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

NCT03522272 | Completed Phase 4 DMC

• 1 other identifier: UW16-266
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• Denture hygiene (visual assessment)

  Denture Cleanliness Index (visual assessment)

  one month

Secondary Outcomes (4)

• Denture hygiene (planimetric assessment)

  one month

• Gram negative bacilli

  one month

• Yeasts

  one month

• Staphylococcus aureus

  one month

Study Arms (3)

Ultrasonic cleaning with cetylpyridinium chloride

EXPERIMENTAL

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 with water

ACTIVE COMPARATOR

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

Conventional denture hygiene

ACTIVE COMPARATOR

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

Other: Conventional denture hygiene

Interventions

Ultrasonic cleaning DEVICE

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

Ultrasonic cleaning with cetylpyridinium chloride

Conventional denture hygiene OTHER

Mechanical cleaning of denture with a soft toothbrush and liquid detergent

Conventional denture hygiene

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• The University of Hong Kong: lead

MeSH Terms

Conditions

Staphylococcal Infections; Torulopsis

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical assistant professor

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: May 11, 2018
• Study Start: June 20, 2016
• Primary Completion: June 20, 2017
• Study Completion: June 20, 2017
• Last Updated: May 11, 2018

Record last verified: 2018-04