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Dissolvable Therapeutics for Denture Comfort

N/A
Waitlist Available
Led By Robert Bowers, DDS
Research Sponsored by University of Iowa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-99
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 week
Awards & highlights

Study Summary

This trial is investigating whether two possible treatments, MI Paste and Biotene Dry Mouth Gel, can help improve the comfort and function of dentures for older adults.

Who is the study for?
This trial is for adults aged 18-99 who wear removable dentures made within the last 10 years at the University of Iowa College of Dentistry. It's not suitable for those with lactose intolerance, casein allergy, multiple allergies to food or cosmetics, or if their dentures fit poorly and need remaking.Check my eligibility
What is being tested?
The study tests two products: MI Paste and Biotene Dry Mouth Gel under partial dentures. The goal is to see which improves comfort, retention, and dry mouth symptoms in patients with xerostomia (dry mouth) compared to those with normal saliva production.See study design
What are the potential side effects?
Potential side effects may include discomfort from product taste or texture under the denture. Since participants are excluded if they have relevant allergies (like lactose intolerance), significant allergic reactions should be rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 99 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 week for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in patient comfort for Biotene Dry Mouth Gel as assessed by numerical scale.
Change from baseline in patient comfort for MI Paste as assessed by numerical scale.
Change from baseline in retention for Biotene Dry Mouth Gel as assessed by numerical scale.
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: MI Paste, then, Biotene Dry Mouth GelExperimental Treatment1 Intervention
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.
Group II: Biotene Dry Mouth Gel, then, MI PasteExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of IowaLead Sponsor
442 Previous Clinical Trials
878,542 Total Patients Enrolled
Robert Bowers, DDSPrincipal InvestigatorUniversity of Iowa College of Dentistry

Media Library

Biotene Dry Mouth Gel, then, MI Paste Clinical Trial Eligibility Overview. Trial Name: NCT05441527 — N/A
Toothless Jaw Research Study Groups: MI Paste, then, Biotene Dry Mouth Gel, Biotene Dry Mouth Gel, then, MI Paste
Toothless Jaw Clinical Trial 2023: Biotene Dry Mouth Gel, then, MI Paste Highlights & Side Effects. Trial Name: NCT05441527 — N/A
Biotene Dry Mouth Gel, then, MI Paste 2023 Treatment Timeline for Medical Study. Trial Name: NCT05441527 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies in this clinical trial for potential participants?

"According to the clinicaltrials.gov listing, this medical study is not presently recruiting patients and has been dormant since September 7th 2022. However, there are 48 alternative trials actively searching for participants as of now."

Answered by AI

To whom is this medical research available?

"To participate in this medical experiment, applicants must possess a dentulous jaw and be between 18-99 years of age. Around 130 individuals are anticipated to join the trial."

Answered by AI

Is the age requirements for this research limited to individuals 85 years of age or younger?

"The minimum age for enrollment in this trial is 18, with the upper limit set at 99."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What site did they apply to?
University of Iowa College of Dentistry
~16 spots leftby Jun 2024