Clinical trial NCT03522272: Effectiveness of an Ultrasonic Denture Hygiene Intervention Program Among Community-dwelling Elders
Official title: Effectiveness of an Ultrasonic Denture Hygiene Intervention Program Among Community-dwelling Elders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Denture
Removable Partial Denture
Denture Cleansers
Cetylpyridinium Chloride
Keywords: denture
removable partial denture
denture cleansers
ultrasonics
cetylpyridinium chloride
Staphylococcus aureus
Gram negative bacilli
Candida
yeast
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 66
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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:

-

Primary outcomes:
measure: Denture hygiene (visual assessment)
timeFrame: one month
Secondary outcomes:
measure: Denture hygiene (planimetric assessment)
timeFrame: one month
measure: Gram negative bacilli
timeFrame: one month
measure: Yeasts
timeFrame: one month
measure: Staphylococcus aureus
timeFrame: one month
Other outcomes:
Locations:
Study officials:
References: