Clinical trial NCT04913636: Assessing Effects of a Denture Gel on Gum Abrasions
Official title: A Pilot Clinical Study to Determine the Effect Denture Gel Has on the Prevention of Gum Abrasions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gum Injury
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2021-06-04
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 for 4 weeks. Subjects will have an Oral Soft Tissue exam, a Mucosa Condition Assessment, and a Pre-Gum Abrasion Evaluation followed by a peanut challenge and then have a Post-Gum Abrasion Evaluation at designated timepoints.

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 visit, an Oral Soft Tissue exam, a Mucosa Condition Assessment and a Gum Abrasion Evaluation will be performed. At Baseline, the subjects will be randomized to a treatment group. At Baseline, Week 2, and Week 4 subjects will be asked to eat 20 grams of peanuts 4 times for a total consumption of 80 g of peanuts (subjects will be permitted to take breaks if needed and drink small sips of water). Following the peanut challenge, a licensed dental professional will re-evaluate the number and size of abrasions. Subjects will receive a consumer questionnaire to complete as well prior to the Baseline, Week 2, and Week 4 assessments.

Eligibility criteria: Inclusion Criteria:

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 Criteria:

* 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

Primary outcomes:
measure: Abrasion Assessment (Number)
timeFrame: Day 3
measure: Abrasion Assessment (Size)
timeFrame: Day 3
measure: Abrasion Assessment (Number)
timeFrame: Day 6
measure: Abrasion Assessment (Number)
timeFrame: Week 2
measure: Abrasion Assessment (Number)
timeFrame: Week 4
measure: Abrasion Assessment (Size)
timeFrame: Day 6
measure: Abrasion Assessment (Size)
timeFrame: Week 2
measure: Abrasion Assessment (Size)
timeFrame: Week 4
measure: Mucosal Assessment
timeFrame: Day 3
measure: Mucosal Assessment
timeFrame: Day 6
measure: Mucosal Assessment
timeFrame: Week 2
measure: Mucosal Assessment
timeFrame: Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Salus Research
state: Indiana
Study officials:
References: