The Efficacy of Integrated Siwak Practice (SMILE) Module on Short-term Periodontal Clinical Outcome, Compliance, and Acceptance.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 4
- 主要终点
- Change in Plaque Index (PI)
研究概览
简要总结
This multicentre randomised controlled trial aims to evaluate the efficacy and safety of the SMILETM (Siwak Method for Integrated Lifestyle Enhancement) module in improving short-term periodontal outcomes, oral hygiene behaviour, and safe siwak practice among clinical dental students. Conventional toothbrushing will serve as the control intervention.
Eligible participants will be randomly assigned to either the SMILE intervention group or the conventional toothbrushing control group. Both groups will receive professional oral prophylaxis, standardised oral hygiene education, structured training according to their allocated intervention, and digital monitoring throughout the 21-day study period.
The study will assess changes in plaque accumulation, gingival health, and bleeding on probing, as well as participant compliance, behavioural outcomes, acceptability of the SMILE module, and intervention-related adverse events.
It is hypothesised that the SMILE module will effectively improve short-term periodontal outcomes, promote better compliance with the recommended oral hygiene practice, and achieve favourable acceptability while maintaining participant safety.
详细描述
The participants will be recruited from four Malaysian universities and two Indonesian universities. Individuals who meet the eligibility criteria and provide written informed consent will undergo screening, oral examination, professional oral prophylaxis and any necessary dental treatment to establish a comparable baseline oral condition prior to randomisation.
Participants will then be randomly assigned in a 1:1 ratio to either the SMILE intervention group or the conventional toothbrushing control group using a computer-generated stratified randomisation sequence. Allocation concealment will be maintained through a centralised electronic allocation system. Outcome assessors and data analysts will remain blinded to group allocation.
The SMILE intervention group will receive a structured behavioural module delivered through the SMILE mobile application. The programme includes standardised instruction on siwak preparation, brushing technique, storage, recommended frequency of use, instructional videos, supervised hands-on practice, a standardised siwak kit, and daily monitoring using the mobile application with a paper logbook available as a contingency.
Participants in the control group will receive a structured conventional toothbrushing module following the same training schedule and monitoring procedures. A standardised toothbrush kit and the study application containing toothbrushing educational materials will be provided to ensure equivalent participant support and follow-up throughout the study.
Following completion of training, participants will perform their allocated oral hygiene practice for 21 consecutive days. Adherence to the assigned intervention will be monitored using the study application or the paper logbook when required. Clinical assessments will be conducted at baseline and at Day 21 by calibrated examiners using standardised periodontal examination procedures. The study is designed to determine the efficacy of the SMILE module under controlled conditions using conventional toothbrushing as the active control intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the behavioural intervention, participants, care providers, and investigators cannot be blinded to group allocation. However, outcome assessors responsible for the clinical examinations will remain blinded to treatment allocation. The examiners will not be involved in participant training or intervention delivery, and participants will be instructed not to disclose their allocated intervention during clinical assessments. Statistical analyses will be performed using anonymised datasets with coded treatment groups by an independent data analyst who will remain blinded to treatment allocation until completion of the primary analyses.
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 - 24 years
- •Clinical dental students enrolled at one of the participating universities.
- •Participants with a maximum diagnosed with plaque-induced gingivitis according to the 2018 Classification of Periodontal and Peri-Implant Diseases and Conditions, without clinical attachment loss attributable to periodontitis.
- •Have adequate oral hygiene (ranging from good to fair; score from 0 to 1.9 according to Silness and Löe plaque index (1964)
- •Possess at least 28 natural teeth.
- •Able to understand study procedures and provide written informed consent.
- •Willing to comply with all study procedures, intervention instructions, and follow-up assessments.
排除标准
- •Using braces and dental prosthesis.
- •Presence of systemic diseases known to influence oral and periodontal health
- •Use of antibiotics for the last 3 months or any medication or known to affect oral and periodontal tissues or salivary flow
- •Moderate or high dental caries risk
- •Severe tooth malposition that may interfere with plaque assessment or oral hygiene procedures
- •Participants presenting with moderate - severe dentin hypersensitivity
- •Participants with mucosa/ gingival trauma/recession and tooth wear
- •Pregnancy or breastfeeding
- •History of allergy or hypersensitivity to any material used in the study
- •Cognitive, psychiatric, or physical conditions that may impair compliance with study procedures
研究组 & 干预措施
SMILE Intervention Group
Participants assigned to this group will receive the SMILE module behavioural intervention. The intervention includes standardised training in integrated siwak practice delivered through a mobile application, supervised hands-on practice, a standardised siwak kit, daily compliance monitoring, and supporting educational materials. Participants will perform integrated siwak practice according to the standardised protocol for 21 consecutive days.
干预措施: SMILE Module (Behavioral)
Conventional Toothbrushing Control Group
Participants assigned to this group will receive standardised oral hygiene education based on conventional toothbrushing. They will undergo the same recruitment procedures, oral examination, prophylaxis, training duration, monitoring schedule, follow-up assessments, and data collection procedures as the intervention group.
干预措施: Conventional Toothbrushing Module (Behavioral)
结局指标
主要结局
Change in Plaque Index (PI)
时间窗: Baseline (day 0) and day 21 after randomisation
Plaque accumulation will be assessed using the Silness and Löe Plaque Index (1964), which evaluates the amount of plaque present at the gingival margin on four tooth surfaces using a 0-3 ordinal scale. Lower scores indicate better plaque control.
次要结局
- Change in Gingival Index (GI)(Baseline (day 0) and day 21 after randomisation)
研究者
Nik Madihah Nik Aziz
Lecturer and Clinical Specialist in Periodontology, Principal Investigator
National University of Malaysia