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Dec. 26, 2024

Dec. 26, 2024

jRCT1032240582

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

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

Junichi Furuya

Showa University School of Dentistry Department of Oral Health Management, Division of Oral Function Management

2-1-1 Kitasenzoku, Ota-ku, Tokyo

+81-337871151

furuya-j@dent.showa-u.ac.jp

Ryo Sugiki

Showa University School of Dentistry Department of Oral Health Management, Division of Oral Function Management

2-1-1 Kitasenzoku, Ota-ku, Tokyo

+81-337871151

gd23-r011@dent.showa-u.ac.jp

Pending

Dec. 26, 2024

26

Interventional

randomized controlled trial

single blind

active control

crossover assignment

treatment purpose

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

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.

No limit
No limit

Both

Xerostomia

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.

D014987

Retentive strength of duplicate denture after 30 minutes in each test sample

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).

not applicable
not applicable
Ethics Committee on Research Involving Human Subjects at Showa University
1-5-8 Hatanodai Shinagawa-ku Tokyo, Tokyo

+81-3-3784-8129

m-rinri@ofc.showa-u.ac.jp
Approval

No

none