Edentulous Jaw, Edentulous Mouth
Conditions
Brief summary
Older removable denture wearing adults suffer from a complex set of oral health challenges, with relatively few solutions identified at this time. This is substantiated by statistics concerning the geriatric population on the correlation of poor oral health and the degradation of an individual's overall quality of life. The most recent National Health and Nutrition Examination Survey data found that 1 in 8 U.S. adults over the age of 65 are completely edentulous. A shift from complete edentulism to partial edentulism was also seen in this survey data, as the average individual over 65 had only 21 teeth remaining. Thus, partial edentulism remains a significant burden on seniors as well. Clearly, there exists both a great need and desire for improved implementation of proven oral-health strategies among this population, as well as the development of new preventive interventions and minimally invasive treatment strategies beyond traditional denture adhesive products. This proposed clinical trial intends to investigate two such potential treatment aids. In follow-up from our recent pilot study investigating MI Paste's application on the intaglio of complete dentures, in which our current findings have shown that the use of MI Paste can predictably increase the buffering capacity of a patient's saliva, our current proposal targets to further increase the study's sample size to improve the statistical power regarding subjective patient reports. The primary aims of this proposed study are to collect further data on how MI Paste affects patients' subjective evaluations of the comfort and retention of their denture, as well as dry mouth symptoms in patients reporting xerostomia. Furthermore, this study will include a second therapeutic intervention, Biotene Dry Mouth Gel (OTC), which will provide an additional contrast variable involving patient preferences regarding therapeutics under their removable prostheses. We hypothesize that the use of both therapeutics underneath removable dentures will provide added retention and stability to the prosthesis on patient reports, further coinciding with improved evaluations of comfort and function. Additionally, we hypothesize that the subjective improvements in patients self-reporting xerostomia will be of a statistically greater magnitude than those noticed by patients with normal salivary function, as xerostomia has been associated with increased denture discomfort in past literature.
Interventions
DEVICEMI Paste, then, Biotene Dry Mouth Gel
1 milliliter of product will be applied daily to the intaglio (i.e., underside) of the patient's removable prosthesis and seated intraorally.
DEVICEBiotene Dry Mouth Gel, then, MI Paste
1 milliliter of product will be applied daily to the intaglio (i.e., underside) of the patient's removable prosthesis and seated intraorally.
Sponsors
University of Iowa
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-99 * Patients with a removable prosthesis (e.g., partial denture, complete denture) * Removable prosthesis must have been made at the University of Iowa College of Dentistry's Department of Family Dentistry clinic within the past 10 years.
Exclusion criteria
* Casein (i.e., protein found in milk or other dairy products) allergy * Lactose intolerance * Multiple food or cosmetic ingredient allergies in their health history * Ill-fitting dentures that need to be remade or relined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Patient Comfort for as Assessed by Numerical Scale. | Baseline, 1 week | Comfort will be measured on a numerical scale of 0 to 10, where 0 is very dissatisfied and 10 is very satisfied. |
| Change From Baseline in Retention as Assessed by Numerical Scale. | Baseline, 1 week | Retention will be measured on a numerical scale of 0 to 10, where 0 is very dissatisfied and 10 is very satisfied. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Biotene, Then MI Paste Subjects in this arm will use 1 milliliter of Biotene Dry Mouth gel for 7 days. After no wash-out period, the subject will switch to 1 milliliter of MI Paste for 7 days.
1 milliliter of product will be applied daily to the intaglio (i.e., underside) of the patient's removable prosthesis and seated intraorally. | 29 |
| MI Paste, Then Biotene Subjects in this arm will use 1 milliliter of MI Paste for 7 days. After no wash-out period, the subject will switch to 1 milliliter of Biotene for 7 days.
1 milliliter of product will be applied daily to the intaglio (i.e., underside) of the patient's removable prosthesis and seated intraorally. | 24 |
| Total | 53 |
Baseline characteristics
| Characteristic | MI Paste, Then Biotene | Total | Biotene, Then MI Paste |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 34 Participants | 21 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 19 Participants | 8 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 24 participants | 53 participants | 29 participants |
| Sex: Female, Male Female | 13 Participants | 31 Participants | 18 Participants |
| Sex: Female, Male Male | 11 Participants | 22 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 53 |
| other Total, other adverse events | 0 / 52 | 0 / 53 |
| serious Total, serious adverse events | 0 / 52 | 0 / 53 |
Outcome results
Primary
Change From Baseline in Patient Comfort for as Assessed by Numerical Scale.
Comfort will be measured on a numerical scale of 0 to 10, where 0 is very dissatisfied and 10 is very satisfied.
Time frame: Baseline, 1 week
Population: The average of patient comfort was calculated before the intervention. Then, after the intervention, the average of patient comfort was assessed again, and the difference between pre- and post-treatment is reported in alignment with the outcome of change from baseline in patient comfort for as assessed by numerical scale.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biotene | Change From Baseline in Patient Comfort for as Assessed by Numerical Scale. | 0.99 units on a scale | Standard Deviation 1.64 |
| MI Paste | Change From Baseline in Patient Comfort for as Assessed by Numerical Scale. | 1.16 units on a scale | Standard Deviation 1.7 |
Primary
Change From Baseline in Retention as Assessed by Numerical Scale.
Retention will be measured on a numerical scale of 0 to 10, where 0 is very dissatisfied and 10 is very satisfied.
Time frame: Baseline, 1 week
Population: The average of retention was calculated before the intervention. Then, after the intervention, the average of retention was assessed again, and the difference between pre- and post-treatment is reported in alignment with the outcome of change from baseline retention for as assessed by numerical scale.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biotene | Change From Baseline in Retention as Assessed by Numerical Scale. | 0.56 units on a scale | Standard Deviation 1.85 |
| MI Paste | Change From Baseline in Retention as Assessed by Numerical Scale. | 0.97 units on a scale | Standard Deviation 1.39 |