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

Study Overview
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Brief Summary
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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.

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

Conditions
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Denture Cleansers, Cetylpyridinium Chloride, Denture, Removable Partial Denture

Intervention / Treatment
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* Device: Ultrasonic cleaning
* Device: Ultrasonic cleaning
* Other: Conventional denture hygiene


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasonic cleaning with cetylpyridinium chloride<br>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 | Device: Ultrasonic cleaning<br>* Ultrasonic cleaning (frequency 42kHz) (for 7 minutes 30 seconds) with cetylpyridinium chloride<br>|
| Active Comparator: Ultrasonic cleaning with water<br>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 | Device: Ultrasonic cleaning<br>* Ultrasonic cleaning (frequency 42kHz) (for 7 minutes 30 seconds) with water<br>|
| Active Comparator: Conventional denture hygiene<br>Mechanical cleaning of the RPD with a soft toothbrush and liquid detergent (Control group) | Other: Conventional denture hygiene<br>* Mechanical cleaning of denture with a soft toothbrush and liquid detergent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Denture hygiene (visual assessment) | Denture Cleanliness Index (visual assessment) | one month | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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denture, removable partial denture, denture cleansers, ultrasonics, cetylpyridinium chloride, Staphylococcus aureus, Gram negative bacilli, Candida, yeast