[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654726":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":34,"studyPopulation":38,"armGroups":39,"interventions":50,"overallOfficials":60,"centralContacts":65,"locations":75,"responsibleParty":92,"collaborators":34,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":34,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":34,"enrollmentInfo":104,"targetDuration":34,"studyType":107,"phases":34,"briefSummary":108,"conditions":109,"keywords":113,"overallStatus":78,"whyStopped":34,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Altinbas University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":34},[9,13,16,19,22],{"measure":10,"description":11,"timeFrame":12},"Change in Full Mouth Plaque Score (FMPS) Between Fixed Orthodontic Appliance and Clear Aligner Groups","Full Mouth Plaque Score (FMPS) will be calculated as the percentage of tooth surfaces exhibiting visible plaque. The scale ranges from 0% to 100%, with higher scores indicating greater plaque accumulation and poorer plaque control.","Baseline (T0), after non-surgical periodontal treatment \u002F before orthodontic treatment initiation (T1), and 3 months after orthodontic treatment initiation (T2).",{"measure":14,"description":15,"timeFrame":12},"Change in Bleeding on Probing (BoP) Between Fixed Orthodontic Appliance and Clear Aligner Groups","Bleeding on probing (BoP) will be assessed at six sites per tooth using a periodontal probe. Bleeding occurring within 30 seconds after probing will be recorded as positive. The BoP score will be calculated as the percentage of bleeding-positive sites relative to the total number of sites examined, ranging from 0% to 100%, with higher scores indicating greater gingival inflammation.",{"measure":17,"description":18,"timeFrame":12},"Change in Gingival Index (GI) Between Fixed Orthodontic Appliance and Clear Aligner Groups","Gingival Index (GI) will be assessed according to the Löe and Silness criteria at six sites per tooth. The scale ranges from 0 to 3, where 0 indicates normal gingiva and 3 indicates severe gingival inflammation with a tendency for spontaneous bleeding. Higher scores indicate worse gingival inflammation.",{"measure":20,"description":21,"timeFrame":12},"Change in Probing Pocket Depth (PPD) Between Fixed Orthodontic Appliance and Clear Aligner Groups","Probing Pocket Depth (PPD) will be measured at six sites per tooth using a UNC-15 periodontal probe. PPD will be recorded in millimeters as the distance from the gingival margin to the base of the periodontal sulcus or pocket. Higher values indicate greater probing depth.",{"measure":23,"description":24,"timeFrame":12},"Change in Clinical Attachment Level (CAL) Between Fixed Orthodontic Appliance and Clear Aligner Groups","Clinical Attachment Level (CAL) will be measured at six sites per tooth using a periodontal probe and recorded in millimeters as the distance from the cementoenamel junction to the base of the periodontal sulcus or pocket. Higher values indicate greater attachment loss.",[26,30],{"measure":27,"description":28,"timeFrame":29},"Change in Oral Health Impact Profile-14 (OHIP-14) Score Between Fixed Orthodontic Appliance and Clear Aligner Groups","Oral health-related quality of life will be assessed using the Oral Health Impact Profile-14 (OHIP-14). The questionnaire includes 14 items scored on a 5-point Likert scale from 0 (never) to 4 (very often), producing a total score ranging from 0 to 56. Higher scores indicate poorer oral health-related quality of life.","Baseline (T0) and 3 months after orthodontic treatment initiation (T2).",{"measure":31,"description":32,"timeFrame":33},"Visual Analog Scale (VAS) Scores for Gingival Symptoms and Oral Hygiene Difficulty Between Fixed Orthodontic Appliance and Clear Aligner Groups","Patient-reported gingival symptoms and oral hygiene difficulty will be assessed using an 8-item Visual Analog Scale (VAS). Each item will be scored from 0 to 10. Higher scores will indicate greater symptom severity or greater oral hygiene difficulty for the symptom and difficulty items, whereas higher scores on the gingival health satisfaction item will indicate greater satisfaction.","At 3 months after orthodontic treatment initiation (T2).",null,{"allocation":34,"interventionModel":34,"interventionModelDescription":34,"primaryPurpose":34,"observationalModel":36,"timePerspective":37,"maskingInfo":34},"COHORT","PROSPECTIVE","Systemically healthy adults aged 18 years and older who are periodontally healthy or have gingivitis and have an indication for orthodontic treatment without tooth extraction will be recruited from patients presenting to the Altınbaş University Dental Hospital.",[40,45],{"label":41,"type":34,"description":42,"interventionNames":43},"CA Group (Clear Aligner Therapy)","Participants who will receive clear aligner therapy for correction of malocclusion. Prior to appliance placement, all participants will undergo standardized non-surgical periodontal treatment and receive oral hygiene instructions. Periodontal parameters and patient-reported outcomes will be assessed at baseline, after periodontal treatment, and at the third month of orthodontic therapy.",[44],"Device: Clear Aligner Therapy",{"label":46,"type":34,"description":47,"interventionNames":48},"FOA Group (Fixed Orthodontic Appliances)","Participants who will receive fixed orthodontic appliances (brackets and archwires) for correction of malocclusion. Prior to appliance placement, all participants will undergo standardized non-surgical periodontal treatment and receive oral hygiene instructions. Periodontal parameters and patient-reported outcomes will be assessed at baseline, after periodontal treatment, and at the third month of orthodontic therapy.",[49],"Device: Fixed Orthodontic Appliance",[51,56],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":34},"DEVICE","Fixed Orthodontic Appliance","Bracket-and-archwire system used for orthodontic tooth movement.",[46],{"type":52,"name":57,"description":58,"armGroupLabels":59,"otherNames":34},"Clear Aligner Therapy","Removable thermoplastic aligners used for orthodontic tooth movement.",[41],[61],{"name":62,"affiliation":63,"role":64},"Ravan Mammadov","Altınbaş University","PRINCIPAL_INVESTIGATOR",[66,71],{"name":67,"role":68,"phone":69,"phoneExt":34,"email":70},"Ravan Mammadov, DDS","CONTACT","+994507310770","revan.mamedov@gmail.com",{"name":72,"role":68,"phone":73,"phoneExt":34,"email":74},"Gulhuseyn Abdullayev, PhD, DDS","+994506770005","g.abdullayev20@gmail.com",[76],{"facility":77,"status":78,"city":79,"state":80,"zip":81,"country":82,"countryCode":34,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Altınbaş University Dental Hospital","RECRUITING","Istanbul","Bakirköy","34147","Turkey (Türkiye)",{"type":84,"coordinates":85},"Point",[86,87],28.94966,41.01384,{"lat":87,"lon":86},[90],{"name":67,"role":68,"phone":91,"phoneExt":34,"email":70},"05452120343",{"type":93,"investigatorFullName":62,"investigatorTitle":94,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"SPONSOR_INVESTIGATOR","PhD Candidate, Department of Periodontology, Altınbaş University","100654726","periodontal-health-in-adults-treated-with-fixed-orthodontic-appliances-or-clear-aligners-100654726",false,"NCT07802249","Periodontal Health in Adults Treated With Fixed Orthodontic Appliances or Clear Aligners","Comparative Effects of Fixed Orthodontic Appliances and Clear Aligners on Periodontal Health in Adults: A Prospective Observational Study","Inclusion Criteria:\n\n* Individuals aged 18 years or older\n* Systemically healthy individuals\n* Periodontally healthy individuals or those diagnosed with gingivitis\n* Probing pocket depth of 3 mm or less, with no clinical attachment loss and no reduced periodontium\n* Indication for orthodontic treatment\n* Orthodontic treatment planned without tooth extraction\n* Less than 5 mm of dental crowding in both the maxillary and mandibular arches, as determined by Hayes-Nance arch-length discrepancy analysis\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding individuals\n* Individuals with systemic disease that could influence periodontal status\n* Current use of cigarettes or other tobacco products\n* Individuals with a history of initial periodontal therapy within the preceding six months\n* Individuals who had previously undergone orthodontic treatment","ALL","18 Years",{"count":105,"type":106},30,"ESTIMATED","OBSERVATIONAL","This prospective observational study will compare the effects of fixed orthodontic appliances and clear aligners on periodontal health during the initial three months of orthodontic treatment. Thirty systemically healthy adults will be included in two groups of fifteen according to the orthodontic treatment modality received. Prior to appliance placement, all participants will undergo standardized non-surgical periodontal treatment and receive oral hygiene instructions. Periodontal parameters, including plaque accumulation, gingival inflammation, bleeding on probing, probing pocket depth, and clinical attachment level, will be assessed at baseline, following periodontal treatment, and at the third month of orthodontic therapy. Patient-reported outcomes related to oral health-related quality of life, gingival symptoms, and oral hygiene difficulty will also be evaluated. The study aims to determine whether periodontal and patient-reported outcomes differ between fixed orthodontic appliances and clear aligners during the early phase of orthodontic treatment.",[110,111,112],"Malocclusion","Periodontal Diseases","Periodontal Health",[114],"Periodontal Health, Clear Aligners, Fixed Orthodontic Appliances, Dental Biofilm, Oral Health Impact Profile-14, Visual Analog Scale","2026-09-10",{"date":117,"type":118},"2026-09-15","ACTUAL",{"date":120,"type":106},"2026-09-11",{"date":122,"type":106},"2027-01-30",{"name":62,"class":6},1]