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临床试验/NCT03522272
NCT03522272已完成4 期

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

The University of Hong Kong0 个研究点目标入组 66 人开始时间: 2016年6月20日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
66
主要终点
Denture hygiene (visual assessment)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

研究组 & 干预措施

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

干预措施: Ultrasonic cleaning (Device)

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

干预措施: Ultrasonic cleaning (Device)

Conventional denture hygiene

Active Comparator

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

干预措施: Conventional denture hygiene (Other)

结局指标

主要结局

Denture hygiene (visual assessment)

时间窗: one month

Denture Cleanliness Index (visual assessment)

次要结局

  • Denture hygiene (planimetric assessment)(one month)
  • Gram negative bacilli(one month)
  • Yeasts(one month)
  • Staphylococcus aureus(one month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Otto Lok-Tao Lam

Clinical assistant professor

The University of Hong Kong

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