CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 38 enrolled
Drug / intervention
Treatment Gel +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04913636
NCT04913636N/ACompleted
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A Pilot Clinical Study to Determine the Effect Denture Gel Has on the Prevention of Gum Abrasions

Procter and Gamble·interventional·Posted Jun 4, 2021·Updated Jun 28, 2022

In Brief

A clinical study evaluating Treatment Gel and Sham Control for Gum Injury. Completed, enrolled 38 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGum Injury
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJun 4, 2021
Enrollment StartJun 1, 2021
Primary CompletionJun 29, 2021
TodayJul 2, 2026
Enrollment to primary: 28 daysPosted 5.1 years ago

Interventions

Treatment Geldevice

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.

Sham Controlother

Subjects will perform their regular denture cleaning routine.