Clinical Investigation of a Toothpaste Containing Stannous Fluoride as Compared to Colgate Fluoride Toothpaste (CP_Total)

Colgate-Palmolive

Status and phase

Completed

Phase 4

Conditions

Gingivitis

Treatments

Drug: Colgate Total SF

Drug: Colgate Cavity Protection toothpaste

Study type

Interventional

Funder types

Industry

Identifiers

NCT04033575

CRO-2019-03-PG-SNF-FL-BGS

Details and patient eligibility

About

The objective of this study is to evaluate the clinical efficacy of a toothpaste containing stannous fluoride as compared to Colgate Fluoride Toothpaste in reducing plaque and gingivitis - a three- month study.

Full description

This was a 6-month, randomized, single-center, parallel group, double-blinded, clinical research study to assess the clinical efficacy of two toothpastes containing stannous fluoride (SnHW and CPH) as compared to Regular Fluoride Toothpaste on the reduction of established dental plaque and gingivitis in adults.

Enrollment

88 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subjects, ages 18-70, inclusive.
Availability for the six-month duration ofthe clinical research study.
Good general health.
Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein °Plaque Index (Turesky Modification).
Signed Informed Consent Form.

Exclusion criteria

Presence of partial denture.
Presence of partial removable dentures.
Tumor(s) of the soft or hard tissues of the oral cavity.
Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
Five or more carious lesions requiring immediate restorative treatment.
Antibiotic use any time during the one month prior to entry into the study.
Participation in any other clinical study or test panel within the one month prior to entry into the study.
Dental prophylaxis during the past two weeks prior to baseline examinations.
History of allergies to oral care/personal care consumer products or their ingredients.
On any prescription medicines that might interfere with the study outcome.
An existing medical condition which prohibits eating or drinking for periods up to 4 hours.
History of alcohol or drug abuse.
Pregnant or lactating subjects.