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Completed

NCT Number: NCT06140771

A Clinical Study to Assess the Gingivitis Effects of Various Dentifrices

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UHRG

Whittier, California, 90602, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;
  • 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.

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.

Treatment and study plan

0.76% Sodium Monofluorophosphate Dentifrice

Drug

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

1.15% Sodium Monofluorophosphate Dentifrice

Drug

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

0.454% Stannous Fluoride Dentifrice

Drug

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

Primary outcomes

  1. Löe-Silness Gingivitis Evaluation

    Time frame: 3 Months

    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).

Secondary outcomes

  1. Löe-Silness Gingivitis Evaluation

    Time frame: Baseline

    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).

  2. Löe-Silness Gingivitis Evaluation

    Time frame: 1 Month

    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).

Sponsors and collaborators

Lead sponsor

Procter and Gamble

Industry

Registry information

Official study title

A Three-Month Clinical Study to Assess the Gingivitis Effects of Various Dentifrices

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 20, 2023
Registry last updated
Nov 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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