Clinical Study to Assess Therapeutic Delay and Resolution of Induced Gingivitis

Phase 4

Completed

• Conditions: Gingivitis
• Interventions: Drug: Stannous Fluoride Toothpaste; Drug: Colgate fluoride toothpaste

• Registration Number: NCT05731778
• Lead Sponsor: Colgate Palmolive

Brief Summary

Evaluate a stannous technology for its effect on the neutrophil phenotype during an induced gingivitis state.

Detailed Description

A 9-weeks clinical study will be conducted to evaluate a stannous fluoride dentifrice for therapeutic effects that aim to delay the onset of experimental gingivitis as well as hasten the resolution of disease.

Study Timeline

• Study Start: 2018-12-22
• Status Verified: 2019-04
• Study First Submitted: 2019-07-24
• Primary Completion: 2020-12-22
• Study Completion: 2020-12-22
• Study First Submitted QC: 2023-02-07
• Last Update Submitted: 2023-02-07
• Study First Posted: 2023-02-16
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1. Male or female volunteers aged 18-70 years
2. In good general health, ASA I
3. No clinical signs of gingival inflammation at >90% sites observed
4. Probing Depth (PD) < 3.0 mm
5. Attachment Loss (AL) = 0 mm
6. No periodontal disease history
7. Non-smokers
8. Fluent in English

Exclusion Criteria

1. Presence of orthodontic bands.
2. Presence of partial removal dentures.
3. Tumour(s) of the soft or the hard tissues of the oral cavity.
4. Cavitated carious lesions requiring immediate restorative treatment.
5. History of allergy to consumer or personal care products or dentifrice ingredients as determined by the dental profession monitoring the study.
6. Participation in any other clinical study or test panel with a one month period prior to entering the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stannous fluoride test toothpaste	Stannous Fluoride Toothpaste	Currently marketed as the new Colgate Total SF containing Stannous Fluoride
Colgate flouride toothpaste	Colgate fluoride toothpaste	Colgate Dental Cream containing Stannous Sodium Fluoride

Primary Outcome Measures

Name	Time	Method
Bleeding Index (BOP) and Oral Inflammatory Load	during patient visit over the 9 weeks	BOP is a bleeding index standard in field, oral inflammatory load as measured by neutrophil levels in oral rinses

Trial Locations

Locations (1)

University of Toronto; 🇨🇦 Toronto, Ontario, Canada