Status:

COMPLETED

A Clinical Study to Assess the Gingivitis and Plaque Effects of Various Dentifrices

Lead Sponsor:

Procter and Gamble

Conditions:

Gingivitis

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The primary objective of this study is to evaluate the effect four different dentifrices have on gingivitis after 12 weeks of product use. The secondary objectives are to assess the effect four dentif...

Eligibility Criteria

Inclusion

  • 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 at least 20 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;
  • Agree to refrain from any oral hygiene the morning of your visit
  • Agree to refrain from eating, drinking (except water), using tobacco, floss, use toothpicks, breath mints, or chew gum after performing your evening brushing.

Exclusion

  • 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;
  • Having had a dental prophylaxis within 2 weeks of plaque sampling visits;
  • 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.

Key Trial Info

Start Date :

September 2 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 10 2023

Estimated Enrollment :

116 Patients enrolled

Trial Details

Trial ID

NCT06140784

Start Date

September 2 2023

End Date

December 10 2023

Last Update

March 1 2024

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

UHRG

Whittier, California, United States, 90602

A Clinical Study to Assess the Gingivitis and Plaque Effects of Various Dentifrices | DecenTrialz