Back to resultsEvaluate Dental Plaque Benefit of a Preventive Treatment Gel
Primary Purpose
Dental Plaque
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Preventive Gel
Marketed Control
Sponsored by
About this trial
This is an interventional prevention trial for Dental Plaque
Eligibility Criteria
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.
Sites / Locations
- Oral Health Science Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Preventive Gel
Marketed Control
Arm Description
0.4% stannous fluoride
0.243 % Sodium Fluoride
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Digital Plaque Imaging
Total percent dental plaque area
Overall Baseline Mean Digital Plaque Imaging
Total percent dental plaque area
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03546491
Brief Title
Evaluate Dental Plaque Benefit of a Preventive Treatment Gel
Official Title
A Clinical Study to Evaluate Anti-Plaque Benefit of a Gel in a Modified- 4 Day Plaque Model
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 8, 2018 (Actual)
Primary Completion Date
June 22, 2018 (Actual)
Study Completion Date
June 22, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Procter and Gamble
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Preventive Gel
Arm Type
Experimental
Arm Description
0.4% stannous fluoride
Arm Title
Marketed Control
Arm Type
Active Comparator
Arm Description
0.243 % Sodium Fluoride
Intervention Type
Drug
Intervention Name(s)
Preventive Gel
Intervention Description
0.4% Stannous Fluoride
Intervention Type
Drug
Intervention Name(s)
Marketed Control
Intervention Description
0.243% Sodium Fluoride
Primary Outcome Measure Information:
Title
Mean Turesky Modified Quigley-Hein Index at Day 4
Description
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.
Time Frame
Day 4
Secondary Outcome Measure Information:
Title
Mean Turesky Modified Quigley-Hein Index at Baseline
Description
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.
Time Frame
Baseline
Title
Digital Plaque Imaging
Description
Total percent dental plaque area
Time Frame
Day 4
Title
Overall Baseline Mean Digital Plaque Imaging
Description
Total percent dental plaque area
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Oral Health Science Center
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
12. IPD Sharing Statement
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Evaluate Dental Plaque Benefit of a Preventive Treatment Gel
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