Assessing Effects of a Denture Gel on Gum Abrasions

NCT04913636 | Completed Results FDA Device

• 1 other identifier: 2020089
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Gum Injury

Outcome Measures

Primary Outcomes (12)

• Abrasion Assessment (Number)

  The total number of abrasions pre-food challenge

  Day 3

• Abrasion Assessment (Size)

  The average size/area (in mm) of the total number of abrasions pre-food challenge

  Day 3

• Abrasion Assessment (Number)

  The total number of abrasions pre-food challenge

  Day 6

• Abrasion Assessment (Number)

  The total number of abrasions pre-food challenge

  Week 2

• Abrasion Assessment (Number)

  The total number of abrasions pre-food challenge

  Week 4

• Abrasion Assessment (Size)

  The average size/area (in mm) of the total number of abrasions pre-food challenge

  Day 6

• Abrasion Assessment (Size)

  The average size/area (in mm) of the total number of abrasions pre-food challenge

  Week 2

• Abrasion Assessment (Size)

  The average size/area (in mm) of the total number of abrasions pre-food challenge

  Week 4

• Mucosal Assessment

  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.

  Day 3

• Mucosal Assessment

  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.

  Day 6

• Mucosal Assessment

  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.

  Week 2

• Mucosal Assessment

  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.

  Week 4

Study Arms (2)

Test Group

EXPERIMENTAL

Device: Treatment Gel

Control Group

SHAM COMPARATOR

Other: Sham Control

Interventions

Treatment Gel DEVICE

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.

Test Group

Sham Control OTHER

Subjects will perform their regular denture cleaning routine.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Procter and Gamble: lead

Study Sites (1)

Salus Research

Fort Wayne, Indiana, 46825, United States

Location

Results Point of Contact

• Title: Clinical Trial Manager
• Organization: Procter & Gamble

conde.e.1@pg.com

513-622-4601

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 4, 2021
• Study Start: June 1, 2021
• Primary Completion: June 29, 2021
• Study Completion: June 29, 2021
• Last Updated: June 28, 2022
• Results First Posted: June 28, 2022

Record last verified: 2022-06

Locations

US (1)