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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MI Paste, then, Biotene Dry Mouth Gel | Experimental | Subjects in this arm will use 1 milliliter of MI Paste daily for 7 days. Then, the subjects in this arm will use 1 milliliter of Biotene Dry Mouth gel daily for 7 days. There will be no wash-out period between the two products. |
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| Biotene Dry Mouth Gel, then, MI Paste | Experimental | Subjects in this arm will use 1 milliliter of Biotene Dry Mouth gel for 7 days. Then, the subjects in this arm will use 1 milliliter of MI Paste for 7 days. There will be no wash-out period between the two products. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MI Paste, then, Biotene Dry Mouth Gel | Device | 1 milliliter of product will be applied daily to the intaglio (i.e., underside) of the patient's removable prosthesis and seated intraorally. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 1 week |
| 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. | Baseline, 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Bowers, DDS | University of Iowa College of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa College of Dentistry | Iowa City | Iowa | 52242 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (7 Days) |
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| Second Intervention (7 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1 week |
|
2 weeks
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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 | Biotene Dry Mouth Gel | Subjects in this arm will use 1 milliliter of Biotene Dry Mouth gel for either the first 7 days of the study or the last 7 days of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Bowers | University of Iowa | (319) 467-3199 | robert-bowers@uiowa.edu |
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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 28, 2024 | May 13, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| D009066 | Mouth, Edentulous |
| ID | Term |
|---|---|
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
| D009059 | Mouth Diseases |
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| Biotene Dry Mouth Gel, then, MI Paste | Device | 1 milliliter of product will be applied daily to the intaglio (i.e., underside) of the patient's removable prosthesis and seated intraorally. |
|
| NOT COMPLETED |
|
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| MI Paste |
Subjects in this arm will use either 1 milliliter of MI Paste for the first 7 days of the study or for the last 7 days of the study. |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1 week |
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | MI Paste | Subjects in this arm will use 1 milliliter of MI Paste gel for either the first 7 days of the study or the last 7 days of the study. | 0 | 53 | 0 | 53 | 0 | 53 |
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| D014076 |
| Tooth Diseases |