Skip to main content
OpenTrials
Completed

NCT Number: NCT06140784

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

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 dentifrices, have on plaque and oral microbiome composition.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gingivitis Gingival Diseases Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

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 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 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;
  • 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.

Treatment and study plan

0.76% 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).

  3. Mean Turesky Modified Quigley-Hein Index

    Time frame: Baseline

    The Turesky Modified Quigley-Hein Index was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual and mesiolingual) to assess plaque on all gradable teeth. Whole mouth average plaque scores were calculated for each subject and tooth surfaces by totaling the scores and dividing by the number of gradable sites examined. the scoring criteria is below; (0) No Plaque; (1) Separate flecks of plaque at the cervical margin; (2) A thin, continuous band of plaque (up to 1 mm) at the cervical margin; (3) A band of plaque wider than 1 mm, but covering less than one third of the side of the crown of the tooth; (4) Plaque covering at least one third, but less than two thirds of the side of the crown of the tooth; (5) Plaque covering two thirds or more of the side of the crown of the tooth.

  4. Mean Turesky Modified Quigley-Hein Index

    Time frame: 1 Month

    The Turesky Modified Quigley-Hein Index was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual and mesiolingual) to assess plaque on all gradable teeth. Whole mouth average plaque scores were calculated for each subject and tooth surfaces by totaling the scores and dividing by the number of gradable sites examined. the scoring criteria is below; (0) No Plaque; (1) Separate flecks of plaque at the cervical margin; (2) A thin, continuous band of plaque (up to 1 mm) at the cervical margin; (3) A band of plaque wider than 1 mm, but covering less than one third of the side of the crown of the tooth; (4) Plaque covering at least one third, but less than two thirds of the side of the crown of the tooth; (5) Plaque covering two thirds or more of the side of the crown of the tooth.

  5. Mean Turesky Modified Quigley-Hein Index

    Time frame: 3 Months

    The Turesky Modified Quigley-Hein Index was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual and mesiolingual) to assess plaque on all gradable teeth. Whole mouth average plaque scores were calculated for each subject and tooth surfaces by totaling the scores and dividing by the number of gradable sites examined. the scoring criteria is below; (0) No Plaque; (1) Separate flecks of plaque at the cervical margin; (2) A thin, continuous band of plaque (up to 1 mm) at the cervical margin; (3) A band of plaque wider than 1 mm, but covering less than one third of the side of the crown of the tooth; (4) Plaque covering at least one third, but less than two thirds of the side of the crown of the tooth; (5) Plaque covering two thirds or more of the side of the crown of the tooth.

Sponsors and collaborators

Lead sponsor

Procter and Gamble

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 20, 2023
Registry last updated
Mar 1, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.