The Clinical Investigation of a New Toothpaste Containing Stannous Fluoride as Compared to a Commercially Available Fluoride Toothpaste in Reducing Plaque and Gingivitis

Colgate-Palmolive

Status and phase: Completed; Phase 3

Conditions: Dental Plaque; Gingivitis

Treatments: Drug: Stannous fluoride toothpaste; Drug: MFP Fluoride toothpaste

Study type: Interventional

Funder types: Industry

Identifiers

NCT03852056

CRO-2017-02-GIN-SNDZ-YPZ

Details and patient eligibility

About

The objective of this study is to evaluate the clinical efficacy of a new toothpaste containing stannous fluoride (SnF) as compared to Colgate Fluoride Toothpaste in reducing gingivitis and dental plaque.

Full description

This is a 6 month, take home, tooth brushing research study to evaluate a new toothpaste.

Qualified subjects will be enrolled and randomized to either one of the two study groups based on their initial Plaque and Gingivitis scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after three and six months of product use. All subjects will be followed for adverse events throughout the study.

Enrollment: 98 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 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 period 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 that prohibits eating or drinking for periods up to 4 hours.
12. History of alcohol or drug abuse.
13. Self-reported pregnant or lactating subjects.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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98 participants in 2 patient groups, including a placebo group

MFP Fluoride toothpaste

Placebo Comparator group

Description:

Commercially available, monofluorophosphate (MFP) toothpaste. Fluoride level is 0.76%

Treatment:

Drug: MFP Fluoride toothpaste

Stannous Fluoride Toothpaste

Experimental group

Description:

New toothpaste containing 0.454% stannous fluoride.

Treatment:

Drug: Stannous fluoride toothpaste