Clinical Investigation of PerioGard (Test) Regimen

NCT07210138 | Completed Phase 3 FDA Drug

• 1 other identifier: CRO-2025-05-GUM-RGM-THA-YPZ
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Measurement of Loe-Silness Gingival Index score

  Loe-Silness Gingival Index score from 0 to 3 will be assigned by the examining dentist to all scoreable surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole mouth mean score for each subject will be determined by adding the values given by the examining dentist to each scoreable surface and dividing that number by the total number of surfaces scored.

  baseline, 1 week, 4 week and 3 month

• Measurement of Quigley-Hein Plaque Index score

  First using a red dye solution to disclose the plaque, a Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole mouth score for each subject will be determined by adding the values given by the dental examiner to each scoreable surface and dividing that number by the total number of surfaces scored.

  baseline, 1 week, 4 week and 3 month

Study Arms (2)

Test regimen

EXPERIMENTAL

Test Regimen: toothpaste, mouthwash and toothbrush

Drug: PeriGuard regimen

Control regimen

ACTIVE COMPARATOR

Control regimen: toothpaste, mouthwash and toothbrush

Drug: Colgate Dental Cream regimen

Interventions

Colgate Dental Cream regimen DRUG

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

Control regimen

PeriGuard regimen DRUG

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

Test regimen

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Mahidol University

Ratchathewi, Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Terdphong Triratana, DDS

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: October 7, 2025
• Study Start: August 18, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 18, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)