Six Month Plaque and Gingivitis Study Using Colgate Total Toothpaste

Gingivitis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02080273
• Other study ID #: CRO-2012-10-CT-BKK-YPZ
• Status: Completed
• Phase: Phase 4
• Start date: March 2013
• Est. completion date: November 2013

Study information

• Verified date: March 2014
• Source: Colgate Palmolive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Plaque
• Gingivitis

Intervention

Drug:
• Colgate Cavity Protection toothpaste
0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment.
• Colgate Total toothpaste
0.32% sodium fluoride (1450 ppm NaF) and 0.3% triclosan. Colgate Total toothpaste is the active comparator toothpaste
• Parodontax toothpaste
1400 ppm sodium fluoride (NaF), Parodontax toothpaste is the active comparator toothpaste

Locations

Country	Name	City	State
Thailand	Mahidol University	Ratchathewi	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Colgate Palmolive	Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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