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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03522272
Recruitment Status : Completed
First Posted : May 11, 2018
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Otto Lok-Tao Lam, 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.

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

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Study Type : Interventional  (Clinical Trial)
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 : June 20, 2016
Actual Primary Completion Date : June 20, 2017
Actual Study Completion Date : June 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures

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




Primary Outcome Measures :
  1. Denture hygiene (visual assessment) [ Time Frame: one month ]
    Denture Cleanliness Index (visual assessment)


Secondary Outcome Measures :
  1. Denture hygiene (planimetric assessment) [ Time Frame: one month ]
    Quantitative analysis of denture cleanliness was determined by obtaining photographic images and planimetric assessment

  2. Gram negative bacilli [ Time Frame: one month ]
    Viable counts of aerobic and facultatively anaerobic bacteria

  3. Yeasts [ Time Frame: one month ]
    Viable counts of yeasts

  4. Staphylococcus aureus [ Time Frame: one month ]
    Viable counts of Staphylococcus aureus



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

-

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Responsible Party: Dr. Otto Lok-Tao Lam, Clinical assistant professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03522272    
Other Study ID Numbers: UW16-266
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Otto Lok-Tao Lam, The University of Hong Kong:
denture
removable partial denture
denture cleansers
ultrasonics
cetylpyridinium chloride
Staphylococcus aureus
Gram negative bacilli
Candida
yeast