[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656755":3},{"organization":4,"outcomesModule":7,"designInfo":49,"detailedDescription":59,"studyPopulation":48,"armGroups":60,"interventions":73,"overallOfficials":82,"centralContacts":86,"locations":91,"responsibleParty":106,"collaborators":108,"id":112,"slug":113,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":48,"eligibilityCriteria":118,"healthyVolunteers":119,"sex":120,"minAge":121,"maxAge":48,"enrollmentInfo":122,"targetDuration":48,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":140,"whyStopped":48,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"Ho Chi Minh City Odonto-Stomatology Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":48},[9],{"measure":10,"description":11,"timeFrame":12},"Pain Intensity During Cavity Preparation","Participant-reported pain intensity will be assessed immediately after each cavity preparation procedure using the Wong-Baker pain scale, ranging from 0 to 10, with higher scores indicating greater pain. Pain scores after Er:YAG laser cavity preparation and conventional rotary cavity preparation will be compared within participants.","Immediately after each cavity preparation procedure at each of the two treatment visits",[14,18,22,26,30,33,36,39,42,45],{"measure":15,"description":16,"timeFrame":17},"Treatment Procedure Time","The duration of the treatment procedure using each cavity preparation method will be recorded in seconds using a stopwatch. Procedure times for Er:YAG laser and conventional rotary instrumentation will be compared within participants.","Periprocedural, from the start to the completion of cavity preparation at each of the two treatment visits.",{"measure":19,"description":20,"timeFrame":21},"Heart Rate During Cavity Preparation","Heart rate will be measured using a finger pulse monitoring device before and during each cavity preparation procedure and recorded in beats per minute. Heart rate measurements associated with Er:YAG laser and conventional rotary cavity preparation will be compared.","Immediately before and during each cavity preparation procedure",{"measure":23,"description":24,"timeFrame":25},"Participant Treatment Preference","After experiencing both cavity preparation methods, participants will indicate whether they prefer Er:YAG laser cavity preparation or conventional rotary cavity preparation for future dental treatment.","Immediately after the second treatment visit, approximately 1 week after the first treatment visit.",{"measure":27,"description":28,"timeFrame":29},"Presence of Cavity Surface Burning on SEM","Presence or absence of surface burning will be assessed on extracted study teeth using scanning electron microscopy (SEM) and compared between Er:YAG laser-prepared and conventional rotary-prepared cavities.","Approximately 1 month after cavity preparation, following orthodontically indicated tooth extraction",{"measure":31,"description":32,"timeFrame":29},"Presence of Cavity Surface Carbonization on SEM","Presence or absence of carbonization will be assessed using scanning electron microscopy on extracted study teeth and compared between the two cavity preparation methods.",{"measure":34,"description":35,"timeFrame":29},"Presence of Cavity Margin Cracks on SEM","Presence or absence of cracks at the cavity margins will be assessed using scanning electron microscopy and compared between Er:YAG laser and conventional rotary cavity preparation.",{"measure":37,"description":38,"timeFrame":29},"Hybrid Layer Thickness","Hybrid layer thickness will be measured in micrometers using scanning electron microscopy on extracted study teeth and compared between the two cavity preparation methods.",{"measure":40,"description":41,"timeFrame":29},"Adhesive Layer Thickness","Adhesive layer thickness will be measured in micrometers using scanning electron microscopy on extracted study teeth and compared between the two cavity preparation methods.",{"measure":43,"description":44,"timeFrame":29},"Partially Demineralized Dentin Zone Thickness","The thickness of the partially demineralized dentin zone will be measured in micrometers using scanning electron microscopy and compared between Er:YAG laser and conventional rotary cavity preparation.",{"measure":46,"description":47,"timeFrame":29},"Microleakage Dye Penetration","Microleakage will be quantified as dye penetration depth in micrometers. Extracted teeth will be examined under polarized light microscopy at 40× magnification, and dye penetration will be measured using NIS-Elements software.",null,{"allocation":50,"interventionModel":51,"interventionModelDescription":52,"primaryPurpose":53,"observationalModel":48,"timePerspective":48,"maskingInfo":54},"NON_RANDOMIZED","PARALLEL","Split-mouth within-participant design. Each participant will receive both cavity preparation methods on two different permanent premolars at separate visits. One premolar will undergo cavity preparation with an Er:YAG laser, and the other premolar will undergo preparation with conventional rotary instruments. Each participant will serve as their own control.","TREATMENT",{"masking":55,"maskingDescription":56,"whoMasked":57},"SINGLE","Participants and the treating clinician will not be masked because of the obvious procedural differences between Er:YAG laser and conventional rotary instrumentation. For the ex vivo microleakage assessment, two examiners blinded to the cavity preparation method will independently evaluate dye penetration.",[58],"OUTCOMES_ASSESSOR","This is an interventional, split-mouth study designed to evaluate the safety and effectiveness of Er:YAG laser cavity preparation compared with conventional rotary instrumentation.\n\nAdult participants undergoing orthodontic treatment who have permanent premolars scheduled for extraction will be enrolled. Two eligible permanent premolars from each participant will be included. A Class I cavity will be prepared using an Er:YAG laser in one tooth and conventional rotary instruments in the other tooth. Both procedures will be performed by the same dentist at separate visits on different days.\n\nClinical assessments will include the time required for cavity preparation, pain experienced immediately after each procedure, changes in pulse rate during treatment, and the participant's preferred treatment method after experiencing both techniques.\n\nFollowing cavity preparation, the teeth will be restored with composite resin. Approximately one month later, the study teeth will be extracted according to the participant's pre-existing orthodontic treatment plan. The extracted teeth will then undergo ex vivo laboratory evaluation.\n\nSelected specimens will be examined using scanning electron microscopy to assess cavity and tooth-restoration interface characteristics. Laboratory evaluation will also assess microleakage between the two cavity preparation methods.\n\nThe study will compare the clinical acceptability and ex vivo characteristics of Er:YAG laser cavity preparation with those of conventional rotary cavity preparation.",[61,67],{"label":62,"type":63,"description":64,"interventionNames":65},"Er:YAG Laser Cavity Preparation","EXPERIMENTAL","One eligible permanent premolar from each participant will undergo Class I cavity preparation using an Er:YAG laser. Each participant will also receive conventional rotary cavity preparation on another eligible permanent premolar as part of the split-mouth design.",[66],"Procedure: Er:YAG Laser",{"label":68,"type":69,"description":70,"interventionNames":71},"Conventional Rotary Cavity Preparation","ACTIVE_COMPARATOR","Another eligible permanent premolar from each participant will undergo Class I cavity preparation using conventional rotary instrumentation. Each participant will also receive Er:YAG laser cavity preparation on another eligible permanent premolar as part of the split-mouth design.",[72],"Procedure: Conventional Rotary Cavity Preparation",[74,79],{"type":75,"name":76,"description":77,"armGroupLabels":78,"otherNames":48},"PROCEDURE","Er:YAG Laser","Class I cavity preparation will be performed using an Er:YAG laser with a non-contact handpiece in QSP mode for hard-tissue cavity preparation. Residual carious tissue will be checked with a caries detector and additional preparation performed if needed. The cavity will then be restored with composite resin according to the study protocol.",[62],{"type":75,"name":68,"description":80,"armGroupLabels":81,"otherNames":48},"Class I cavity preparation will be performed using conventional rotary instrumentation with a water-cooled diamond bur. Residual carious tissue will be checked with a caries detector and additional preparation performed if needed. The cavity will then be restored with composite resin according to the study protocol.",[68],[83],{"name":84,"affiliation":5,"role":85},"Van TT Nguyen, MSc","PRINCIPAL_INVESTIGATOR",[87],{"name":84,"role":88,"phone":89,"phoneExt":48,"email":90},"CONTACT","+84 918883700","ntthaovan@gmail.com",[92],{"facility":5,"status":48,"city":93,"state":93,"zip":94,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":102,"contacts":103},"Ho Chi Minh City","71011","Vietnam","VN",{"type":98,"coordinates":99},"Point",[100,101],106.62965,10.82302,{"lat":101,"lon":100},[104,105],{"name":84,"role":88,"phone":89,"phoneExt":48,"email":90},{"name":84,"role":85,"phone":48,"phoneExt":48,"email":48},{"type":107,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR",[109],{"name":110,"class":111},"University of Medicine and Pharmacy at Ho Chi Minh City","OTHER","100656755","eryag-laser-for-dental-cavity-preparation-100656755",false,"NCT07831720","Er:YAG Laser for Dental Cavity Preparation","Safety and Effectiveness of Er:YAG Laser in Cavity Preparation","Inclusion Criteria:\n\n* Adult participants with permanent maxillary or mandibular premolars scheduled for extraction for orthodontic reasons.\n* Eligible premolars are intact or have carious lesions limited to the enamel and are free of pain symptoms.\n* Where carious lesions are present, teeth meet the study eligibility criteria based on ICDAS II 2009, as specified in the study protocol.\n* Participants voluntarily agree to participate and provide informed consent.\n* No spontaneous or continuous dental pain.\n* Clinical examination, thermal pulp testing, and electric pulp testing are consistent with normal pulp status.\n* Radiographic examination shows no periapical radiolucency and complete root apex formation.\n* Participants have no systemic health condition that could adversely affect healing.\n\nExclusion Criteria:\n\n* Participants with psychological or behavioral conditions that prevent adequate cooperation with the study procedures.\n* Teeth showing radiographic evidence of internal root resorption or pulp canal calcification.",true,"ALL","18 Years",{"count":123,"type":124},20,"ESTIMATED","INTERVENTIONAL",[127],"NA","The goal of this clinical trial is to compare Er:YAG laser cavity preparation with conventional rotary instruments in adults who have permanent premolars planned for extraction as part of orthodontic treatment.\n\nThe main questions the study aims to answer are:\n\nHow do Er:YAG laser and conventional rotary instruments compare in the time needed for cavity preparation? Do participants experience different levels of pain with the two methods? Which cavity preparation method do participants prefer after experiencing both methods? Are there differences in cavity surface and interface characteristics and microleakage between teeth prepared with the two methods?\n\nResearchers will compare Er:YAG laser cavity preparation with conventional rotary cavity preparation using a split-mouth design. Each participant will receive both treatment methods on two different eligible permanent premolars.\n\nParticipants will:\n\nHave one eligible premolar prepared with an Er:YAG laser and another eligible premolar prepared with conventional rotary instruments.\n\nHave the two procedures performed at separate visits on different days. Rate their pain after each procedure and indicate which treatment method they would prefer for future dental treatment.\n\nHave the study teeth extracted approximately 1 month later, as already planned for their orthodontic treatment.\n\nAfter extraction, the teeth will be examined in the laboratory to compare cavity surface and interface characteristics and microleakage between the two preparation methods.",[130],"Dental Caries",[132,133,134,135,136,137,138,139],"Er:YAG laser","Dental cavity preparation","Split-mouth study","Class I cavity","Microleakage","Scanning electron microscopy","Patient preference","Restorative dentistry","NOT_YET_RECRUITING","2026-09-15",{"date":143,"type":144},"2026-09-21","ACTUAL",{"date":146,"type":124},"2026-09",{"date":148,"type":124},"2027-07",{"name":5,"class":6},1]