[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645493":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":86,"collaborators":90,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":108,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":26,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":122,"overallStatus":132,"whyStopped":26,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"National University of Malaysia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SMILE Intervention Group","EXPERIMENTAL","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.",[13],"Behavioral: SMILE Module",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional Toothbrushing Control Group","ACTIVE_COMPARATOR","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.",[19],"Behavioral: Conventional Toothbrushing Module",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","SMILE Module","The SMILE module intervention is a standardised behavioural oral hygiene programme designed to promote appropriate siwak use. The programme includes instruction on siwak preparation, brushing techniques, storage, replacement, frequency of use, and monitoring for safe siwak practice. Training is delivered through the SMILE mobile application using instructional videos and structured educational content, followed by supervised practical training.\n\nParticipants will receive a standardised siwak kit and will be instructed to perform siwak cleaning five times daily, corresponding to the recommended practice incorporated within the module. Adherence will be monitored throughout the 21-day intervention using the mobile application and\u002For daily logbook.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Conventional Toothbrushing Module","Participants will receive standardised training in conventional toothbrushing through a structured educational module delivered using the study mobile application. The programme includes instruction on toothbrush preparation, brushing techniques, brushing duration, and toothbrush replacement recommendations. Participants will receive a standardised toothbrush kit and will be instructed to brush their teeth twice daily for approximately two minutes throughout the 21-day intervention period. Compliance will be monitored using mobile application and daily logbook employed for the intervention group.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Amanah Pertiwisari, drg, M.KG","CONTACT","+60 10-5871-889","p154143@siswa.ukm.edu.my",{"name":38,"role":34,"phone":26,"phoneExt":26,"email":39},"Shahida Mohd Said, BDS, MClinDent (Periodontology","shahidams@ukm.edu.my",[41,58,66,76],{"facility":42,"status":26,"city":43,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Faculty of Dentistry, Universiti Kebangsaan Malaysia","Kuala Lumpur","50300","Malaysia","MY",{"type":48,"coordinates":49},"Point",[50,51],101.68653,3.1412,{"lat":51,"lon":50},[54],{"name":55,"role":34,"phone":56,"phoneExt":26,"email":57},"Nik Madihah Nik Azis, Dclindent Periodontology","0133410210","nikmadihah@ukm.edu.my",{"facility":59,"status":26,"city":43,"state":43,"zip":60,"country":45,"countryCode":46,"cosmosGeoPoint":61,"geoPoint":63,"contacts":64},"Faculty of Dentistry, Universiti Sains Islam Malaysia","55100",{"type":48,"coordinates":62},[50,51],{"lat":51,"lon":50},[65],{"name":26,"role":34,"phone":56,"phoneExt":26,"email":57},{"facility":67,"status":26,"city":68,"state":69,"zip":70,"country":45,"countryCode":46,"cosmosGeoPoint":71,"geoPoint":75,"contacts":26},"Kulliyyah of Dentistry, International Islamic University Malaysia","Kuantan","Pahang","25200",{"type":48,"coordinates":72},[73,74],103.326,3.8077,{"lat":74,"lon":73},{"facility":77,"status":26,"city":78,"state":79,"zip":80,"country":45,"countryCode":46,"cosmosGeoPoint":81,"geoPoint":85,"contacts":26},"Faculty of Dentistry, Universiti Teknologi MARA","Sungai Buloh","Selangor","47000",{"type":48,"coordinates":82},[83,84],101.561,3.21,{"lat":84,"lon":83},{"type":87,"investigatorFullName":88,"investigatorTitle":89,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Nik Madihah Nik Aziz","Lecturer and Clinical Specialist in Periodontology, Principal Investigator",[91,93,96,98],{"name":92,"class":6},"Universiti Sains Islam Malaysia",{"name":94,"class":95},"Universiti Teknologi MARA (UiTM) Sungai Buloh Campus, Malaysia","UNKNOWN",{"name":97,"class":6},"International Islamic University Malaysia",{"name":99,"class":6},"Hasanuddin University","100645493","a-multicentre-randomised-controlled-trial-evaluating-the-efficacy-of-the-smile-module-for-improving-short-term-periodontal-outcomes-compliance-and-acceptability-among-clinical-dental-students-100645493",false,"NCT07702383","A Multicentre Randomised Controlled Trial Evaluating the Efficacy of the SMILE™ Module for Improving Short-term Periodontal Outcomes, Compliance, and Acceptability Among Clinical Dental Students","The Efficacy of Integrated Siwak Practice (SMILE) Module on Short-term Periodontal Clinical Outcome, Compliance, and Acceptance.","SMILE","Inclusion Criteria:\n\n1. Adults aged 18 - 24 years\n2. Clinical dental students enrolled at one of the participating universities.\n3. 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.\n4. Have adequate oral hygiene (ranging from good to fair; score from 0 to 1.9 according to Silness and Löe plaque index (1964)\n5. Possess at least 28 natural teeth.\n6. Able to understand study procedures and provide written informed consent.\n7. Willing to comply with all study procedures, intervention instructions, and follow-up assessments.\n\nExclusion Criteria:\n\n1. Using braces and dental prosthesis.\n2. Presence of systemic diseases known to influence oral and periodontal health\n3. Use of antibiotics for the last 3 months or any medication or known to affect oral and periodontal tissues or salivary flow\n4. Moderate or high dental caries risk\n5. Severe tooth malposition that may interfere with plaque assessment or oral hygiene procedures\n6. Participants presenting with moderate - severe dentin hypersensitivity\n7. Participants with mucosa\u002F gingival trauma\u002Frecession and tooth wear\n8. Pregnancy or breastfeeding\n9. History of allergy or hypersensitivity to any material used in the study\n10. Cognitive, psychiatric, or physical conditions that may impair compliance with study procedures",true,"ALL","18 Years","24 Years",{"count":113,"type":114},66,"ESTIMATED","INTERVENTIONAL",[117],"NA","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.\n\nEligible 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.\n\nThe 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.\n\nIt 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.",[120,121],"Gingivitis","Gingivitis; Chronic",[123,124,125,126,127,128,129,130,131],"salvadora persica","siwak","miswak","Behavioural intervention","Randomised controlled trial,","oral hygiene","gingivitis","prevention","periodontal health","NOT_YET_RECRUITING","2026-07-13",{"date":135,"type":136},"2026-07-15","ACTUAL",{"date":138,"type":114},"2026-09-01",{"date":140,"type":114},"2027-05-31",{"name":5,"class":6},4]