Assessing Effects of a Denture Gel on Gum Abrasions

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Test Group	Treatment Gel	-
Control Group	Sham Control	-

Primary Outcome Measures

Name	Time	Method
Mucosal Assessment	Week 4	The mucosal region under the denture was assessed with one score per arch (two total arches) each arch is scored ranging from 0(better) - 3(worse). The scores are then summed for a total score. The scale is measured as follows: 0 = pink firm tissue absent of redness and inflammation; 1 = mild redness or inflammation - slight change in color and little change in texture; 2 = moderate redness and/or inflammation - moderate glazing, redness, edema and hypertrophy 3 = severe redness and/or inflammation - marked redness and hypertrophy.
Abrasion Assessment (Number)	Week 4	The total number of abrasions pre-food challenge
Abrasion Assessment (Size)	Week 4	The average size/area (in mm) of the total number of abrasions pre-food challenge