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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03522272
Enrollment
66
Registered
2018-05-11
Start date
2016-06-20
Completion date
2017-06-20
Last updated
2018-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cetylpyridinium Chloride, Denture, Denture Cleansers, Removable Partial Denture

Keywords

denture, removable partial denture, denture cleansers, ultrasonics, cetylpyridinium chloride, Staphylococcus aureus, Gram negative bacilli, Candida, yeast

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.

Interventions

DEVICEUltrasonic cleaning

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

OTHERConventional denture hygiene

Mechanical cleaning of denture with a soft toothbrush and liquid detergent

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Denture hygiene (visual assessment)one monthDenture Cleanliness Index (visual assessment)

Secondary

MeasureTime frameDescription
Denture hygiene (planimetric assessment)one monthQuantitative analysis of denture cleanliness was determined by obtaining photographic images and planimetric assessment
Gram negative bacillione monthViable counts of aerobic and facultatively anaerobic bacteria
Yeastsone monthViable counts of yeasts
Staphylococcus aureusone monthViable counts of Staphylococcus aureus

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026