A Randomized Clinical Trial on the Effect of a Chlorine Dioxide Spray on Dental Plaque and Respiratory Pathogens in Institutionalized Elders
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 228
- 主要终点
- Change in dental plaque
研究概览
简要总结
The primary objective of this 6 month study is to compare the effectiveness of oral health promotion interventions on both clinical oral health, and oral opportunistic respiratory pathogens in institutionalized elders. Secondary objectives are to investigate changes in oral health-related quality of life, incidence of adverse side effects, pneumonia, as well as subject acceptability.
Elders residing in nursing homes in Hong Kong will be recruited into the clinical trial. Patients will be randomly allocated into one of the following groups: 0.2% chlorhexidine spray, 0.1% pH-balanced chlorine dioxide spray, or sterile water spray (placebo control), once daily. Dental plaque, gingival bleeding, oral opportunistic respiratory pathogens, oral health-related quality of life (OHRQoL), and pneumonia incidence will be assessed at baseline, 3 months and 6 months. Subject acceptability of the interventions will be assessed at the end of the clinical trial.
详细描述
STUDY SITE AND PARTICIPANTS This study will be a randomized, double-blind, parallel-group clinical trial of 6 months duration. The study was approved by the Institutional Review Board of the University of Hong Kong (IRB reference number: UW 12-509) (Appendix II). A clinical trial certificate (No. 100269) was obtained from the Department of Health, Hong Kong.
The inclusion criteria for recruiting patients in this randomized clinical trial (RCT) are: (1) age 65 years and above; (2) not less than six natural teeth in the mouth; (3) not having an indwelling naso-gastric feeding tube.
SAMPLE SIZE CALCULATION Dental plaque will be the primary outcome variable in this study. A previous study conducted amongst institutionalized elders in Hong Kong documented a mean PI score of 2.0 (standard deviation [SD] =0.7) (Lo et al. 2005). Thus, based on 80% power and a statistical significance level set at 0.05, 61 participants in each group are required in order to detect a difference in PI scores of at least 0.4 between the three treatment groups. In order to account for an anticipated 25% dropout rate, the proposed sample size is 76 patients per group (228 in total).
SUBJECT RECRUITMENT An invitation letter will be sent to residential care homes informing that the dental hospital would like to provide oral health activities for elders at their care homes. Written informed consent will be obtained from all subjects who opt to participate before the commencement of the study.
STUDY PROCEDURE A one-hour oral health presentation covering oral health care and common oral diseases, as well as oral hygiene demonstrations and practical exercises encompassing proper techniques for assisting residents with toothbrushing, denture cleaning, and clearance of remaining food debris in the oral cavity following meals, will be provided by a registered dentist to the nursing home staff and residents. In addition, hand-over-hand demonstrations on how to use the oral spray, and the specific areas of the oral cavity to be sprayed will be performed on a tooth block model. Caregivers will apply a daily dose of 12 sprays (each delivering a volume of 0.13ml) to the buccal and lingual gingival third of tooth surfaces in each sextant.
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
- Quadruple (Participant, Care Provider, 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
- 否
入选标准
- •not less than six natural teeth
- •not having an indwelling nasogastric tube
排除标准
- 未提供
研究组 & 干预措施
Sterile water spray
Placebo
干预措施: Oral spray (chlorhexidine spray, chlorine dioxide spray, sterile water spray) (Other)
Chlorhexidine spray
0.2% chlorhexidine oral spray, once daily
干预措施: Oral spray (chlorhexidine spray, chlorine dioxide spray, sterile water spray) (Other)
Chlorine Dioxide spray
0.1% pH-balanced chlorine dioxide oral spray, once daily
干预措施: Oral spray (chlorhexidine spray, chlorine dioxide spray, sterile water spray) (Other)
结局指标
主要结局
Change in dental plaque
时间窗: baseline to 6 months
Change in dental plaque (Silness and Löe Plaque Index) from baseline to 3 months and 6 months
次要结局
- Change in gingival bleeding(baseline to 6 months)
- Change in oral health-related quality of life(baseline to 6 months)
- Aspiration pneumonia(over 6 months)
- Side effects(Baseline to 6 months)
- Change in Staphylococcus aureus(Baseline to 6 months)
- Change in aerobic and facultative anaerobic Gram-negative bacilli(Baseline to 6 months)
- Change in Moraxella catarrhalis(Baseline to 6 months)
- Change in Streptococcus pneumoniae(Baseline to 6 months)
- Change in Haemophilus influenzae(Baseline to 6 months)
研究者
Dr. Otto Lok-Tao Lam
Clinical assistant professor
The University of Hong Kong