The Clinical of Stannous Fluoride Toothpaste and a Newly Designed Toothbrush Compared to Colgate Cavity Protection Toothpaste and a Regular Toothbrush in Reducing Plaque and Gingivitis.

NCT06427499 | Completed Phase 3 FDA Drug

• 1 other identifier: CRO-2024-04-PGN-BKS-YPZ
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

Qualified subjects will be enrolled and randomly assigned to either of the two study groups based on their initial Plaque and Gingivitis scores. During the first visit, subjects will undergo three key procedures: 1) evaluation for baseline plaque and gingivitis, 2) brushing with the assigned regimen products for two minutes, and 3) assessment for post-brushing plaque only. Subjects will be provided with clear instructions for regimen product usage and will be expected to adhere to these instructions. Follow-up evaluations for plaque and gingivitis will be conducted at one week, six weeks, and three months after initiation of regimen product use. Throughout the study period, continuous monitoring for adverse events will be carried out for all subjects.

Conditions

Plaque; Gingivitis

Outcome Measures

Primary Outcomes (2)

• Loe and Silness Gingival Index.

  A 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, one week, six weeks and three months

• Quigley and Hein Plaque Index

  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, one week, six weeks and three months

Study Arms (2)

Stannous Fluoride Toothpaste

EXPERIMENTAL

brush for 2 min, 2x/day, morning and night

Drug: Stannous fluoride toothpaste

Sodium monofluorophosphate toothpaste

ACTIVE COMPARATOR

brush for 2 min, 2x/day, morning and night

Drug: Colgate Cavity Protection Toothpaste

Interventions

Stannous fluoride toothpaste DRUG

brush 2 min morning \& night daily

Stannous Fluoride Toothpaste

Colgate Cavity Protection Toothpaste DRUG

brush 2 min morning \& night daily

Sodium monofluorophosphate toothpaste

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). 5. 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

Plaque, Amyloid; Gingivitis

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Terdphong Triratana

  M U International Oral Science Research, Ltd

  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: May 20, 2024
• First Posted: May 24, 2024
• Study Start: April 22, 2024
• Primary Completion: August 5, 2024
• Study Completion: August 5, 2024
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)