Evaluation of the denture retention under the use of denture stability materials developed for patients with dry mouth.

JRCT ID: jRCT1032240582

Registered date:26/12/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Xerostomia
• Date of first enrollment: 26/12/2024
• Target sample size: 26
• Study type: Interventional

Intervention(s)

Duplicate the study participants' current dentures.
Then, two samples of a denture adhesive for xerostomia and a cream-type denture adhesive that had been shown to be useful in previous research on palate plate experiments, as well as a control with no sample applied, were applied and pressed into the mouth, and a tensile test was performed.
At that time, the retention strength is measured.
After implementation, a usability survey will be administered to study participants.

Outcome(s)

• Primary Outcome: Retentive strength of duplicate denture after 30 minutes in each test sample

Secondary Outcome

1:Retentive strength of duplicate denture when test sample is not used.
2:Retentive strength of duplicate denture at 0, 10, and 20 minutes for each test sample.
3:Oral moistness.
4:Results of usability questionnaire (VAS values).

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients who visit the Oral Function Management Department at Showa University Dental Hospital
2) Patients who have had maxillary complete dentures made in our department and are undergoing regular checkups
3) Individuals who have given written informed consent to participate in this study

Exclude criteria

1) Those with oral mucositis or other abnormal findings.
2) Persons who use drugs that affect salivary secretion on the day of measurement.
(tricyclic and tetracyclic antidepressants, antihypertensive drugs such as loop diuretics and calcium channel blockers, antiparkinsonian drugs such as anticholinergics and L-dopa containing preparations).
3) Persons who have experienced hypersensitivity symptoms due to the test sample.
4) Persons who have difficulty swallowing.
5) Persons who are deemed ineligible as research subjects by the investigator.

Related Information

• Primary Sponsor: Junichi Furuya