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Completed

NCT Number: NCT07210138

Clinical Investigation of PerioGard (Test) Regimen

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mahidol University

Ratchathewi, Bangkok, 10400, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PeriGuard regimen

Drug

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

Colgate Dental Cream regimen

Drug

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

Primary outcomes

  1. Measurement of Loe-Silness Gingival Index score

    Time frame: baseline, 1 week, 4 week and 3 month

    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.

  2. Measurement of Quigley-Hein Plaque Index score

    Time frame: baseline, 1 week, 4 week and 3 month

    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.

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study title

The Clinical Investigation of PerioGard (Test) Regimen Compared to Control Regimen in Reducing Plaque and Gingivitis - a Three-month Study in Thailand

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 7, 2025
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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