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

Sponsor

The University of Hong Kong (Other)

Overall Status

Completed

CT.gov ID

NCT03522272

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Denture Removable Partial Denture Denture Cleansers Cetylpyridinium Chloride	Device: Ultrasonic cleaning Device: Ultrasonic cleaning Other: Conventional denture hygiene	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 20, 2016

Actual Primary Completion Date :

Jun 20, 2017

Actual Study Completion Date :

Jun 20, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Ultrasonic cleaning with cetylpyridinium chloride

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

Ultrasonic cleaning (frequency 42kHz) (for 7 minutes 30 seconds) with cetylpyridinium chloride

Active Comparator: Ultrasonic cleaning with water

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

Ultrasonic cleaning (frequency 42kHz) (for 7 minutes 30 seconds) with water

Active Comparator: Conventional denture hygiene

Mechanical cleaning of the RPD with a soft toothbrush and liquid detergent (Control group)

Other: Conventional denture hygiene

Mechanical cleaning of denture with a soft toothbrush and liquid detergent

Outcome Measures

Primary Outcome Measures

Denture hygiene (visual assessment) [one month]
Denture Cleanliness Index (visual assessment)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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