Six Month Plaque and Gingivitis Study Using Colgate Total Toothpaste

Colgate-Palmolive

Status and phase: Completed; Phase 4

Conditions: Dental Plaque; Gingivitis

Treatments: Drug: Colgate Total toothpaste; Drug: Parodontax toothpaste; Drug: Colgate Cavity Protection toothpaste

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02080273

CRO-2012-10-CT-BKK-YPZ

Details and patient eligibility

About

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.

Enrollment: 135 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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135 participants in 3 patient groups, including a placebo group

Colgate Cavity Protection toothpaste

Placebo Comparator group

Description:

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

Treatment:

Drug: Colgate Cavity Protection toothpaste

Colgate Total toothpaste

Active Comparator group

Description:

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

Treatment:

Drug: Colgate Total toothpaste

Parodontax

Active Comparator group

Description:

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

Treatment:

Drug: Parodontax toothpaste