[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628986":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":44,"locations":51,"responsibleParty":70,"collaborators":49,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":49,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":81,"maxAge":49,"enrollmentInfo":82,"targetDuration":49,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":98,"whyStopped":49,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Gulf Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"iTOP Oral Hygiene Training with Calibrated Interdental Brushes","EXPERIMENTAL","Experimental",[13],"Behavioral: Individually Trained Oral Prophylaxis (iTOP) Oral Hygiene Training",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional Oral Hygiene Instruction","ACTIVE_COMPARATOR","Participants receive conventional oral hygiene education through model demonstration and video-based instruction. The session includes verbal explanation of toothbrushing and interdental cleaning techniques without individualized hands-on training. Reinforcement sessions are conducted at 2 weeks, 1 month, and 3 months.",[19],"Behavioral: Conventional Oral Hygiene Instruction",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Individually Trained Oral Prophylaxis (iTOP) Oral Hygiene Training","Participants receive individualized oral hygiene training using the Individually Trained Oral Prophylaxis (iTOP) method. The intervention is delivered in a one-to-one chairside session and uses the Touch-to-Teach technique, where the clinician guides the participant's hand to demonstrate correct toothbrushing and interdental cleaning movements. Calibrated interdental brushes are selected based on individual interdental space measurements using a color-coded interdental access probe. Participants practice the technique under supervision until proper technique is achieved. Reinforcement sessions are provided at 2 weeks, 1 month, and 3 months to ensure adherence and correct oral hygiene performance.",[9],[27,28],"Touch-to-Teach Technique","Personalized",{"type":22,"name":15,"description":30,"armGroupLabels":31,"otherNames":32},"Participants receive conventional oral hygiene education consisting of verbal explanation, model demonstration, and video-based instruction illustrating standard toothbrushing and interdental cleaning techniques. This educational approach provides visual and verbal guidance but does not include individualized calibration of interdental brushes or hands-on correction of brushing technique. Participants are instructed to brush twice daily and perform interdental cleaning once daily using the provided oral hygiene kit. Reinforcement sessions using the same demonstration and video-based instruction are conducted at 2 weeks, 1 month, and 3 months.",[15],[33],"Model Demonstration and Video-Based Oral Hygiene Education",[35,38,41],{"name":36,"affiliation":5,"role":37},"Mohamed Atef Sayed","STUDY_CHAIR",{"name":39,"affiliation":5,"role":40},"Fatema Ramadhan, M.D.S","PRINCIPAL_INVESTIGATOR",{"name":42,"affiliation":5,"role":43},"Bhavna Kurkeja, Ph.D.","STUDY_DIRECTOR",[45],{"name":46,"role":47,"phone":48,"phoneExt":49,"email":50},"Mohamed Atef Sayed, Ph.D","CONTACT","+971581069908",null,"dr.mohamedatef@gmu.ac.ae",[52],{"facility":5,"status":49,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Ajman","Ajman Emirate","4184","United Arab Emirates","AE",{"type":59,"coordinates":60},"Point",[61,62],55.47878,25.40177,{"lat":62,"lon":61},[65,67,68],{"name":66,"role":47,"phone":48,"phoneExt":49,"email":50},"Mohamed Atef Sayed, Ph.D.",{"name":39,"role":40,"phone":49,"phoneExt":49,"email":49},{"name":66,"role":69,"phone":49,"phoneExt":49,"email":49},"SUB_INVESTIGATOR",{"type":71,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100628986","effect-of-individually-trained-oral-prophylaxis-itop-on-gingival-health-in-orthodontic-patients-100628986",false,"NCT07468773","Effect of Individually Trained Oral Prophylaxis (iTOP) on Gingival Health in Orthodontic Patients","Effect of Individually Trained Oral Prophylaxis (iTOP) Versus Conventional Oral Hygiene Instruction on Gingival Health in Orthodontic Patients Using Calibrated Interdental Brushes: A Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n1. Adults aged 18 years or older\n2. Patients undergoing fixed orthodontic treatment\n3. Diagnosis of biofilm-induced gingivitis\n4. Presence of interdental spaces suitable for calibrated interdental brush use\n5. Ability and willingness to perform oral hygiene procedures and attend follow-up visits\n6. Provision of written informed consent\n\nExclusion Criteria:\n\n1. Presence of systemic diseases affecting gingival health (e.g., uncontrolled diabetes)\n2. Use of medications known to influence gingival conditions (e.g., phenytoin, cyclosporine, calcium channel blockers)\n3. History of chemotherapy or radiotherapy in the head and neck region\n4. Current smokers\n5. Pregnant or lactating women\n6. Patients with physical or cognitive disabilities affecting oral hygiene performance\n7. Use of additional professional oral hygiene interventions or antimicrobial mouth rinses during the study period",true,"ALL","18 Years",{"count":83,"type":84},60,"ESTIMATED","INTERVENTIONAL",[87],"NA","This randomized controlled clinical trial aims to evaluate the effectiveness of individualized oral hygiene education using the Individually Trained Oral Prophylaxis (iTOP) method compared with conventional oral hygiene instruction using model demonstration and video-based education in orthodontic patients diagnosed with gingivitis.\n\nSixty orthodontic patients underwent professional mechanical plaque removal and received oral hygiene instruction using calibrated interdental brushes. Participants were randomly assigned to either the iTOP training group or the conventional education group.\n\nClinical outcomes including Approximal Plaque Index (API), Gingival Index (GI), and Full Mouth Bleeding Score (FMBS) were assessed at baseline and after three months to determine the effectiveness of the educational interventions on plaque control and gingival health.",[90,91],"Gingivitis","Orthodontic Treatment",[93,94,95,96,97],"Interdental Brushes","iTOP","Oral Hygiene Education","Approximal Plaque Index","Plaque Control","NOT_YET_RECRUITING","2026-03-09",{"date":101,"type":102},"2026-03-13","ACTUAL",{"date":104,"type":84},"2026-03-30",{"date":106,"type":84},"2026-09-30",{"name":5,"class":6},1]