The Effect of Regular Home Use of Dual-light Antibacterial Photodynamic Therapy (aPDT) or the Use of a Powered Toothbrush in Older Individuals With Periodontitis and Mild Cognitive Impairment: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- MMSE-test
研究概览
简要总结
Objective:
To compare three different oral hygiene regimens regarding plaque index (PI), bleeding on probing (BOP), the number of deepened periodontal pockets ≥4 mm (PPD), oral halitosis, and changes in oral health-related quality of life (OHRQoL) in an older population with periodontitis stage I-III and mild cognitive impairment.
- Are there improvements in plaque index (PI), number of bleeding on probing (BOP) sites, number of probing depths (PPD), and intraoral halitosis in the two test groups compared to the control group?
- Do the study interventions affect oral health-related quality of life in older adults with periodontitis and mild cognitive impairment?
Study design:
Type: Randomized controlled trial Duration: 6 months per participant, 2 years in total for data collection Participants: 90 participants divided into Intervention and Control groups
Intervention Group A (Lumoral Dual-Light aPDT + Manual Toothbrush) Standardized oral hygiene instructions and the use of a manual toothbrush during the test period, with an adjunctive aPDT device (Lumoral®).
Intervention Group B (Oral-B iO Powered Toothbrush) Standardized oral hygiene instructions and the use of an Oral-B iO powered toothbrush during the test period.
Control Group Standardized oral hygiene instructions and the use of a manual TePe Select extra soft toothbrush during the test period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥60 years
- •≥15 teeth
- •Diagnosed periodontitis stage I-III
- •MMSE score between 22-28
- •Able to provide informed consent
排除标准
- •Antibiotic use (within 3 months)
- •Lumoral use within 3 months
- •Bisphosphonate medication
- •Immunosuppressive drugs or radiation therapy
研究组 & 干预措施
Partisipants with Lumoral Dual-Light aPDT + Manual Toothbrush
干预措施: Dual-Light aPDT Treatment - Lumoral (Device)
Partisipants with Oral-B iO Powered Toothbrush
干预措施: Oral-B Powered toothbrush (Device)
Control Group
结局指标
主要结局
MMSE-test
时间窗: Baseline
An 11-item cognitive assessment covering five domains: orientation, registration, attention and calculation, recall, and language. The maximum possible score is 30, with a score of 23 or lower indicating cognitive impairment.
Change in the amount of dental plaque
时间窗: Assessments will be conducted at baseline, at 3 months, and at 6 months.
Assessment will be performed on all teeth at six sites per tooth. The plaque index (PI) will be reported as the percentage of sites with visible plaque, providing an estimate of the overall plaque accumulation on the teeth.
Change in the amount of gingival bleeding on probing
时间窗: Assessments will be conducted at baseline, at 3 months, and at 6 months.
A full-mouth assessment will be performed at six sites per tooth. Bleeding on probing (BOP) will be reported as the percentage of sites exhibiting bleeding.
Change in the number of periodontal pockets ≥4 mm in depth
时间窗: Assessments will be conducted at baseline, at 3 months, and at 6 months.
Pocket depth will be measured from the base of the pocket to the gingival margin at six sites per tooth. Probing pocket depths (PPD) of ≥4 mm will be recorded.
MMSE-test
时间窗: Baseline
An 11-item cognitive assessment covering five domains: orientation, registration, attention and calculation, recall, and language. The maximum possible score is 30, with a score of 23 or lower indicating cognitive impairment.
Change in the amount of VSCs in the exhaled air
时间窗: Assessments will be conducted at baseline, at 3 months, and at 6 months.
Volatile sulfur compounds (VSCs) in exhaled air will be measured using the OralChroma® device. The cutoff values are as follows: H₂S ≥112 ppb, CH₃SH ≥26 ppb, and (CH₃)₂S ≥8 ppb.
Change in values for the oral health related quality of life instrument OHIP-14
时间窗: Assessments will be conducted from baseline to 6 months.
Oral health-related quality of life will be assessed using the OHIP-14 (Oral Health Impact Profile-14) instrument. Scores range from 0 to 56, with lower scores indicating better oral health-related quality of life.
次要结局
未报告次要终点