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)

Colgate-Palmolive

Status and phase: Completed; Phase 4

Conditions: Dental Plaque; Gingivitis

Treatments: Drug: Cetylpyridinium chloride mouthwash; Drug: stannous fluoride toothpaste; Drug: Triclosan/fluoride toothpaste; Drug: fluoride only toothpaste; Drug: Fluoride only mouthwash

Study type: Interventional

Funder types: Industry

Identifiers

NCT02366689

CRO-2014-05-PG-6MCTCPG-ED

Details and patient eligibility

About

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.

Enrollment: 179 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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179 participants in 3 patient groups, including a placebo group

Toothpaste

Active Comparator group

Description:

Triclosan/fluoride toothpaste

Treatment:

Drug: Triclosan/fluoride toothpaste

Toothpaste + mouthwash

Active Comparator group

Description:

stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash

Treatment:

Drug: Cetylpyridinium chloride mouthwash

Drug: stannous fluoride toothpaste

Fluoride only Toothpaste + mouthwash

Placebo Comparator group

Description:

Fluoride only toothpaste + Fluoride only Mouthwash

Treatment:

Drug: Fluoride only mouthwash

Drug: fluoride only toothpaste