Brief Title: a Clinical Study to Assess Gingivitis

NCT06659471 | Completed

• 1 other identifier: 2021117
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this learning clinical study is to evaluate the effects of formulation chemistry on gingivitis.

Conditions

Gingival Diseases

Outcome Measures

Primary Outcomes (1)

• Number Bleeding Sites

  Number of bleeding sites derived from the Löe-Silness Gingivitis Evaluation based on 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, 1 month

Secondary Outcomes (1)

• Löe-Silness Gingivitis Evaluation

  3 months, 1 month

Study Arms (4)

0.76% Sodium Monofluorophosphate

SHAM COMPARATOR

0.76% Sodium Monofluorophosphate

Drug: 0.76% Sodium Monofluorophosphate Dentifrice

0.454% Stannous Fluoride

ACTIVE COMPARATOR

0.454% Stannous Fluoride

Drug: 0.454% Stannous Fluoride Dentifrice

0.454% Stannous Fluoride, 4.7 pH

EXPERIMENTAL

0.454% Stannous Fluoride, 4.7 pH

Drug: 0.454% Stannous Fluoride Dentifrice

0.454% Stannous Fluoride, 5.8 pH

EXPERIMENTAL

0.454% Stannous Fluoride, 5.8 pH

Drug: 0.454% Stannous Fluoride Dentifrice

Interventions

0.76% Sodium Monofluorophosphate Dentifrice DRUG

Whole mouth brushing with a toothpaste, twice daily for the duration of the study.

0.76% Sodium Monofluorophosphate

0.454% Stannous Fluoride Dentifrice DRUG

Whole mouth brushing with a toothpaste, twice daily for the duration of the study.

0.454% Stannous Fluoride; 0.454% Stannous Fluoride, 4.7 pH; 0.454% Stannous Fluoride, 5.8 pH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 20 gradable teeth;
• Have established gingivitis with 10-70 % bleeding sites;
• 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.

You may not qualify if:

• Having taken medications (antibiotic, anti-inflammatory, or anti-coagulant) which could alter gingival bleeding within 4 weeks of the Baseline Visit;
• Having 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;
• Having known hypersensitivity to the test products;
• Having removable oral appliances;
• Having fixed facial or lingual orthodontic appliances;
• Self-reported pregnancy or lactation;
• Having any diseases or condition that might interfere with the safe participation in the study;
• Having an inability to undergo study procedures.

Sponsors & Collaborators

• Procter and Gamble: lead

Study Sites (1)

Silverstone Research

Las Vegas, Nevada, 89146, United States

Location

MeSH Terms

Conditions

Gingival Diseases

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 26, 2024
• Study Start: March 7, 2022
• Primary Completion: June 6, 2022
• Study Completion: June 6, 2022
• Last Updated: October 26, 2024

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)