Effectiveness of an Ultrasonic Denture Hygiene Intervention Program Among Community-dwelling Elders

Denture Clinical Trial

Official title:

Effectiveness of an Ultrasonic Denture Hygiene Intervention Program Among Community-dwelling Elders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03522272
• Other study ID #: UW16-266
• Status: Completed
• Phase: Phase 4
• Start date: June 20, 2016
• Est. completion date: June 20, 2017

Study information

• Verified date: April 2018
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objectives: The objective of this study was to assess prospectively the effectiveness of ultrasonic denture hygiene interventions in improving denture cleanliness among community-dwelling elders. Methods: A randomized clinical trial was conducted among community-dwelling elders, in which a total of 66 subjects who received upper metal framework removable partial dentures in the past five years were recruited randomly from a computerized database. They were randomly allocated into three denture hygiene intervention groups: group 1 (mechanical cleaning with a toothbrush and ultrasonic cleaning with cetylpyridinium chloride mouthrinse), group 2 (mechanical cleaning with a toothbrush and ultrasonic cleaning with distilled water) and control (mechanical cleaning with a toothbrush only). Denture cleanliness was assessed at baseline and one month review using: i) Denture Cleanliness Index (DCI) scores; ii) plaque coverage percentage; and (iii) microbiological tests. Results: There were significantly greater reductions in mean DCI scores and mean percentage of plaque coverage area in group 1 and group 2 compared to the control group for both CoCr and acrylic fitting surfaces (p<0.001). Group 1 had significant reductions in the viable counts of bacteria (CoCr and acrylic) and yeast (CoCr only) (p<0.05), while only significant reductions in bacterial viable counts (CoCr and acrylic) (p<0.05) were documented in Group 2. No significant differences were detected between groups 1 and 2 with regards to all clinical and microbiological outcomes. When comparing these parameters for CoCr and acrylic surfaces, no significant differences were observed following the intervention period. Conclusions: The ultrasonic cleaner was significantly more effective than the control in the reduction of biofilm coverage on metal framework removable partial dentures during the one month intervention period. The adjunctive use of cetylpyridinium chloride with ultrasonic cleaning did not yield improved outcomes compared to water.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 20, 2017
• Est. primary completion date: June 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• previously provided with cobalt chromium metal framework removable partial dentures (RPDs) within the past five years at Prince Philip Dental Hospital

Exclusion Criteria:

Related Conditions & MeSH terms

• Cetylpyridinium Chloride
• Denture
• Denture Cleansers
• Removable Partial Denture

Intervention

Device:
• Ultrasonic cleaning
Ultrasonic cleaning (frequency 42kHz) (for 7 minutes 30 seconds) with cetylpyridinium chloride
• Ultrasonic cleaning
Ultrasonic cleaning (frequency 42kHz) (for 7 minutes 30 seconds) with water

Other:
• Conventional denture hygiene
Mechanical cleaning of denture with a soft toothbrush and liquid detergent

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Denture hygiene (visual assessment)	Denture Cleanliness Index (visual assessment)	one month
Secondary	Denture hygiene (planimetric assessment)	Quantitative analysis of denture cleanliness was determined by obtaining photographic images and planimetric assessment	one month
Secondary	Gram negative bacilli	Viable counts of aerobic and facultatively anaerobic bacteria	one month
Secondary	Yeasts	Viable counts of yeasts	one month
Secondary	Staphylococcus aureus	Viable counts of Staphylococcus aureus	one month