[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623533":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":47,"collaborators":26,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":26,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":26,"enrollmentInfo":60,"targetDuration":26,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":76,"whyStopped":26,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Riyadh Elm University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Fixed orthodontic treatment control group","ACTIVE_COMPARATOR","Study subjects in control group will receive fixed orthodontic appliances with metallic brackets of 0.022-inch slot size (American Orthodontics). The bonding process will be performed using the same adhesive (BracePaste, American Orthodontics) for all patients, and treatment will be initiated with 0.014-inch NiTi archwires (Highland Metals).",[13],"Device: Fixed orthodontic appliances",{"label":15,"type":16,"description":17,"interventionNames":18},"Clear Aligner Treatment Group","EXPERIMENTAL","Study subjects in Clear Aligner treatment group will receive Invisalign® (Align Technology, Inc., Tempe, AZ, USA). The Clear Aligner treatment protocol will be followed until the end of the treatment.",[19],"Device: Clear Aligner Treatment",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Fixed orthodontic appliances","Study subjects in control group will receive fixed orthodontic appliances with metallic brackets of 0.022-inch slot size (American Orthodontics).",[9],null,{"type":22,"name":28,"description":17,"armGroupLabels":29,"otherNames":26},"Clear Aligner Treatment",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Razan Musaad Alsalamah","CONTACT","00966553771240","razan.alsalamah2024@student.riyadh.edu.sa",[37],{"facility":5,"status":26,"city":38,"state":26,"zip":26,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":26},"Riyadh","Saudi Arabia","SA",{"type":42,"coordinates":43},"Point",[44,45],46.72185,24.68773,{"lat":45,"lon":44},{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Omar Alkadhi","Associate Professor, Preventive Dentistry Department College of Medicine and Dentistry, Riyadh Elm University","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":61,"type":62},40,"ESTIMATED","INTERVENTIONAL",[65],"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.",[68,69],"Orthodontic Treatment","Saliva",[71,72,73,74,75],"Salivary flow","Salivary pH","Buffering capacity","Fixed orthodontic appliance","Clear aligner therapy","NOT_YET_RECRUITING","2026-02-02",{"date":79,"type":80},"2026-02-09","ACTUAL",{"date":82,"type":62},"2026-03-15",{"date":84,"type":62},"2027-05-29",{"name":5,"class":6},1]