NCT04913636

Assessing Effects of a Denture Gel on Gum Abrasions

A Pilot Clinical Study to Determine the Effect Denture Gel Has on the Prevention of Gum Abrasions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Procter and Gamble · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gum Injury

Interventions

Type	Name	Description
DEVICE	Treatment Gel	In the evening subjects will perform their regular denture cleaning routine. They will be instructed to sleep without dentures. Subjects will rinse out their mouth with water (if subjects brush their oral mucosa with brush, they will be allowed to continue doing so) and apply the gel to their mucosa where they normally wear upper or lower denture.
OTHER	Sham Control	Subjects will perform their regular denture cleaning routine.

Timeline

• Start date: 2021-06-01
• Primary completion: 2021-06-29
• Completion: 2021-06-29
• First posted: 2021-06-04
• Last updated: 2022-06-28
• Results posted: 2022-06-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study