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

Phase 4

Completed

• Conditions: Denture; Denture Cleansers; Removable Partial Denture; Cetylpyridinium Chloride
• Interventions: Device: Ultrasonic cleaning; Other: Conventional denture hygiene

• Registration Number: NCT03522272
• Lead Sponsor: The University of Hong Kong

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-06-20
• Primary Completion: 2017-06-20
• Study Completion: 2017-06-20
• Status Verified: 2018-04
• Study First Submitted: 2018-04-30
• Study First Submitted QC: 2018-04-30
• Last Update Submitted: 2018-04-30
• Study First Posted: 2018-05-11
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

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

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasonic cleaning with cetylpyridinium chloride	Ultrasonic cleaning	Mechanical cleaning of the RPD with a soft toothbrush and liquid detergent, and ultrasonic cleaning (frequency 42kHz) (for 7 minutes 30 seconds) of the denture with 0.07% cetylpyridinium chloride mouthrinse
Ultrasonic cleaning with water	Ultrasonic cleaning	Mechanical cleaning of the RPD with a soft toothbrush and liquid detergent, and ultrasonic cleaning (frequency 42kHz) (for 7 minutes 30 seconds) of the denture with distilled water
Conventional denture hygiene	Conventional denture hygiene	Mechanical cleaning of the RPD with a soft toothbrush and liquid detergent (Control group)

Primary Outcome Measures

Name	Time	Method
Denture hygiene (visual assessment)	one month	Denture Cleanliness Index (visual assessment)

Secondary Outcome Measures

Name	Time	Method
Denture hygiene (planimetric assessment)	one month	Quantitative analysis of denture cleanliness was determined by obtaining photographic images and planimetric assessment
Gram negative bacilli	one month	Viable counts of aerobic and facultatively anaerobic bacteria
Yeasts	one month	Viable counts of yeasts
Staphylococcus aureus	one month	Viable counts of Staphylococcus aureus