NCT04927767

Denture Adhesives for Elderly Denture Wearers

Status unknown Phase 2, PHASE3 Last updated 16 June 2021

What this trial tests

Phase 2, PHASE3 trial testing denture adhesive in Problem With Dentures in 94 participants. Status unknown.

Timeline

1 March 2021

Primary endpoint
31 December 2021

31 December 2021

Quick facts

Lead sponsor	The University of Hong Kong
Phase	Phase 2, PHASE3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	94
Start date	1 March 2021
Primary completion	31 December 2021
Estimated completion	31 December 2021
Sites	1 location across Hong Kong

Drugs / interventions tested

• denture adhesive

Conditions studied

• Problem With Dentures — all drugs for Problem With Dentures →

Sponsor

The University of Hong Kong

Who can join

Adults 60 to 85, any sex, with Problem With Dentures. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.