N/A N=38 Randomized Single-blind Prevention

Assessing Effects of a Denture Gel on Gum Abrasions

Gum Injury

Bottom Line

View on ClinicalTrials.gov: NCT04913636 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2022

Primary outcome: Primary: Abrasion Assessment (Number) — 3.65; 4.11 number of abrasions

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Treatment Gel (Device); Sham Control (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Procter and Gamble
Primary completion: Jun 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Abrasion Assessment (Number)	0.98; 1.74	—
PRIMARY Abrasion Assessment (Size)	2.15; 3.39	—
PRIMARY Abrasion Assessment (Number)	0.98; 1.74	—
PRIMARY Abrasion Assessment (Number)	0.98; 1.74	—
PRIMARY Abrasion Assessment (Number)	0.98; 1.74	—
PRIMARY Abrasion Assessment (Size)	2.15; 3.39	—
PRIMARY Abrasion Assessment (Size)	2.15; 3.39	—
PRIMARY Abrasion Assessment (Size)	2.15; 3.39	—
PRIMARY Mucosal Assessment	.60; 1.06	—
PRIMARY Mucosal Assessment	.60; 1.06	—
PRIMARY Mucosal Assessment	.60; 1.06	—
PRIMARY Mucosal Assessment	.60; 1.06	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04913636). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.