Gum InjuryNCT04913636

Assessing Effects of a Denture Gel on Gum Abrasions

A study testing Treatment Gel in people with Gum Injury, run by Procter and Gamble at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Gum Injury
What is being tested?: Treatment Gel
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 38 participants
Where: 1 siteUnited States
Study dates: 1 Jun 2021to 29 Jun 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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;

Show all 11Show fewer

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Salus Research
Fort Wayne, Indiana, 46825

Other trials in United States

About this study

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

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.

Read the 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
Being tested: Treatment Gel, Sham Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT04913636
Study group	Role	What they receive
Test Group	Experimental	Not described Receives: Device: Treatment Gel
Control Group	Sham comparator	Not described Receives: Other: Sham Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Abrasion Assessment (Number)
The total number of abrasions pre-food challenge
Measured: Day 3
Abrasion Assessment (Size)
The average size/area (in mm) of the total number of abrasions pre-food challenge
Measured: Day 3
Abrasion Assessment (Number)
The total number of abrasions pre-food challenge
Measured: Day 6
Abrasion Assessment (Number)
The total number of abrasions pre-food challenge
Measured: Week 2
Abrasion Assessment (Number)
The total number of abrasions pre-food challenge
Measured: Week 4
Abrasion Assessment (Size)
The average size/area (in mm) of the total number of abrasions pre-food challenge
Measured: Day 6
Abrasion Assessment (Size)
The average size/area (in mm) of the total number of abrasions pre-food challenge
Measured: Week 2
Abrasion Assessment (Size)
The average size/area (in mm) of the total number of abrasions pre-food challenge
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202129 Jun 2021

First posted4 Jun 2021
Study start1 Jun 2021
Primary completion29 Jun 2021
Study completion29 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Gum InjuryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04913636
Sponsor's protocol ID: 2020089
Status last verified: Jun 2022
First submitted: 28 May 2021
Last updated: 28 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Gum Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Clinical Study to Determine the Effect Denture Gel Has on the Prevention of Gum Abrasions
ClinicalTrials.gov ID: NCT04913636
Acronym / sponsor ID: 2020089
Conditions: Gum Injury
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Procter and GambleIndustry (pharma, biotech, devices)
Study start: 1 Jun 2021 (actual)
Primary completion: 29 Jun 2021 (actual)
Study completion: 29 Jun 2021 (actual)
First posted: 4 Jun 2021 (actual)
Results: Posted 28 Jun 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Test Group	Experimental	Device: Treatment Gel
Control Group	Sham comparator	Other: Sham Control

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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;

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Treatment GelIn 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.	Device	Test Group
Sham ControlSubjects will perform their regular denture cleaning routine.	Other	Control Group

Primary outcome

Abrasion Assessment (Number)
Time frame: Day 3
The total number of abrasions pre-food challenge
Abrasion Assessment (Size)
Time frame: Day 3
The average size/area (in mm) of the total number of abrasions pre-food challenge
Abrasion Assessment (Number)
Time frame: Day 6
The total number of abrasions pre-food challenge
Abrasion Assessment (Number)
Time frame: Week 2
The total number of abrasions pre-food challenge
Abrasion Assessment (Number)
Time frame: Week 4
The total number of abrasions pre-food challenge
Abrasion Assessment (Size)
Time frame: Day 6
The average size/area (in mm) of the total number of abrasions pre-food challenge
Abrasion Assessment (Size)
Time frame: Week 2
The average size/area (in mm) of the total number of abrasions pre-food challenge
Abrasion Assessment (Size)
Time frame: Week 4
The average size/area (in mm) of the total number of abrasions pre-food challenge
Mucosal Assessment
Time frame: 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.
Mucosal Assessment
Time frame: 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.
Mucosal Assessment
Time frame: 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.
Mucosal Assessment
Time frame: 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.

Results and safety

Results posted to the registry on 28 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test Group	18	18
Control Group	20	20

Primary outcome: Abrasion Assessment (Number)

Time frame: Day 3. Mean (Standard Error). Unit: number of abrasions

Measure	Test Group n = 16	Control Group n = 20
Value	3.65 (.518)	4.11 (.461)

Primary outcome: Abrasion Assessment (Size)

Time frame: Day 3. Mean (Standard Error). Unit: mm

Measure	Test Group n = 16	Control Group n = 20
Value	6.77 (.731)	7.24 (.653)

Primary outcome: Abrasion Assessment (Number)

Time frame: Day 6. Mean (Standard Error). Unit: number of abrasions

Measure	Test Group n = 15	Control Group n = 18
Value	2.25 (.731)	3.66 (.654)

Primary outcome: Abrasion Assessment (Number)

Time frame: Week 2. Mean (Standard Error). Unit: number of abrasions

Measure	Test Group n = 15	Control Group n = 18
Value	2.23 (.688)	2.48 (.627)

Adverse events

Time frame: Adverse event data were collected for all four weeks of study duration.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Group	0 of 18 (0%)	2 of 18 (11.1%)	0 of 18
Control Group	0 of 20 (0%)	2 of 20 (10%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Treatment Gel in people with Gum Injury, run by Procter and Gamble at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Abrasion Assessment (Number) (time frame: Day 3). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04913636.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.