A Self-controlled Clinical Trial on Denture Adhesives Used for Elderly Removable Denture Wearers
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- The University of Hong Kong
- Enrollment
- 94
- Locations
- 1
- Primary Endpoint
- masticatory efficiency
Study Overview
Brief 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.
Detailed Description
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.
Details of the data collection methods are described below:
A. Oral condition
- Oral mucosa moisture:
A non-invasive oral moisture checking device (Mucus III, Life Co. Saitama, Japan) will be placed on the tongue and bilateral buccal mucosa of the participants to measure their oral moisture level (Murakami et al., 2009). 2. Dentition
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects can communicate in Cantonese, Mandarin or English;
- •Subjects who wear either or both removable partial dentures (RPDs);
- •Subjects meet either one of the following criteria for extensive RPD: a. the corresponding arch has no posterior teeth (residual root will not be counted in) on one side or both sides; b. the corresponding arch has over half of the natural teeth missing (remaining teeth ≤ 8);
- •Participants with both upper and lower dentures meeting the requirement of "extensive RPD" will be included in "both dentures group", and participants with either upper or lower denture eligible will be included in "single denture group".
Exclusion Criteria
- •Individuals who are unable to communicate clearly or having dementia;
- •Patients who are mostly bed-ridden, or suffering from infectious or life-threatening disease;
- •Individuals who are currently using denture adhesive;
- •Individuals who are allergic to denture adhesive;
- •Individuals whose denture is implant-supported or contraindicated for application of denture adhesive.
Outcomes
Primary Outcomes
masticatory efficiency
Time Frame: from baseline to 12-week follow-up
A colour-changeable chewing gum (XYLITOL, Lotte Co., Ltd., Saitama, Japan) will be applied to evaluate the masticatory efficiency of the participants. After 90 seconds of chewing, the chewed gum will be collected and the level of color change will be measured in a 5-level visual scale (higher scale indicates better masticatory efficiency) and by a colorimeter (Shenzhen Threenh Technology Co., Ltd., Shenzhen, China). Three readings will be taken: at the centre and approximately 4 mm to its right and left, to obtain a mean a\* value (CIE-L\* a\* b\* colour system) (Fan et al., 2020).
Secondary Outcomes
No secondary outcomes reported