Gum Injury
Conditions
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.
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.
Interventions
DEVICETreatment Gel
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.
OTHERSham Control
Subjects will perform their regular denture cleaning routine.
Sponsors
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abrasion Assessment (Number) | Day 3 | The total number of abrasions pre-food challenge |
| Abrasion Assessment (Size) | Day 3 | The average size/area (in mm) of the total number of abrasions pre-food challenge |
| Mucosal Assessment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Group Treatment Gel: 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. | 18 |
| Control Group Sham Control: Subjects will perform their regular denture cleaning routine. | 20 |
| Total | 38 |
Baseline characteristics
| Characteristic | Test Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 65.7 years STANDARD_DEVIATION 12.39 | 64.4 years STANDARD_DEVIATION 12.55 | 65.0 years STANDARD_DEVIATION 12.32 |
| Post-Peanut Challenge Evaluation (size) | 9.85 mm STANDARD_DEVIATION 7.678 | 5.95 mm STANDARD_DEVIATION 5.275 | 7.74 mm STANDARD_DEVIATION 6.69 |
| Post-Peanut Gum Abrasion Evaluation (number) | 5.18 number of abrasions STANDARD_DEVIATION 3.729 | 3.85 number of abrasions STANDARD_DEVIATION 2.7 | 4.46 number of abrasions STANDARD_DEVIATION 3.237 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 18 Participants | 33 Participants |
| Sex: Female, Male Female | 11 Participants | 14 Participants | 25 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 20 |
| other Total, other adverse events | 2 / 18 | 2 / 20 |
| serious Total, serious adverse events | 0 / 18 | 0 / 20 |
Outcome results
Primary
Abrasion Assessment (Number)
The total number of abrasions pre-food challenge
Time frame: Day 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group | Abrasion Assessment (Number) | 2.25 number of abrasions | Standard Error 0.731 |
| Control Group | Abrasion Assessment (Number) | 3.66 number of abrasions | Standard Error 0.654 |
Primary
Abrasion Assessment (Number)
The total number of abrasions pre-food challenge
Time frame: Week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group | Abrasion Assessment (Number) | 2.23 number of abrasions | Standard Error 0.688 |
| Control Group | Abrasion Assessment (Number) | 2.48 number of abrasions | Standard Error 0.627 |
Primary
Abrasion Assessment (Number)
The total number of abrasions pre-food challenge
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group | Abrasion Assessment (Number) | 0.98 number of abrasions | Standard Error 0.316 |
| Control Group | Abrasion Assessment (Number) | 1.74 number of abrasions | Standard Error 0.288 |
Primary
Abrasion Assessment (Number)
The total number of abrasions pre-food challenge
Time frame: Day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group | Abrasion Assessment (Number) | 3.65 number of abrasions | Standard Error 0.518 |
| Control Group | Abrasion Assessment (Number) | 4.11 number of abrasions | Standard Error 0.461 |
Primary
Abrasion Assessment (Size)
The average size/area (in mm) of the total number of abrasions pre-food challenge
Time frame: Day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group | Abrasion Assessment (Size) | 6.77 mm | Standard Error 0.731 |
| Control Group | Abrasion Assessment (Size) | 7.24 mm | Standard Error 0.653 |
Primary
Abrasion Assessment (Size)
The average size/area (in mm) of the total number of abrasions pre-food challenge
Time frame: Day 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group | Abrasion Assessment (Size) | 2.67 mm | Standard Error 1.079 |
| Control Group | Abrasion Assessment (Size) | 5.58 mm | Standard Error 0.981 |
Primary
Abrasion Assessment (Size)
The average size/area (in mm) of the total number of abrasions pre-food challenge
Time frame: Week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group | Abrasion Assessment (Size) | 3.18 mm | Standard Error 0.523 |
| Control Group | Abrasion Assessment (Size) | 2.20 mm | Standard Error 0.476 |
Primary
Abrasion Assessment (Size)
The average size/area (in mm) of the total number of abrasions pre-food challenge
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group | Abrasion Assessment (Size) | 2.15 mm | Standard Error 0.647 |
| Control Group | Abrasion Assessment (Size) | 3.39 mm | Standard Error 0.588 |
Primary
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.
Time frame: Day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group | Mucosal Assessment | .97 units on a scale | Standard Error 0.048 |
| Control Group | Mucosal Assessment | 1.04 units on a scale | Standard Error 0.043 |
Primary
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.
Time frame: Day 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group | Mucosal Assessment | .77 units on a scale | Standard Error 0.049 |
| Control Group | Mucosal Assessment | 1.05 units on a scale | Standard Error 0.044 |
Primary
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.
Time frame: Week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group | Mucosal Assessment | .70 units on a scale | Standard Error 0.062 |
| Control Group | Mucosal Assessment | 1.03 units on a scale | Standard Error 0.056 |
Primary
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.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group | Mucosal Assessment | .60 units on a scale | Standard Error 0.062 |
| Control Group | Mucosal Assessment | 1.06 units on a scale | Standard Error 0.056 |