An interventional study of MI Paste, then, Biotene Dry Mouth Gel and Biotene Dry Mouth Gel, then, MI Paste in Edentulous Jaw and Edentulous Mouth, sponsored by University of Iowa. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-25.
Sponsored by University of Iowa · Not applicable, Interventional, and Treatment
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.
171 studies on the registry are indexed under Jaw, Edentulous; 24 are open to participants now.
This study's enrollment of 67 is above the median of 33 across 146 interventional studies indexed under Jaw, Edentulous.
Browse Jaw, Edentulous studies →University of Iowa is the lead sponsor of 276 studies on the registry; 35 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 39 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: MI Paste, then, Biotene Dry Mouth Gel
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.
Device: Biotene 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.
1 milliliter of product will be applied daily to the intaglio (i.e., underside) of the patient's removable prosthesis and seated intraorally.
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
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
| Milestone | Biotene, Then MI Paste | MI Paste, Then Biotene |
|---|---|---|
| Started | 29 | 24 |
| Received intervention | 29 | 24 |
| Completed | 29 | 24 |
| Not completed | 0 | 0 |
| Milestone | Biotene, Then MI Paste | MI Paste, Then Biotene |
|---|---|---|
| Started | 29 | 24 |
| Completed | 29 | 23 |
| Not completed | 0 | 1 |
Comfort will be measured on a numerical scale of 0 to 10, where 0 is very dissatisfied and 10 is very satisfied.
| units on a scale | Biotene | MI Paste |
|---|---|---|
| Change From Baseline in Patient Comfort for as Assessed by Numerical Scale. | 0.99 ± 1.64 | 1.16 ± 1.70 |
Retention will be measured on a numerical scale of 0 to 10, where 0 is very dissatisfied and 10 is very satisfied.
| units on a scale | Biotene Dry Mouth Gel | MI Paste |
|---|---|---|
| Change From Baseline in Retention as Assessed by Numerical Scale. | 0.56 ± 1.85 | 0.97 ± 1.39 |
Collected over 2 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Biotene Dry Mouth Gel | 0/52 (0%) | 0/52 (0%) | 0/52 (0%) |
| MI Paste | 0/53 (0%) | 0/53 (0%) | 0/53 (0%) |
| Age, Categorical(Participants) | Biotene, Then MI Paste | MI Paste, Then Biotene | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 11 | 19 |
| >=65 years | 21 | 13 | 34 |
| Sex: Female, Male(Participants) | Biotene, Then MI Paste | MI Paste, Then Biotene | Total |
|---|---|---|---|
| Female | 18 | 13 | 31 |
| Male | 11 | 11 | 22 |
| Race and Ethnicity Not Collected(Participants) | Biotene, Then MI Paste | MI Paste, Then Biotene | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Biotene, Then MI Paste | MI Paste, Then Biotene | Total |
|---|---|---|---|
| United States | 29 | 24 | 53 |
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University of Iowa