Six Month Plaque and Gingivitis Study Using Colgate Total Toothpaste

NCT02080273 | Completed Phase 4 Results

• 1 other identifier: CRO-2012-10-CT-BKK-YPZ
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Plaque; Gingivitis

Outcome Measures

Primary Outcomes (8)

• Dental Plaque Score

  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)

  baseline

• Dental Plaque Score

  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 weeks post treatment use

• Dental Plaque Score

  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 months post treatment use

• Dental Plaque Score

  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)

  6 months post treatment use

• Gingivitis Scores

  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)

  baseline

• Gingivitis Scores

  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)

  3 weeks post treatment use

• Gingivitis Scores

  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)

  3 months post treatment use

• Gingivitis Scores

  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 months post treatment use

Study Arms (3)

Colgate Cavity Protection toothpaste

PLACEBO COMPARATOR

Brush whole mouth 2x/day with Colgate Cavity Protection toothpaste. This study treatment is currently marketed/sold in Poland

Drug: Colgate Cavity Protection toothpaste

Colgate Total toothpaste

ACTIVE COMPARATOR

Brush whole mouth 2x/day with Colgate Total toothpaste . This study treatment is currently marketed/sold in Poland

Drug: Colgate Total toothpaste

Parodontax

ACTIVE COMPARATOR

Brush whole mouth 2x/day with Parodontax toothpaste. This study treatment is currently marketed/sold in Poland.

Drug: Parodontax toothpaste

Interventions

Colgate Cavity Protection toothpaste DRUG

0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment.

Colgate Cavity Protection toothpaste

Colgate Total toothpaste DRUG

0.32% sodium fluoride (1450 ppm NaF) and 0.3% triclosan. Colgate Total toothpaste is the active comparator toothpaste

Colgate Total toothpaste

Parodontax toothpaste DRUG

1400 ppm sodium fluoride (NaF), Parodontax toothpaste is the active comparator toothpaste

Parodontax

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Colgate Palmolive: lead
• Mahidol University: collaborator

Study Sites (1)

Mahidol University

Ratchathewi, Bangkok, 10400, Thailand

Location

Related Publications (1)

• Triratana T, Kraivaphan P, Amornchat C, Mateo LR, Morrison BM Jr, Dibart S, Zhang YP. Comparing three toothpastes in controlling plaque and gingivitis: A 6-month clinical study. Am J Dent. 2015 Apr;28(2):68-74.

  PMID: 26087570 DERIVED

MeSH Terms

Conditions

Dental Plaque; Gingivitis

Interventions

hydrated silica gel-based toothpaste

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Results Point of Contact

• Title: Maria Ryan
• Organization: Colgate Palmolive Company

maria_ryan@colpal.com

732-878-7766

Study Officials

• Terdphong Triratana

  Mahidol University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 6, 2014
• Study Start: March 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: May 20, 2019
• Results First Posted: May 20, 2019

Record last verified: 2014-03

Locations

TH (1)