Clinical Investigation of PerioGard (Test) Regimen

NCT ID: NCT07210138

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-18
• Study Completion Date: 2026-01-31

Brief Summary

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

Conditions

Gingivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Test regimen

Test Regimen: toothpaste, mouthwash and toothbrush

Group Type: EXPERIMENTAL

PeriGuard regimen

Intervention Type: DRUG

0.45% Stannous Fluoride Toothpaste, CPC-Zinc Fluoride Mouthwash, Gummy Toothbrush

Control regimen

Control regimen: toothpaste, mouthwash and toothbrush

Group Type: ACTIVE_COMPARATOR

Colgate Dental Cream regimen

Intervention Type: DRUG

Colgate Cavity Protection Toothpaste, Fluoride Mouthwash,Colgate Extra Clean Soft-Bristled Toothbrush

Interventions

PeriGuard regimen

0.45% Stannous Fluoride Toothpaste, CPC-Zinc Fluoride Mouthwash, Gummy Toothbrush

Intervention Type: DRUG

Colgate Dental Cream regimen

Colgate Cavity Protection Toothpaste, Fluoride Mouthwash,Colgate Extra Clean Soft-Bristled Toothbrush

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Colgate Palmolive

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Terdphong Triratana, DDS

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

Mahidol University

Ratchathewi, Bangkok, Thailand

Countries

Thailand

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id