The Clinical Efficacy of Three Oral Hygiene Regimens Using a Manual Toothbrush, Toothpaste and a Mouthwash in Controlling Dental Plaque and Gingivitis

Colgate-Palmolive

Status and phase: Completed; Phase 3

Conditions: Dental Plaque; Gingivitis

Treatments: Drug: stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash; Drug: triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash; Drug: fluoride toothpaste + fluoride Mouthwash

Study type: Interventional

Funder types: Industry

Identifiers

NCT02193165

CRO-2014-07-PG-REG-PR-BS

Details and patient eligibility

About

The objective of this clinical research study is to assess the efficacy of three oral hygiene multi-component regimens encompassing the use of a manual toothbrush, toothpaste and a mouthwash in controlling established dental plaque and gingivitis.

Enrollment: 120 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male and female subjects, ages 21-70, inclusive.
2. Availability for the six-week 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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120 participants in 3 patient groups, including a placebo group

Regimen 1

Active Comparator group

Description:

triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash

Treatment:

Drug: triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash

Regimen 2

Active Comparator group

Description:

stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash

Treatment:

Drug: stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash

Regimen 3 - Control group

Placebo Comparator group

Description:

fluoride toothpaste + fluoride Mouthwash

Treatment:

Drug: fluoride toothpaste + fluoride Mouthwash