Edentulous JawNCT05441527
Use of Two Dissolvable Therapeutics Under Removable Partial Dentures
A study testing MI Paste, then, Biotene Dry Mouth Gel and Biotene Dry Mouth Gel, then, MI Paste in people with Edentulous Jaw and Edentulous Mouth, run by University of Iowa at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Jaw, Edentulous Mouth
- What is being tested?
- MI Paste, then, Biotene Dry Mouth Gel and Biotene Dry Mouth Gel, then, MI Paste
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2022to 27 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa College of Dentistry
Iowa City, Iowa, 52242
About this study
Official title: Use of Two Dissolvable Therapeutics Under Removable Partial Dentures: Reported Effects on Denture Comfort, Retention, and Dry Mouth Conditions
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.
Read more
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.
- Conditions
- Edentulous Jaw, Edentulous Mouth
- Being tested
- MI Paste, then, Biotene Dry Mouth Gel, Biotene Dry Mouth Gel, then, MI Paste
- Medical subject headings
- Jaw, Edentulous, Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MI Paste, then, Biotene Dry Mouth GelDevice
1 milliliter of product will be applied daily to the intaglio (i.e., underside) of the patient's removable prosthesis and seated intraorally.
Biotene Dry Mouth Gel, then, MI PasteDevice
1 milliliter of product will be applied daily to the intaglio (i.e., underside) of the patient's removable prosthesis and seated intraorally.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MI Paste, then, Biotene Dry Mouth Gel |
| 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. Receives: Device: Biotene Dry Mouth Gel, then, MI Paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start30 Jun 2022
- Primary completion27 May 2024
- Study completion27 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Edentulous JawStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Bowers, University of Iowa
- Investigators
- Robert Bowers, DDS, Principal investigator, University of Iowa College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441527
- Sponsor's protocol ID
- 202104384
- Status last verified
- Nov 2025
- First submitted
- 28 Jun 2022
- Last updated
- 25 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Two Dissolvable Therapeutics Under Removable Partial Dentures: Reported Effects on Denture Comfort, Retention, and Dry Mouth Conditions
- ClinicalTrials.gov ID
- NCT05441527
- Acronym / sponsor ID
- 202104384
- Conditions
- Edentulous Jaw, Edentulous Mouth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 27 May 2024 (actual)
- Study completion
- 27 May 2024 (actual)
- First posted
- 1 Jul 2022 (actual)
- Results
- Posted 25 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MI Paste, then, Biotene Dry Mouth Gel | Experimental | Device: MI Paste, then, Biotene Dry Mouth GelSubjects 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. |
| Biotene Dry Mouth Gel, then, MI Paste | Experimental | Device: Biotene Dry Mouth Gel, then, MI PasteSubjects 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MI Paste, then, Biotene Dry Mouth Gel1 milliliter of product will be applied daily to the intaglio (i.e., underside) of the patient's removable prosthesis and seated intraorally. | Device | MI Paste, then, Biotene Dry Mouth Gel |
| Biotene Dry Mouth Gel, then, MI Paste1 milliliter of product will be applied daily to the intaglio (i.e., underside) of the patient's removable prosthesis and seated intraorally. | Device | Biotene Dry Mouth Gel, then, MI Paste |
Primary outcome
Change From Baseline in Patient Comfort for as Assessed by Numerical Scale.
Time frame: 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.
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Dynamic vs. Static Jaw Relations in Implant-Supported Prostheses: Chewing Efficiency
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Bowers, DDS principal investigator
University of Iowa College of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MI Paste, then, Biotene Dry Mouth Gel and Biotene Dry Mouth Gel, then, MI Paste in people with Edentulous Jaw and Edentulous Mouth, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Patient Comfort for as Assessed by Numerical Scale. (time frame: Baseline, 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.