Clinical trial NCT02080273: Six Month Plaque and Gingivitis Study Using Colgate Total Toothpaste
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dental Plaque
Gingivitis
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
Collaborators: name: Mahidol University
First posted: 2014-03-06
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Dental Plaque Score
timeFrame: baseline
measure: Dental Plaque Score
timeFrame: 3 weeks post treatment use
measure: Dental Plaque Score
timeFrame: 3 months post treatment use
measure: Dental Plaque Score
timeFrame: 6 months post treatment use
measure: Gingivitis Scores
timeFrame: baseline
measure: Gingivitis Scores
timeFrame: 3 weeks post treatment use
measure: Gingivitis Scores
timeFrame: 3 months post treatment use
measure: Gingivitis Scores
timeFrame: 6 months post treatment use
Secondary outcomes:
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: Mahidol University
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Terdphong Triratana
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.