[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648156":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":61,"collaborators":26,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":26,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":26,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":88,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"University of Malaya","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Two-step Angulation with Partial Unwinding Technique","EXPERIMENTAL","This is a split-mouth randomized clinical trial design where each participant serves as their own internal control. This arm represents the specific jaw quadrants randomized to receive Temporary Anchorage Device (TAD) insertion using a two-step angulation with a partial unwinding technique. The TAD is first placed parallel to the occlusal plane to create a cortical bone indentation (guided by a rubber depth stopper based on CBCT bone thickness), partially backed out (derotated) by half a turn, and subsequently reangulated to a final seating angle of 30-45 degree relative to the occlusal plane between the second premolar and first permanent molar.",[13,14],"Device: Temporary Anchorage Device (TAD)","Device: Two-step Angulation with Partial Unwinding Technique",{"label":16,"type":17,"description":18,"interventionNames":19},"Steady Oblique Angulation Technique","ACTIVE_COMPARATOR","This is a split-mouth randomized clinical trial design where each participant serves as their own internal control. This arm represents the specific jaw quadrants randomized to receive Temporary Anchorage Device (TAD) insertion via a single-step, steady oblique angulation approach. The screw is inserted directly into the alveolar bone at a constant angle of 30 to 45 degree relative to the occlusal plane, targeted anatomically between the second premolar and first permanent molar.",[13,14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Temporary Anchorage Device (TAD)","The TAD (1.6 mm diameter X 6 mm length; J2, Dual-Top Anchor System, Jeil Medical, Seoul, Korea) will be inserted directly against cortical bone surface at 30-45° to the occlusal plane, targeted anatomically between second premolar and first permanent molar. The device will be manually driven into the alveolar bone using a manual torque driver calibrated to a 10 Ncm torque value",[16,9],null,{"type":22,"name":9,"description":28,"armGroupLabels":29,"otherNames":26},"* The TAD (1.6 mm diameter X 6 mm length; J2, Dual-Top Anchor System, Jeil Medical, Seoul, Korea) is initially placed against cortical bone surface parallel to the occlusal plane between second premolar and first permanent molar to create an initial osseous indentation.\n* A slitted rubber stopper will be used to mark the depth of the TAD tip penetration through the cortical bone, predetermined via CBCT assessment of local cortical bone thickness.\n* The TAD will undergo partial derotation (unwinding) by half the total number of initial insertion turns to slightly back the device away from the cortical bone.\n* The TADs will then be reangulated to an oblique path of 30-45° relative to the occlusal plane before completing final seating between second premolar and first permanent molar",[16,9],[31],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Wan Ying Lee, Master of Oral Science","CONTACT","014-8416384","17125177@siswa.um.edu.my",[37],{"facility":38,"status":26,"city":39,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Faculty of Dentistry, Universiti Malaya","Kuala Lumpur","50603","Malaysia","MY",{"type":44,"coordinates":45},"Point",[46,47],101.68653,3.1412,{"lat":47,"lon":46},[50,51,54,57,59],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},{"name":52,"role":53,"phone":26,"phoneExt":26,"email":26},"Saritha Sivarajan","PRINCIPAL_INVESTIGATOR",{"name":55,"role":56,"phone":26,"phoneExt":26,"email":26},"Siti Adibah Othman","SUB_INVESTIGATOR",{"name":58,"role":56,"phone":26,"phoneExt":26,"email":26},"Maziahtul Zawani Munshi",{"name":60,"role":53,"phone":26,"phoneExt":26,"email":26},"Wan Ying Lee",{"type":62,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100648156","survival-success-stability-and-patient-comfort-of-tads-placed-by-steady-oblique-angled-versus-two-step-angulation-insertion-techniques-100648156",false,"NCT07715851","Survival, Success, Stability, and Patient Comfort of TADs Placed by Steady Oblique-Angled Versus Two-Step Angulation Insertion Techniques","Survival, Success, Stability, and Patient Comfort of Temporary Anchorage Devices Placed by Steady Oblique-Angled Versus Two-Step Angulation Insertion Techniques: A Split-Mouth Randomised Clinical Trial","Inclusion Criteria:\n\n* Age range: 18 years old and above\n* Bimaxillary proclination with maximum anchorage control with TAD in maxilla and mandible\n* Extraction of all four permanent first premolar as part of orthodontic treatment\n* Crowding in the upper and lower incisors (\\\u003C 5.0mm)\n* Overjet less than 6mm\n* BPE score 0, 1 or 2\n* Average vertical facial proportions\n\nExclusion Criteria:\n\n* Systemic diseases such as diabetes, osteoporosis\n* On long term use of antibiotics, phenytoin, cyclosporin, anti-inflammatory drugs, systemic corticosteroid and calcium channel blockers that would affect the bone biology\n* Cigarette smoking, vaping, history of smoking\n* Impacted \u002F missing teeth at the treatment site\n* BPE score 3 and 4\n* Vertical skeletal discrepancies e.g. high angle and low angle.\n* Orthognathic treatment need\n* Craniofacial disorder, cleft lip and palate, syndromes\n* Low maxillary sinus level with alveolar crest height of less than 4mm\n* Titanium allergy\n* Pregnant woman","ALL","18 Years",{"count":73,"type":74},28,"ESTIMATED","INTERVENTIONAL",[77],"NA","The goal of this clinical trial is to learn if two-step angulation Temporary Anchorage Devices (TADs) insertion technique better for survival, stability and patient-reported outcomes. It will also learn about how the trabecular bone volume fraction measured from pre-treatment CBCT imaging influences the stability, survival, and overall clinical success of TADs. The clinical trial will be carried out among fit and healthy adults aged 18 years old above who require extraction of all four permanent first premolars, planned for maximum anchorage using bilateral maxillary and mandibular TADs.\n\nThe main questions it aims to answer are:\n\nIn orthodontic patients,\n\n* does the two-step angulation insertion technique for TADs provide superior survival, stability, and patient-reported outcomes, with acceptable complication rates?\n* how are these outcomes influenced by maxillary and mandibular trabecular bone volume fraction measured on CBCT?\n\nResearchers will compare two-step angulation insertion technique to steady oblique-angled TADs insertion technique to see it provide more superior survival, stability, and patient-reported outcomes, with acceptable complication rates.\n\nParticipants will:\n\n* be taken CBCT radiography before TADs insertion\n* receive both TADs insertion technique either right or left on both maxilla and mandible between second premolars and first molars\n* fill up patient reported outcome questionnaire At immediate post-insertion (T0), post alignment (T1), and subsequently at monthly intervals during en-masse retraction: 1 month (T2), 2 months (T3), 3 months (T4), 4 months (T5), 5 months (T6), 6 months (T7)\n* visit the clinic for measurement of TADs stability, clinical assessment of inflammation, mobility and the need for replacement at immediate post-insertion (T0), post alignment (T1), and subsequently at monthly intervals during en-masse retraction: 1 month (T2), 2 months (T3), 3 months (T4), 4 months (T5), 5 months (T6), 6 months (T7)",[80,81],"Bimaxillary Proclination","Bimaxillary Protrusion",[83,84,81,85,86,87],"miniscrew","Temporary Anchorage Device","Stability","Survival","Patient-reported outcome","NOT_YET_RECRUITING","2026-07-14",{"date":91,"type":92},"2026-07-21","ACTUAL",{"date":94,"type":74},"2026-08-01",{"date":96,"type":74},"2028-07-31",{"name":5,"class":6},1]