A Clinical Study to Assess the Plaque and Gingivitis Effects of a Stannous Fluoride Dentifrice

Gingivitis Clinical Trial

Official title:

A 3-Month Clinical Study to Assess the Plaque and Gingivitis Effects of a Stannous Fluoride Dentifrice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03936569
• Other study ID #: 2018122
• Status: Completed
• Phase: Phase 4
• Start date: October 29, 2018
• Est. completion date: January 25, 2019

Study information

• Verified date: June 2023
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this clinical study is to assess the effects of a 0.454% stannous fluoride dentifrice on gingivitis and plaque after 3 months when compared to a negative control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 25, 2019
• Est. primary completion date: January 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Be at least 18 years of age;

• Provide written informed consent prior to participation and be given a signed copy of the informed consent form;

• Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;

• Have at least 16 gradable teeth;

• Agree to return for scheduled visits and follow the study procedures;

• Agree to refrain from use of any non-study oral hygiene products for the duration of the study;

• Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study.

Exclusion Criteria:

• Having taken antibiotic, anti-inflammatory, or anti-coagulant medications within 4 weeks of the Baseline Visit;

• Have any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease;

• Removable oral appliances;

• Fixed facial or lingual orthodontic appliances;

• Self-reported pregnancy or lactation;

• Any diseases or condition that might interfere with the safe participation in the study; and

• Inability to undergo study procedures.

Related Conditions & MeSH terms

• Gingivitis

Intervention

Drug:
• Marketed Toothpaste
Marketed stannous fluoride (0.454%) toothpaste
• Marketed Cavity Protection Toothpaste
Marketed sodium monofluorophosphate (0.76 %) toothpaste

Locations

Country	Name	City	State
United States	Silverstone Research Group	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Löe-Silness Gingivitis Evaluation	Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).	Baseline
Primary	Löe-Silness Gingivitis Evaluation	Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).	1 Month
Primary	Löe-Silness Gingivitis Evaluation	Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).	3 Months
Secondary	Turesky Modified Quigley-Hein Index	The Turesky Modified Quigley-Hein Index is a validated assessment of dental plaque based on a scale of 0 (no plaque/debris) to 5 (plaque covering two-thirds or more of the side of the crown or tooth).	Baseline
Secondary	Turesky Modified Quigley-Hein Index	The Turesky Modified Quigley-Hein Index is a validated assessment of dental plaque based on a scale of 0 (no plaque/debris) to 5 (plaque covering two-thirds or more of the side of the crown or tooth).	1 Month
Secondary	Turesky Modified Quigley-Hein Index	The Turesky Modified Quigley-Hein Index is a validated assessment of dental plaque based on a scale of 0 (no plaque/debris) to 5 (plaque covering two-thirds or more of the side of the crown or tooth).	3 Months