

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical Study Comparing Dental Plaque and Gingivitis Reduction After Using One of Three Oral Hygiene Multi-component Regimens (Using of a Manual Toothbrush, a Toothpaste and a Mouthwash)
• Official Title: Clinical Efficacy in Reducing Established Dental Plaque and Gingivitis of a Toothpaste Containing 0.3% Triclosan, 2% Copolymer / Sodium Fluoride and a Manual Toothbrush as Compared to an Oral Hygiene Multi-component Regimen Encompassing the Use of a Manual Toothbrush, a Toothpaste Containing Stannous Fluoride / Sodium Hexametaphosphate and a Mouthwash Containing 0.07% Cetylpyridinium Chloride
• Brief Summary: The objective of this clinical research study is to assess the efficacy of a commercially available triclosan/copolymer toothpaste compared to a commercially available oral hygiene multi-component regimen encompassing the use of a manual toothbrush, a toothpaste containing stannous fluoride / sodium hexametaphosphate and a mouthwash containing cetylpyridinium chloride relative to a negative control regimen in reducing established dental plaque and gingivitis over three and six months of assigned product use.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Dental Plaque
• Gingivitis

Intervention

• Drug: Triclosan/fluoride toothpaste
  Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration).
  Other Name: Total toothpaste
• Drug: stannous fluoride toothpaste
  Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).
  Other Name: Crest Pro-Health toothpaste
• Drug: fluoride only toothpaste
  Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.
  Other Name: Crest Cavity Protection toothpaste
• Drug: Cetylpyridinium chloride mouthwash
  Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds.
  Other Name: Crest Pro-Health Multi-Protection Mouthwash
• Drug: Fluoride only mouthwash
  Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds.
  Other Name: Crest Pro-Health For Me Breezy Mint mouthwash

Study Arms

• Active Comparator: Toothpaste
  Triclosan/fluoride toothpaste
  Intervention: Drug: Triclosan/fluoride toothpaste
• Active Comparator: Toothpaste + mouthwash
  stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
  Interventions:

  • Drug: stannous fluoride toothpaste
  • Drug: Cetylpyridinium chloride mouthwash
• Placebo Comparator: Fluoride only Toothpaste + mouthwash
  Fluoride only toothpaste + Fluoride only Mouthwash
  Interventions:

  • Drug: fluoride only toothpaste
  • Drug: Fluoride only mouthwash

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 12, 2015): 179
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 2014
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Male and female subjects, ages 18-70, inclusive.
2. Availability for the six-month duration of the 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. Use of antibiotics 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. Pregnant women or women who are breast feeding.
9. Dental prophylaxis received in the past two weeks prior to baseline examinations.
10. History of allergies to oral care/personal care consumer products or their ingredients.
11. On any prescription medicines that might interfere with the study outcome.
12. An existing medical condition which prohibits eating or drinking for periods up to 4 hours.
13. History of alcohol or drug abuse

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02366689
• Other Study ID Numbers: CRO-2014-05-PG-6MCTCPG-ED
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Colgate Palmolive
• Study Sponsor: Colgate Palmolive
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Colgate Palmolive
• Verification Date: February 2015