[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616600":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":45,"centralContacts":52,"locations":63,"responsibleParty":83,"collaborators":57,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":57,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":94,"minAge":95,"maxAge":57,"enrollmentInfo":96,"targetDuration":57,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":119,"whyStopped":57,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Riyadh Elm University","OTHER",[8,16,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Sequence ABC: Brushing then CHX Mouthwash then BlueM","EXPERIMENTAL","Participant completes three 1-month periods in order (A to B to C), each separated by a 1-week washout. A = Mechanical toothbrushing with fluoride toothpaste (control); B = Chlorhexidine (CHX) mouthwash; C = Oxygen-based cleanser (BlueM). Trays are changed every 10 days; aligners are worn 22 h\u002Fday; water-only while aligners are in.",[13,14,15],"Behavioral: Mechanical toothbrushing (fluoride toothpaste)","Drug: Chlorhexidine mouthwash (0.2%)","Other: Oxygen-based cleanser",{"label":17,"type":10,"description":18,"interventionNames":19},"Sequence BCA: CHX Mouthwash then BlueM then Brushing","Participant completes three 1-month periods in order (B to C to A), each separated by a 1-week washout. A = Mechanical toothbrushing with fluoride toothpaste (control); B = CHX mouthwash; C = Oxygen-based cleanser (BlueM). Trays are changed every 10 days; aligners are worn 22 h\u002Fday; water-only while aligners are in.",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"Sequence CAB: BlueM then Brushing then CHX Mouthwash","Participant completes three 1-month periods in order (C to A to B), each separated by a 1-week washout. A = Mechanical toothbrushing with fluoride toothpaste (control); B = CHX mouthwash; C = Oxygen-based cleanser (BlueM). Trays are changed every 10 days; aligners are worn 22 h\u002Fday; water-only while aligners are in.",[13,14,15],[25,32,39],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"BEHAVIORAL","Mechanical toothbrushing (fluoride toothpaste)","Control oral-hygiene period using mechanical toothbrushing with a fluoride-containing toothpaste, per standardized study instructions, for the assigned 1-month period. No chlorhexidine or oxygen-based cleanser is used during this period; aligners are removed for oral-hygiene procedures per protocol.",[9,17,21],[31],"Colgate Total",{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DRUG","Chlorhexidine mouthwash (0.2%)","Chlorhexidine mouthwash used per standardized study instructions for the assigned 1-month period. No oxygen-based cleanser is used during this period; aligners are removed for mouthrinse use and oral-hygiene procedures per protocol. A 1-week washout without cleaning products separates periods.",[9,17,21],[38],"CHX",{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Oxygen-based cleanser","Oxygen-based cleanser (BlueM) used per standardized study instructions for the assigned 1-month period. No chlorhexidine is used during this period; aligners are removed for product use and oral-hygiene procedures per protocol. A 1-week washout without cleaning products separates periods.",[9,17,21],[44],"BlueM",[46,49],{"name":47,"affiliation":5,"role":48},"Dr. Faisal A Althobaiti, BDS","PRINCIPAL_INVESTIGATOR",{"name":50,"affiliation":5,"role":51},"Dr. Nancy M Ajwa, MSc","STUDY_DIRECTOR",[53,59],{"name":54,"role":55,"phone":56,"phoneExt":57,"email":58},"Faisal A Althobaiti, BDS","CONTACT","+966594496974",null,"faisal.althobaiti2024@student.riyadh.edu.sa",{"name":60,"role":55,"phone":61,"phoneExt":57,"email":62},"Nancy M Ajwa, MSc","+966554804564","nancy.ajwa@riyadh.edu.sa",[64],{"facility":65,"status":57,"city":66,"state":67,"zip":57,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Riyadh Elm University - Orthodontic Clinics","Riyadh","Riyadh Region","Saudi Arabia","SA",{"type":71,"coordinates":72},"Point",[73,74],46.72185,24.68773,{"lat":74,"lon":73},[77,80,81],{"name":78,"role":55,"phone":79,"phoneExt":57,"email":58},"Faisal A Althoabiti, BDS","+996594496974",{"name":60,"role":55,"phone":61,"phoneExt":57,"email":62},{"name":82,"role":48,"phone":57,"phoneExt":57,"email":57},"Faisal Althobaiti, BDS",{"type":48,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":57,"oldOrganization":57},"Faisal Ali Althobaiti","Principal Investigator","100616600","clear-aligner-cleaning-brushing-chlorhexidine-and-bluem-effects-on-oral-microbial-ecology-and-periodontal-indices-100616600",false,"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,"ALL","18 Years",{"count":97,"type":98},21,"ESTIMATED","INTERVENTIONAL",[101],"NA","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.",[104,105],"Gingivitis","Dental Plaque",[107,108,44,40,109,110,111,112,113,114,115,116,117,118],"Clear aligners","Chlorhexidine","Mechanical toothbrushing","Supragingival plaque","Aligner biofilm","Fusobacterium nucleatum","Prevotella intermedia","MMP-8","Plaque index","Gingival index","Bleeding on probing","Randomized crossover","NOT_YET_RECRUITING","2026-01-06",{"date":122,"type":123},"2026-01-08","ACTUAL",{"date":125,"type":98},"2026-02",{"date":127,"type":98},"2026-10",{"name":5,"class":6},1]