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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group | Experimental |
| |
| Control Group | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment Gel | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Abrasion Assessment (Number) | The total number of abrasions pre-food challenge | Day 3 |
| Abrasion Assessment (Size) | The average size/area (in mm) of the total number of abrasions pre-food challenge | Day 3 |
| Abrasion Assessment (Number) | The total number of abrasions pre-food challenge | Day 6 |
| Abrasion Assessment (Number) | The total number of abrasions pre-food challenge | Week 2 |
| Abrasion Assessment (Number) | The total number of abrasions pre-food challenge | Week 4 |
| Abrasion Assessment (Size) | The average size/area (in mm) of the total number of abrasions pre-food challenge | Day 6 |
| Abrasion Assessment (Size) | The average size/area (in mm) of the total number of abrasions pre-food challenge | Week 2 |
| Abrasion Assessment (Size) | The average size/area (in mm) of the total number of abrasions pre-food challenge | Week 4 |
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Inclusion Criteria:
In order to be included in the study, each subject must:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salus Research | Fort Wayne | Indiana | 46825 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control Group | Sham Control: Subjects will perform their regular denture cleaning routine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Abrasion Assessment (Number) | The total number of abrasions pre-food challenge | Posted | Mean | Standard Error | number of abrasions | Day 3 |
|
Adverse event data were collected for all four weeks of study duration.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mouth Ulceration | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Manager | Procter & Gamble | 513-622-4601 | conde.e.1@pg.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 12, 2021 | May 19, 2022 | Prot_SAP_000.pdf |
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|
| Sham Control | Other | Subjects will perform their regular denture cleaning routine. |
|
| 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. | 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. | 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. | 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. | Week 4 |
| BG001 | Control Group | Sham Control: Subjects will perform their regular denture cleaning routine. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Post-Peanut Gum Abrasion Evaluation (number) | Subject dropped from experimental leg | Median | Standard Deviation | number of abrasions |
|
| Post-Peanut Challenge Evaluation (size) | Subject dropped from experimental leg | Mean | Standard Deviation | mm |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Abrasion Assessment (Size) | The average size/area (in mm) of the total number of abrasions pre-food challenge | Posted | Mean | Standard Error | mm | Day 3 |
|
|
|
| Primary | Abrasion Assessment (Number) | The total number of abrasions pre-food challenge | Posted | Mean | Standard Error | number of abrasions | Day 6 |
|
|
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| Primary | Abrasion Assessment (Number) | The total number of abrasions pre-food challenge | Posted | Mean | Standard Error | number of abrasions | Week 2 |
|
|
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| Primary | Abrasion Assessment (Number) | The total number of abrasions pre-food challenge | Posted | Mean | Standard Error | number of abrasions | Week 4 |
|
|
|
| Primary | Abrasion Assessment (Size) | The average size/area (in mm) of the total number of abrasions pre-food challenge | Posted | Mean | Standard Error | mm | Day 6 |
|
|
|
| Primary | Abrasion Assessment (Size) | The average size/area (in mm) of the total number of abrasions pre-food challenge | Posted | Mean | Standard Error | mm | Week 2 |
|
|
|
| Primary | Abrasion Assessment (Size) | The average size/area (in mm) of the total number of abrasions pre-food challenge | Posted | Mean | Standard Error | mm | Week 4 |
|
|
|
| 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. | Posted | Mean | Standard Error | units on a scale | Day 3 |
|
|
|
| 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. | Posted | Mean | Standard Error | units on a scale | Day 6 |
|
|
|
| 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. | Posted | Mean | Standard Error | units on a scale | Week 2 |
|
|
|
| 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. | Posted | Mean | Standard Error | units on a scale | Week 4 |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 2 |
| 18 |
| EG001 | Control Group | Sham Control: Subjects will perform their regular denture cleaning routine. | 0 | 20 | 0 | 20 | 2 | 20 |
| Desquamation Oral | Gastrointestinal disorders | Non-systematic Assessment |
|
PI should disclose plans to sponsor prior to public release.
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|