Status:
COMPLETED
Assessing Effects of a Denture Gel on Gum Abrasions
Lead Sponsor:
Procter and Gamble
Conditions:
Gum Injury
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a parallel design study. Up to 40 subjects with a full mandibular and full maxillary dentures will be enrolled into the study. Subjects will use their current denture care +/- a treatment gel ...
Detailed Description
This is a single center, two-treatment, parallel design study. Up to 40 subjects will be enrolled with a full mandibular and full maxillary denture with a history of food related abrasions. At each v...
Eligibility Criteria
Inclusion
- In order to be included in the study, each subject must:
- Be 18 years of age;
- Read, sign, and receive a copy of the Informed Consent prior to initiation of study procedures;
- Have a full maxillary and mandibular denture and wear on a daily basis;
- Have a history of food particles getting under their full denture and causing gum irritation;
- Are willing to abstain from eating at least four hours prior to the visits;
- Are willing to eat 4 X 20 grams of peanuts three times (Baseline, Week 2 and Week 4) without denture adhesive;
- Clean their dentures on a daily basis;
- Agree not to change their regular denture cleaning routine;
- Agree to abstain from using denture adhesive during the study;
- Agree to not participate in any other oral/dental product studies during the study.
Exclusion
- Exhibit evidence of obvious oral pathology, as determined by the Study Dentist, as a result of a mandatory OST examination on the first day of the study;
- Are allergic to any of the ingredients contained in the study product gel;
- Are allergic to peanuts;
- Wear dentures overnight;
- Are insulin-dependent and/or have any health condition(s) which would prevent compliance with study procedures;
- Are routinely using denture adhesive;
- Present with any disease or conditions that could be expected to increase their susceptibility to gum abrasion (like diabetes or xerostomia); or
- Present with any disease or conditions that could be expected to interfere with examination procedures or the subject's safe completion of the study
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2021
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04913636
Start Date
June 1 2021
End Date
June 29 2021
Last Update
June 28 2022
Active Locations (1)
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1
Salus Research
Fort Wayne, Indiana, United States, 46825