NCT04913636

Assessing Effects of a Denture Gel on Gum Abrasions

Completed NA Results posted Last updated 28 June 2022

What this trial tests

NA trial testing Treatment Gel in Gum Injury in 38 participants. Completed in 29 June 2021.

Timeline

1 June 2021

Primary endpoint
29 June 2021

29 June 2021

Quick facts

Lead sponsor	Procter and Gamble
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	38
Start date	1 June 2021
Primary completion	29 June 2021
Estimated completion	29 June 2021
Sites	1 location across United States

Drugs / interventions tested

• Treatment Gel
• Sham Control — full drug profile →

Conditions studied

• Gum Injury — all drugs for Gum Injury →

Sponsor

Procter and Gamble — full company profile →

Who can join

18 and older, any sex, with Gum Injury. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Abrasion Assessment (Number) Primary · Day 3

The total number of abrasions pre-food challenge

Group	Value	95% CI
Test Group	3.65	± .518
Control Group	4.11	± .461

Abrasion Assessment (Size) Primary · Day 3

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

Group	Value	95% CI
Test Group	6.77	± .731
Control Group	7.24	± .653

Abrasion Assessment (Number) Primary · Day 6

The total number of abrasions pre-food challenge

Group	Value	95% CI
Test Group	2.25	± .731
Control Group	3.66	± .654

Abrasion Assessment (Number) Primary · Week 2

The total number of abrasions pre-food challenge

Group	Value	95% CI
Test Group	2.23	± .688
Control Group	2.48	± .627

Abrasion Assessment (Number) Primary · Week 4

The total number of abrasions pre-food challenge

Group	Value	95% CI
Test Group	0.98	± .316
Control Group	1.74	± .288

Abrasion Assessment (Size) Primary · Day 6

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

Group	Value	95% CI
Test Group	2.67	± 1.079
Control Group	5.58	± .981

Abrasion Assessment (Size) Primary · Week 2

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

Group	Value	95% CI
Test Group	3.18	± .523
Control Group	2.20	± .476

Abrasion Assessment (Size) Primary · Week 4

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

Group	Value	95% CI
Test Group	2.15	± .647
Control Group	3.39	± .588

Mucosal Assessment Primary · Day 3

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.

Group	Value	95% CI
Test Group	.97	± .048
Control Group	1.04	± .043

Mucosal Assessment Primary · Day 6

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.

Group	Value	95% CI
Test Group	.77	± .049
Control Group	1.05	± .044

Mucosal Assessment Primary · Week 2

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.

Group	Value	95% CI
Test Group	.70	± .062
Control Group	1.03	± .056

Mucosal Assessment Primary · 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.

Group	Value	95% CI
Test Group	.60	± .062
Control Group	1.06	± .056

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected for all four weeks of study duration.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Test Group

Serious: 0/18 (0%)

Deaths: 0/18

Control Group

Serious: 0/20 (0%)

Deaths: 0/20

Other adverse events (2 terms — click to expand)

Reaction	System	Test Group	Control Group
Mouth Ulceration	Gastrointestinal disorders	—	—
Desquamation Oral	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT04913636 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.