NCT04913636|CompletedResultsFDA Device
Assessing Effects of a Denture Gel on Gum Abrasions
A Pilot Clinical Study to Determine the Effect Denture Gel Has on the Prevention of Gum Abrasions
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Sponsor study identifier
interventional
38
1 country
1
Study Start
June 1, 2021
Actual (reported)Primary Completion
June 29, 2021
Actual (reported)Study Completion
June 29, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 29, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 28, 2021
Actual (reported)June 1, 2021
Actual (reported)June 4, 2021
Actual (reported)June 29, 2021
Actual (reported)June 29, 2021
Actual (reported)June 28, 2022
Actual (reported)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
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
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.
Subjects will perform their regular denture cleaning routine.
Salus Research
Fort Wayne, Indiana, 46825, United States
38 participants (actual enrollment reported by the registry).
First Submitted
May 28, 2021
First Posted
June 4, 2021
Study Start
June 1, 2021
Actual (reported)Acute Effects of TCIG vs ECIG in PLWH
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 29, 2021
Actual (reported)Study Completion
June 29, 2021
Actual (reported)Last Updated
June 28, 2022
Results First Posted
June 28, 2022
Record last verified: 2022-06
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Source: ClinicalTrials.gov.
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