The Clinical Investigation of Toothpaste as Compared to Toothpaste and Mouthwash in Reducing Plaque and Gingivitis: A Six-week Clinical Study in the US

Colgate-Palmolive

Status and phase: Completed; Phase 4

Conditions: Dental Plaque; Gingivitis

Treatments: Drug: Fluoride Mouthwash; Drug: Triclosan/fluoride toothpaste; Drug: stannous fluoride toothpaste; Drug: cetylpyridinium chloride Mouthwash; Drug: fluoride toothpaste

Study type: Interventional

Funder types: Industry

Identifiers

NCT02360995

CRO-2014-06-PLAGIN-CT-YPZ

Details and patient eligibility

About

The objective of this clinical research study is to evaluate clinical efficacy of Colgate Total Toothpaste as compared to Crest Pro-Health Toothpaste and Crest Pro-Health Mouthwash, and Crest Cavity Protection Toothpaste and Crest Fluoride Mouthwash in reducing gingivitis and dental plaque in adults in a six-week clinical study.

Enrollment: 129 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-week duration of the 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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129 participants in 3 patient groups, including a placebo group

Total 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

Control group

Placebo Comparator group

Description:

fluoride toothpaste +fluoride mouthwash

Treatment:

Drug: fluoride toothpaste

Drug: Fluoride Mouthwash