Evaluate Dental Plaque Benefit of a Preventive Treatment Gel

NCT03546491 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 2018009
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Plaque

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Mean Turesky Modified Quigley-Hein Index at Baseline

  Baseline

• Digital Plaque Imaging

  Day 4

• Overall Baseline Mean Digital Plaque Imaging

  Baseline

Study Arms (2)

Preventive Gel

EXPERIMENTAL

0.4% stannous fluoride

Drug: Preventive Gel

Marketed Control

ACTIVE COMPARATOR

0.243 % Sodium Fluoride

Drug: Marketed Control

Interventions

Preventive Gel DRUG

0.4% Stannous Fluoride

Preventive Gel

Marketed Control DRUG

0.243% Sodium Fluoride

Marketed Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Procter and Gamble: lead

Study Sites (1)

Oral Health Science Center

Mason, Ohio, 45040, United States

Location

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Clinical Trial Manager
• Organization: The Procter & Gamble Company

peters.j.2@pg.com

513-622-2489

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 6, 2018
• Study Start: May 8, 2018
• Primary Completion: June 22, 2018
• Study Completion: June 22, 2018
• Last Updated: September 4, 2019
• Results First Posted: September 4, 2019

Record last verified: 2019-08

Locations

US (1)