[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Riyadh Elm University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":192},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,47,74,112,135,163],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100623533","salivary-flow-ph-and-buffering-capacity-in-fixed-and-clear-aligner-orthodontic-treatment-100623533",false,"NCT07397871","Salivary Flow, pH, and Buffering Capacity in Fixed and Clear Aligner Orthodontic Treatment","Changes in Salivary Parameters in Patients Undergoing Clear Aligner Orthodontic Treatment: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Class I, II and III skeletal malocclusion.\n* Age ≥18 undergoing fixed or Clear aligner orthodontic treatment.\n\nExclusion Criteria:\n\n* Current medications including antibiotic use within the past 3 months that affect salivary flow and composition.\n* Active smoking including vaping and E-cigarette use.\n* Diagnosis of systemic diseases\u002Fconditions such as Sjogren's syndrome, diabetes, chronic kidney diseases, neurological conditions.\n* Active dental caries or signs of gingivitis and\u002For periodontitis\n* Less than three months of orthodontic treatment since it is characterized by acute, temporary changes and patient adaptation to the new appliances.\n* Requiring single arch treatment to standardize the research and eliminate a potential confounding variable\n* Crown restoration is excluded due to their material properties which may affect salivary composition.\n* Pregnancy due to the physiological variation in salivary flow and composition due to hormonal changes.\n* Presence of mouth breathing may lead to inconsistent salivary flow rate, Changes in Salivary Composition and pH\n* Poor oral hygiene with high levels of dental plaque, calculus, and gingival inflammation can independently alter salivary flow rate, pH, and buffer capacity there by acting as confounding variable.","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"NA","Study Design: A randomized controlled trial with two parallel arms and an allocation ratio of 1:1.\n\nSetting: The study will be conducted in the orthodontic department of Riyadh Elm University hospitals in Riyadh City, Saudi Arabia.\n\nParticipants: Patients undergoing fixed or clear aligner orthodontic treatment referred to REU dental hospital will be randomly allocated to either the clear aligner group or the fixed orthodontic appliance group.\n\nIntervention: Prior to orthodontic treatment, all patients will receive phase I periodontal therapy and oral hygiene instructions. Fixed orthodontic appliances will be bonded using metallic brackets with a 0.022-inch slot and 0.014-inch NiTi archwires. Clear aligner patients will receive Invisalign® treatment.\n\nOutcomes and Saliva Collection: Salivary samples will be collected using the spitting method at baseline (T0) and follow-up time points according to the study protocol. Salivary flow rate, pH, and buffering capacity will be assessed as described in the proposal.\n\nRandomization and Blinding: Randomization will be performed using a random number generator with allocation concealment via opaque envelopes. The investigators involved in outcome assessment and data analysis will be blinded.\n\nEthical Considerations: The study will be submitted to the Institutional Review Board at Riyadh Elm University and conducted in accordance with IRB policies.",[26,27],"Orthodontic Treatment","Saliva",[29,30,31,32,33],"Salivary flow","Salivary pH","Buffering capacity","Fixed orthodontic appliance","Clear aligner therapy","NOT_YET_RECRUITING","2026-02-02",{"date":37,"type":38},"2026-02-09","ACTUAL",{"date":40,"type":20},"2026-03-15",{"date":42,"type":20},"2027-05-29",{"name":44,"class":45},"Riyadh Elm University","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":46},"100621992","accuracy-and-periodontal-outcomes-of-three-interproximal-enamel-reduction-techniques-during-clear-aligner-therapy-100621992","NCT07377825","Accuracy and Periodontal Outcomes of Three Interproximal Enamel Reduction Techniques During Clear Aligner Therapy","Accuracy and Periodontal Outcomes of Three Interproximal Enamel Reduction Techniques During Clear Aligner Therapy: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 18 years or older with full permanent dentition.\n* Undergoing clear aligner therapy (Invisalign) with a ClinCheck treatment plan that includes interproximal enamel reduction (IPR).\n* Periodontally healthy at baseline (per clinic screening).\n\nExclusion Criteria:\n\n* Orthodontic treatment plan including extractions.\n* Proximal restorations or caries on any tooth surface targeted for IPR.\n* Current smoking.\n* Diabetes mellitus or other systemic diseases known to affect periodontal status.",{"count":55,"type":20},75,[23],"This randomized controlled clinical trial will compare three commonly used interproximal enamel reduction (IPR) techniques during clear aligner therapy in adult patients. IPR is a routine orthodontic procedure in which a small amount of enamel is removed between teeth to create space and help achieve the planned alignment.\n\nSeventy-five adults (18 years and older) indicated for receiving clear aligner treatment with IPR prescribed in their digital treatment plan will be enrolled at the orthodontic clinics of Riyadh Elm University (Riyadh, Saudi Arabia) and randomized in a 1:1:1 ratio to one of three IPR techniques: manual abrasive strips (manual arm), motor-driven oscillating strips (motor-driven arm), or abrasive discs (abrasive arm). IPR will be performed by the same trained operator according to the assigned technique.\n\nThe primary outcome is IPR accuracy, defined as the difference between the amount of IPR planned digitally and the amount performed clinically, measured using intraoral scans taken before and immediately after IPR. Secondary outcomes are short-term periodontal outcomes, assessed on IPR teeth only using plaque and gingival bleeding indices at baseline and at a 6-week follow-up visit. The data analyst will be blinded to group allocation",[59,60,61],"Dental Crowding,Interproximal Enamel Reduction","Malocclusion, Angle's Class","Periodontal Diseases",[63,64,65],"Clear Aligner Therapy","Periodontal Disease","Interproximal Enamel Reduction","2026-01-22",{"date":68,"type":38},"2026-01-30",{"date":70,"type":20},"2026-03",{"date":72,"type":20},"2026-11",{"name":44,"class":45},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":46},"100616600","clear-aligner-cleaning-brushing-chlorhexidine-and-bluem-effects-on-oral-microbial-ecology-and-periodontal-indices-100616600","NCT07307716","Clear Aligner Cleaning: Brushing, Chlorhexidine, and BlueM Effects on Oral Microbial Ecology and Periodontal Indices","Investigating the Impact of Cleaning Protocols on Oral Microbial Ecology and Early Dysbiosis Markers on Orthodontic Clear Aligner Patients: A Randomized Cross-over Clinical Study","Inclusion Criteria:\n\n* Adults (≥18 years).\n* Undergoing or scheduled for treatment with clear aligners (CA).\n* Presence of upper and lower first molars and central incisors.\n* Periodontal health at baseline (no sites with PD ≥ 4 mm; no clinical attachment loss at index teeth; BI\u002FPI within normal limits).\n* No periodontal therapy within the previous 6 months.\n* Able and willing to comply with study instructions and follow-up visits; signed informed consent.\n* Sufficient remaining CA treatment (clinician-estimated): ≥ 14 weeks to safely cover three 1 month protocol periods plus washouts.\n\nMinimum planned aligners remaining: ≥ 11 aligners (assuming 10 days\u002Faligner) or equivalent continuous CA duration per treating orthodontist.\n\nExclusion Criteria:\n\n* Patients requiring orthognathic surgery\n* Uncontrolled systemic diseases (e.g., uncontrolled diabetes mellitus, autoimmune disease).\n* Pregnancy or lactation.\n* Use of systemic antibiotics and\u002For anti-inflammatory drugs within the last 3 months.\n* Periodontal therapy within the last 6 months.\n* Current tobacco use (smoking\u002Fsmokeless) or vaping.\n* Limited\u002Fexpress CA plans (e.g., ≤ 11 aligners or expected completion \\\u003C 14 weeks).\n\nAnticipated early completion of CA or major treatment changes (e.g., switch to fixed appliances) within the next \\~4 months.\n\n\\- Extensive caries, defective restorations, or prostheses affecting index teeth\u002Fsites.",true,{"count":83,"type":20},21,[23],"This randomized crossover study will assess how three aligner-cleaning methods affect early supragingival oral microbial ecology and periodontal health in adults using clear aligners. Each participant will complete three (1-month) periods in a randomized sequence with (1-week) washouts between periods:\n\n1. Mechanical toothbrushing with fluoride toothpaste (control),\n2. Chlorhexidine (CHX) mouthwash, and\n3. an oxygen-based cleanser (BlueM).\n\nPrimary ecological outcomes focus on early dysbiosis indicators Fusobacterium nucleatum and Prevotella intermedia measured on retrieved aligner inner-surface biofilm and on supragingival plaque at the gingival margin. Secondary outcomes include periodontal indices (plaque index, gingival index, bleeding on probing) at index teeth and the host inflammatory marker MMP-8 in matrix-paired extracts (plaque and aligner).\n\nStudy visits occur at baseline and at the end of each 1-month period. Supragingival plaque is collected from the upper and lower first molars and central incisors; used aligners are swabbed immediately after removal. Participants are instructed to wear aligners about 22 hours\u002Fday, change trays every 10 days, remove aligners for meals and oral hygiene, and drink only water while aligners are in.\n\nLaboratory procedures include blinded culture enumeration under coded labels (performed by a single trained operator, FA), confocal laser scanning microscopy, and RNA isolation with species-specific qRT-PCR; microscopy is conducted unblinded after decoding. The study will determine whether chlorhexidine or an oxygen-based cleanser produces more favorable early ecological changes and periodontal outcomes than mechanical brushing alone in clear aligner therapy.",[87,88],"Gingivitis","Dental Plaque",[90,91,92,93,94,95,96,97,98,99,100,101,102,103],"Clear aligners","Chlorhexidine","BlueM","Oxygen-based cleanser","Mechanical toothbrushing","Supragingival plaque","Aligner biofilm","Fusobacterium nucleatum","Prevotella intermedia","MMP-8","Plaque index","Gingival index","Bleeding on probing","Randomized crossover","2026-01-06",{"date":106,"type":38},"2026-01-08",{"date":108,"type":20},"2026-02",{"date":110,"type":20},"2026-10",{"name":44,"class":45},{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":21,"phases":123,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":4},"100584926","clinical-evaluation-of-bioflx-crowns-and-preformed-zirconia-crowns-on-primary-second-molars-100584926","NCT06895707","Clinical Evaluation of BioFlx Crowns and Preformed Zirconia Crowns on Primary Second Molars","Clinical Evaluation of BioFlx Crowns and Preformed Zirconia Crowns on Primary Second Molars: a Randomized Clinical Trial","Inclusion Criteria:\n\n* Children aged 5-9 years old.\n* American Society of Anesthesiologists Classification I or II status.\n* Cooperative child.\n* Obtained informed consent.\n* Two primary lower second molars requiring full coverage restorations.\n* Primary lower second molars in functional occlusion with the opposing tooth and have at least one contact area with an adjacent tooth.\n* Primary lower second molars that can be adequately isolated.\n* Pulptomized primary lower second molars.\n* Primary lower second molars with multi-surface caries.\n\nExclusion Criteria:\n\n* American Society of Anesthesiologists Classification higher or equal to three statuses.\n* Informed consent is not obtained.\n* Allergy to local anesthesia.\n* Non-restorable primary lower second molars.","5 Years","9 Years",{"count":122,"type":20},50,[23],"The goal of this clinical trial is to clinically evaluate the performance of BioFlx in comparison to preformed zirconia crowns in the restoration of primary second molars in pediatric patients.\n\nThe main questions it aims to answer are:\n\nIs there a difference between BioFlx crowns (Group A) and one zirconia (Group B) in terms of crown retention (primary outcome)? Is there a difference between BioFlx crowns (Group A) and one zirconia (Group B) in modified gingival index, plaque index, occlusion, surface roughness, stain resistance, wear of opposing tooth, color match, anatomic form, marginal integrity and discoloration, proximal contact, and recurrent caries at the crown margins?\n\nResearchers will compare the clinical performance of Bioflx crowns and zirconia crowns to determine if they are similar.\n\nParticipants:\n\n* Participants will be asked to attend two appointments. During the first visit, a BioFlx crown will be placed on the primary lower second molar, and during the second visit, a zirconia crown will be placed on the contralateral primary lower second molar.\n* Participants will be recalled and evaluated after 3, 6, and 12 months.",[126],"Clincal Evaluation of BioFlx Vs. Zirconia Crowns","2025-03-25",{"date":129,"type":38},"2025-03-30",{"date":131,"type":20},"2025-05",{"date":133,"type":20},"2027-11",{"name":44,"class":45},{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":142,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":145,"phases":4,"briefSummary":146,"conditions":147,"keywords":150,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":46},"100569826","orthodontic-clear-aligners-vs-conventional-fixed-appliances-impact-on-muscular-activities-among-adults-using-semg-surface-electromyography-100569826","NCT06699290","Orthodontic Clear Aligners Vs Conventional Fixed Appliance's Impact on Muscular Activities Among Adults Using SEMG (Surface Electromyography)","An Orthodontic Clear Aligners Vs Conventional Fixed Appliances Impact on Muscular Activities Among Adults: a Surface Electromyography (sEMG) Prospective Comparative Study","Inclusion Criteria:\n\n* Adult Participants aged 16 years old and above.\n* Healthy growing Participants without any systemic diseases (assessed by taking a brief medical history ).\n* Participants with skeletal Class I relationship.\n* Participants with any other dental malocclusion referring to the Index of Orthodontic Treatment Need Index of orthodontic treatment needed (IOTN) .\n* No active extensive caries and with healthy periodontal tissues.\n\nExclusion Criteria:\n\n* Participants with any craniofacial anomalies, mental disabilities and\u002For neuropathic conditions.\n* Participants with history of neuromuscular disease and\u002F or truma.\n* Participants with the Presence of skeletal and\u002For diagnosed muscular asymmetries.\n* Participants with History of any previous orthodontic treatment.\n* Participants who have any signs of bruxism.\n* Participants with history of use of muscle relaxants.\n* Participants with true crossbites and\u002For with signs of Temporomandibular disorders (TMD) or condylar problems.\n* Participants with skeletal CL II and\u002For CL III relationships.\n* Participants with Hypodontia and\u002For with multiple missing posterior teeth (4 teeth and more).\n* Participants with maxillary constriction and posterior cross-bite (unilateral or bilateral) with an indication for orthognathic surgery.\n* Participants indicated for extraction orthodontic treatment.","16 Years",{"count":144,"type":20},60,"OBSERVATIONAL","This clinical trial goal is to evaluate the difference in masticatory activities in adult patients treated with clear aligners compared to conventional fixed appliances treatment.\n\nThe aim of this study is to measure the changes of the activity of the anterior temporalis and masseter muscles in different treatment modality.\n\nThe activity of the muscles will be evaluated and measured using the surface electromyography (sEMG) BioRadio device before and after the beginning of each treatment modality.",[148,149],"Masseter Muscle Activity","Anterior Temporalis Muscle Activity",[151,33,152,153,154],"Muscular activity","Conventional fixed therapy","Anterior temporalis","Masseter muscle","2024-11-22",{"date":157,"type":38},"2024-11-25",{"date":159,"type":20},"2025-03",{"date":161,"type":20},"2025-12",{"name":44,"class":45},{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":81,"sex":16,"minAge":170,"maxAge":171,"enrollmentInfo":172,"targetDuration":4,"studyType":21,"phases":174,"briefSummary":176,"conditions":177,"keywords":180,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":46},"100554741","phase-4-evaluate-cytotoxicity-leaching-and-structural-conformation-of-clear-aligners-100554741","NCT06503029","Evaluate Cytotoxicity, Leaching, and Structural Conformation of Clear Aligners","Cytotoxicity, Leaching, and Structural Conformation of Invisalign Clear Aligners Subjected to Different Cleaning Methods: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Participants who are on Invisalign Clear aligner treatment.\n* Participants who are 21 years and older and committed to their treatment.\n* Participants with caries-free dentition\n* Participants with no smoking habits\n* Participants are not pregnant females\n\nExclusion Criteria:\n\n* Participants who are on Orthognathic treatment.\n* Participants with Hypodontia.","21 Years","40 Years",{"count":173,"type":20},84,[175],"PHASE4","The aim is to evaluate clear aligners' cytotoxicity, leaching, and structural properties and compare them with four cleaning tools. The null hypothesis is the cleansers have no impact on the properties tested.",[178,179],"Malocclusion","Cytotoxicity",[179,181,182,183],"Leaching","Clear aligner","Orthodontics","2024-07-09",{"date":186,"type":38},"2024-07-16",{"date":188,"type":20},"2024-07-15",{"date":190,"type":20},"2025-03-05",{"name":44,"class":45},""]