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The effectiveness of cream and gel denture adhiesive in the complete denture wearers with dry mouth (DADY)

The effectiveness of Denture Adhesive in the patients with dry mouth (DADY)

14

The subjects comprised 14 (3 men and 11 women, aged 57 to 91 years old). Median age of these subjects was 83 years old. All subjects used denture adhesive during the observation period : 7 subjects used "Pitatto kaiteki gel" and other 7 subjects used "New Poligrip Sa".

Since the registration pace was delayed, the study period was extended. However, we decided that it was impossible to achieve the target number of cases, so we decided to discontinue this study. Eventually 14 patients were registered.

No adverse event was observed in all the patients.

We statistically compared the Pi group and the Sa group before and after the use of denture adhesive. Primary outcome: There was no significant difference between the group using "Pitatto kaiteki gel" (Pi group) and the group using "New Poligrip Sa" (Sa group). Secondary outcomes: In Pi group, significant improvement was observed in the moisture content on the dorsal surface of the tongue. In Sa group, significant deterioration was observed in the moisture content on the dorsal surface of the buccal mucosa. No significant differences were not observed in subjective and objective dry mouse, quantity of Candida, redness of the ridge mucosa, changes in the papillae of the dorsal surface of the tongue, and cleaning condition of dentures.

We found that the use of "Pitatto kaiteki gel" had improved the moisture content on the dorsal surface of the tongue.

April. 30, 2022

Dec. 31, 2030

No

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https://jrct.mhlw.go.jp/latest-detail/jRCTs012190005

Okada Kazutaka

Faculty of dental medicine, Hokkaido University

Kita 13 Nisi 7, Kita-ku, Sapporo, Hokkaido

kz@den.hokudai.ac.jp

Nogawa Toshifumi

Hokkaido University Hospital

Kita 13 Nisi 7, Kita-ku, Sapporo, Hokkaido

+81-11-706-4256

t.nogawa@den.hokudai.ac.jp

Complete

July. 31, 2019

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

Complete denture wearers
1. Over 20 years old when informed consent is obtained
2. Inserted a denture before 3 months or more and do not need correction of denture form or occlusal contact
3. Not sufficient satisfaction about the use of dentures
4. Less than 28 oral mucous membrane water content or less than 50 VAS score about dry mouth
5. Written informed consent is obtained after sufficient explanation and full understanding
6. Patients who have never used denture adhiesive within three months before obtaining consent

1. Patients who has a history of hypersensitivity to denture adhesive
2. Patients who has symptoms such as ulcer or pain in mucosa under dentures
3. Patients with dysphagia
4. Patients with jaw defects
5. Patients who can not maintain dentures by themselves
6. Patients who have difficulty meeting their ongoing visits
7. Other reason for inadequacy to admit this study judged by principal investigator or coinvestigators

Both

Edentlism

using a denture adhiesive

Dry mouth

Satisfaction

evaluation of denture stability
Oral health related quality of life
symptoms in the oral cavity
quantity of Candida albicans
masticatory performance
feeling of dry mouth

+81-11-706-7934

July. 16, 2019

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