Clinical Investigation of PerioGard (Test) Regimen

Colgate-Palmolive

Status and phase

Active, not recruiting

Phase 3

Conditions

Gingivitis

Treatments

Drug: Colgate Dental Cream regimen

Drug: PeriGuard regimen

Study type

Interventional

Funder types

Industry

Identifiers

NCT07210138

CRO-2025-05-GUM-RGM-THA-YPZ

Details and patient eligibility

About

The objective of this three-month clinical research study is to evaluate the clinical efficacy of the PerioGard (test) regimen (0.45% SnF-HW Toothpaste, CPC-Zinc-Fluoride Mouthwash, Gummy Toothbrush) compared to the control regimen (regular fluoride toothpaste, fluoride mouthwash, flat-trim toothbrush) in reducing gingivitis and dental plaque in adults

Enrollment

80 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subjects, ages 18-70, inclusive.
Availability for the three-month duration of the 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 orthodontic bands.
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 period 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 that prohibits eating or drinking for periods up to 4 hours.
History of alcohol or drug abuse.
Pregnant or lactating subjects.