MedTrace Logo

Denture Adhesives for Elderly Denture Wearers

NCT04927767 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2021-06-16

No results posted yet for this study

Summary

Because of continuous change of the supporting oral tissues, removable dentures can gradually lose retention and stability, resulting in reduced masticatory efficiency. Denture adhesive is a commercially available material used to adhere a denture to the oral mucosa. Our previous review indicated that denture adhesive can improve denture retention, bite force and masticatory performance of complete denture wearers. However, related studies in partial dentures are rare. Therefore, this study aims to investigate the effects of denture adhesives on the masticatory performance and oral health related quality of life of removable partial denture and complete denture wearers.

Participants will be identified and recruited from the patient pool of the Prince Philip Dental Hospital (PPDH). Target patients are those who have problems with their existing dentures (for example, dissatisfied denture retention and stability, or reduced chewing efficiency), but do not plan to have new dentures. After sample size calculation, 47 participants are expected to be recruited for this clinical trial.

In this study, each participant will be interviewed by a trained interviewer and undergo a clinical examination. Information about the oral condition, denture condition, masticatory performance, oral health related quality of life, socio-demographic and other data will be recorded. Saliva samples will be collected for analysis of oral microorganisms.

A commercial copolymer-based cream adhesive (Polident, GlaxoSmithKline, Sussex, UK) is selected as the denture adhesive. Participants will be shown to apply the adhesive following the manufacturer's instructions. The denture is pressed firmly into place, then held firmly as the participant bites down to secure it. Participants will be instructed to apply the adhesive twice daily with an 8-hour interval.

Outcome measurements will be taken before application of denture adhesives, 1 week, 4 weeks and 12 weeks after usage of denture adhesives.

Conditions

  • Problem With Dentures

Interventions

DEVICE

denture adhesive

Denture adhesive is a commercially available denture care product used to adhere a denture to the oral mucosa, in order to improve the retention and stability.

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Katherine Chiu Man Leung, PhD · The University of Hong Kong

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Hong Kong

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04927767 on ClinicalTrials.gov