Evaluate Dental Plaque Benefit of a Preventive Treatment Gel

Dental Plaque Clinical Trial

Official title:

A Clinical Study to Evaluate Anti-Plaque Benefit of a Gel in a Modified- 4 Day Plaque Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03546491
• Other study ID #: 2018009
• Status: Completed
• Phase: Phase 3
• Start date: May 8, 2018
• Est. completion date: June 22, 2018

Study information

• Verified date: August 2019
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to evaluate anti-plaque efficacy of a preventive treatment gel in a modified 4-day plaque model.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 22, 2018
• Est. primary completion date: June 22, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Provide written informed consent prior to participation and be given a signed copy of the informed consent form;

• Be 18 years of age or older;

• Agree not to participate in any other oral/dental product studies during the study;

• Agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed;

• Agree to refrain from the use of any non-study oral hygiene products (subjects who are regular flossers will be allowed to floss during acclimation and wash-out periods);

• Agree to use an oral hygiene product that contains stannous fluoride;

• Agree to refrain from any form of non-specified oral hygiene during the treatment period, including the use of products such as floss, toothpicks for plaque removal, and chewing gum;

• Agree to refrain from any oral hygiene, eating and drinking after 11:00 PM the evening before plaque measurements on Day 0 and Day 4 of the treatment periods;

• Agree to return for all scheduled visits and follow study procedures;

• Possess a minimum of 20 natural teeth with scorable facial and lingual surfaces, of which at least 4 are molars; and,

• Be in good general health, as determined by the Investigator/designee based on a review of the health history/update for participation in the study.

Exclusion Criteria:• Have a medical condition requiring pre-medication prior to dental procedures;

• Have taken antibiotics within 2 weeks of the acclimation period or anticipate taking antibiotics at any time during the study;

• Have a history of allergies or hypersensitivity to dyes or dentifrices that contain stannous fluoride;

• Have removable or orthodontic appliances which interfere with obtaining 20 gradable teeth;

• Have previously demonstrated an inability to comply with study visit requirements;

• Have rampant caries, open or untreated caries, severe gingivitis or advanced periodontitis requiring prompt treatment; or,

• Present with any disease or condition(s) that could be expected to interfere with examination procedures or the subject's safe completion of the study.

Related Conditions & MeSH terms

• Dental Plaque

Intervention

Drug:
• Preventive Gel
0.4% Stannous Fluoride
• Marketed Control
0.243% Sodium Fluoride

Locations

Country	Name	City	State
United States	Oral Health Science Center	Mason	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Turesky Modified Quigley-Hein Index at Day 4	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.	Day 4
Secondary	Mean Turesky Modified Quigley-Hein Index at 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.	Baseline
Secondary	Digital Plaque Imaging	Total percent dental plaque area	Day 4
Secondary	Overall Baseline Mean Digital Plaque Imaging	Total percent dental plaque area	Baseline