Trial Outcomes & Findings for Use of Two Dissolvable Therapeutics Under Removable Partial Dentures (NCT NCT05441527)

Results Overview

Comfort will be measured on a numerical scale of 0 to 10, where 0 is very dissatisfied and 10 is very satisfied.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

67 participants

Primary outcome timeframe

Baseline, 1 week

Results posted on

2025-11-25

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
First Intervention (7 Days) STARTED	29	24
First Intervention (7 Days) Received Intervention	29	24
First Intervention (7 Days) COMPLETED	29	24
First Intervention (7 Days) NOT COMPLETED	0	0
Second Intervention (7 Days) STARTED	29	24
Second Intervention (7 Days) COMPLETED	29	23
Second Intervention (7 Days) NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Biotene, Then MI Paste n=29 Participants 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.	MI Paste, Then Biotene n=24 Participants 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.	Total n=53 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=29 Participants	0 Participants n=24 Participants	0 Participants n=53 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=29 Participants	11 Participants n=24 Participants	19 Participants n=53 Participants
Age, Categorical >=65 years	21 Participants n=29 Participants	13 Participants n=24 Participants	34 Participants n=53 Participants
Sex: Female, Male Female	18 Participants n=29 Participants	13 Participants n=24 Participants	31 Participants n=53 Participants
Sex: Female, Male Male	11 Participants n=29 Participants	11 Participants n=24 Participants	22 Participants n=53 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	29 participants n=29 Participants	24 participants n=24 Participants	53 participants n=53 Participants

PRIMARY outcome

Timeframe: 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.

Comfort will be measured on a numerical scale of 0 to 10, where 0 is very dissatisfied and 10 is very satisfied.

Outcome measures

Outcome measures
Measure	Biotene n=52 Participants Subjects in this arm will use either 1 milliliter of Biotene Dry Mouth gel for either the first 7 days of the study or the last 7 days of the study.	MI Paste n=53 Participants 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.
Change From Baseline in Patient Comfort for as Assessed by Numerical Scale.	0.99 units on a scale Standard Deviation 1.64	1.16 units on a scale Standard Deviation 1.70

PRIMARY outcome

Timeframe: 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.

Retention will be measured on a numerical scale of 0 to 10, where 0 is very dissatisfied and 10 is very satisfied.

Outcome measures

Outcome measures
Measure	Biotene n=52 Participants Subjects in this arm will use either 1 milliliter of Biotene Dry Mouth gel for either the first 7 days of the study or the last 7 days of the study.	MI Paste n=53 Participants 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.
Change From Baseline in Retention as Assessed by Numerical Scale.	0.56 units on a scale Standard Deviation 1.85	0.97 units on a scale Standard Deviation 1.39

Adverse Events

Biotene Dry Mouth Gel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

MI Paste

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robert Bowers

University of Iowa

Phone: (319) 467-3199

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place