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

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.

Study Overview

• Status: Completed
• Conditions: Denture; Cetylpyridinium Chloride; Removable Partial Denture; Denture Cleansers
• Intervention / Treatment: Device: Ultrasonic cleaning; Device: Ultrasonic cleaning; Other: Conventional denture hygiene

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / 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; Device: Ultrasonic cleaning; Ultrasonic cleaning (frequency 42kHz) (for 7 minutes 30 seconds) with water
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 cetylpyridinium chloride; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 20, 2016
• Primary Completion (ACTUAL): June 20, 2017
• Study Completion (ACTUAL): June 20, 2017

Study Registration Dates

• First Submitted: April 30, 2018
• First Submitted That Met QC Criteria: April 30, 2018
• First Posted (ACTUAL): May 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Staphylococcus aureus; Candida; denture; removable partial denture; cetylpyridinium chloride; yeast; ultrasonics; denture cleansers; Gram negative bacilli
• Other Study ID Numbers: UW16-266

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No