Clinical Study to Assess Therapeutic Delay and Resolution of Induced Gingivitis

Gingivitis Clinical Trial

Official title:

Clinical Study to Assess Therapeutic Delay and Resolution of Induced Gingivitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05731778
• Other study ID #: CRO-2018-07-IND-GING-DELAY-JG
• Status: Completed
• Phase: Phase 4
• Start date: December 22, 2018
• Est. completion date: December 22, 2020

Study information

• Verified date: April 2019
• Source: Colgate Palmolive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 22, 2020
• Est. primary completion date: December 22, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingivitis

Intervention

Drug:
• Stannous Fluoride Toothpaste
0.454% stannous fluoride toothpaste
• Colgate fluoride toothpaste
0.76 % Sodium MonoFluorophosphate (MFP)

Locations

Country	Name	City	State
Canada	University of Toronto	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Colgate Palmolive

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding Index (BOP) and Oral Inflammatory Load	BOP is a bleeding index standard in field, oral inflammatory load as measured by neutrophil levels in oral rinses	during patient visit over the 9 weeks