A Clinical Study to Assess the Gingivitis Effects of Various Dentifrices

NCT06140771 | Completed

• 1 other identifier: 2021080
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this learning clinical study is to assess the gingivitis effects of four different dentifrices over a 3-month period.

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Löe-Silness Gingivitis Evaluation

  Baseline

• Löe-Silness Gingivitis Evaluation

  1 Month

Study Arms (4)

0.76% Sodium Monofluorophosphate Dentifrice

SHAM COMPARATOR

Drug: 0.76% Sodium Monofluorophosphate Dentifrice

1.15% Sodium Monofluorophosphate Dentifrice

SHAM COMPARATOR

Drug: 1.15% Sodium Monofluorophosphate Dentifrice

Marketed 0.454% Stannous Fluoride Dentifrice

ACTIVE COMPARATOR

Drug: 0.454% Stannous Fluoride Dentifrice

0.454% Stannous Fluoride Dentifrice

ACTIVE COMPARATOR

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 Dentifrice

1.15% Sodium Monofluorophosphate Dentifrice DRUG

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

1.15% Sodium Monofluorophosphate Dentifrice

0.454% Stannous Fluoride Dentifrice DRUG

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

Marketed 0.454% Stannous Fluoride Dentifrice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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 16 gradable teeth;
• Have mild to moderate gingivitis with a range of 10% to 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 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.

Sponsors & Collaborators

• Procter and Gamble: lead

Study Sites (1)

UHRG

Whittier, California, 90602, United States

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; 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: November 14, 2023
• First Posted: November 20, 2023
• Study Start: October 20, 2021
• Primary Completion: February 6, 2022
• Study Completion: February 6, 2022
• Last Updated: November 20, 2023

Record last verified: 2023-11

Locations

US (1)