[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615543":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":38,"studyPopulation":30,"armGroups":39,"interventions":55,"overallOfficials":64,"centralContacts":69,"locations":75,"responsibleParty":91,"collaborators":30,"id":94,"slug":30,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":30,"eligibilityCriteria":99,"healthyVolunteers":100,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":30,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":30,"overallStatus":78,"whyStopped":30,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"University of Baghdad","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Pain During Orthodontic Debonding Measured by VAS","Pain during debonding will be measured immediately after the procedure using VAS 0-100 mm, where 0 = no pain and 100 = worst imaginable pain.","During and immediately after debonding procedure",[14,18,22,26],{"measure":15,"description":16,"timeFrame":17},"Baseline Anxiety","Baseline anxiety will be assessed prior to the debonding procedure using the Modified Dental Anxiety Scale (MDAS).\n\nThe MDAS consists of five items, each scored on a 5-point Likert scale as follows:\n\nNot anxious = 1; Slightly anxious = 2; Fairly anxious = 3; Very anxious = 4; Extremely anxious = 5.\n\nThe total MDAS score is calculated as the sum of all five items, with a possible range from 5 to 25.\n\nA cut-off score of 19 or above indicates a highly dentally anxious patient, possibly dentally phobic.\n\nHigher scores indicate greater dental anxiety (worse outcome).","Prior to the debonding procedure",{"measure":19,"description":20,"timeFrame":21},"Patient Satisfaction","Satisfaction will be assessed immediately post-procedure using Numeric Rating Scale (0-10) to evaluate comfort and overall acceptance of the method.","immediately post-procedure",{"measure":23,"description":24,"timeFrame":25},"Device Application Time","Device application time will be recorded for each intervention and defined as the duration (in seconds) required to apply the pain reduction method prior to and\u002For during orthodontic debonding.","Periprocedural (during the debonding session)",{"measure":27,"description":28,"timeFrame":29},"Cost-Effectiveness Analysis","Direct costs, including device cost, consumables, and operator time, will be recorded for each intervention.\n\nCost-effectiveness ratios will be calculated as cost per unit reduction in pain score (VAS) to compare the efficiency of each pain-reduction method.","Periprocedural (during the debonding session) and at immediate post-procedure assessment.",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":34,"primaryPurpose":35,"observationalModel":30,"timePerspective":30,"maskingInfo":36},"RANDOMIZED","PARALLEL","Participants will be randomly assigned to one of three groups: TENS, high-frequency vibration, or control. Each participant will undergo a single session in which the assigned intervention is applied. The study is open-label, and all bracket removal procedures are performed by the same operator using standardized techniques to ensure consistency across groups. Baseline dental anxiety and sex will be recorded as covariates for analysis.","SUPPORTIVE_CARE",{"masking":37,"maskingDescription":30,"whoMasked":30},"NONE","This clinical study aims to evaluate and compare the effectiveness and cost-effectiveness of TENS (Dental Pain Eraser) and high-frequency vibration (SureSmile® VPro™) in reducing discomfort during orthodontic bracket removal, improving patient satisfaction, and optimizing efficiency. The study includes a control group, and results are intended to provide evidence-based guidance for orthodontists to enhance the patient experience during debonding procedures.\n\nParticipants will be individuals who have completed fixed orthodontic treatment and are scheduled for bracket removal. Before the procedure, their baseline dental anxiety will be assessed. The assigned intervention will be applied either immediately before (TENS) or during (vibration) the bracket removal session. Participants' experiences of pain and satisfaction will be monitored throughout the procedure. Sex and baseline anxiety will be considered in the analysis to evaluate their influence on outcomes. A cost-effectiveness analysis will be performed to determine the most efficient method among the interventions.\n\nThe research will be conducted in a standardized clinical setting, adhering to established bracket removal protocols to ensure participant safety and minimize variability. The procedures will be performed by the same operator following consistent techniques.\n\nThis study is designed to generate practical insights into pain management during orthodontic debonding, focusing on participant comfort, satisfaction, and procedural efficiency, without compromising the quality of care. The findings may guide future clinical recommendations and improve patient-centered orthodontic practice.",[40,46,51],{"label":41,"type":42,"description":43,"interventionNames":44},"Transcutaneous Electrical Nerve Stimulation (TENS)","EXPERIMENTAL","Participants in this arm will receive transcutaneous electrical nerve stimulation (TENS) applied immediately before orthodontic bracket removal. Pain, satisfaction, and procedural efficiency will be assessed during a single session.",[45],"Device: Transcutaneous Electrical Nerve Stimulation (TENS)",{"label":47,"type":42,"description":48,"interventionNames":49},"High-Frequency Vibration (SureSmile® VPro™)","Participants in this arm will receive high-frequency vibration applied during orthodontic bracket removal. Pain, satisfaction, and procedural efficiency will be assessed during a single session.",[50],"Device: High-Frequency Vibration",{"label":52,"type":53,"description":54,"interventionNames":30},"No Intervention","NO_INTERVENTION","Participants in this arm will undergo standard orthodontic bracket removal without any additional device. Pain, satisfaction, and procedural efficiency will be assessed during a single session.",[56,60],{"type":57,"name":41,"description":58,"armGroupLabels":59,"otherNames":30},"DEVICE","TENS is applied immediately before orthodontic bracket removal in a single session to reduce pain and improve patient satisfaction.",[41],{"type":57,"name":61,"description":62,"armGroupLabels":63,"otherNames":30},"High-Frequency Vibration","High-frequency vibration is applied during orthodontic bracket removal in a single session to reduce pain and improve patient satisfaction.",[47],[65],{"name":66,"affiliation":67,"role":68},"Ali M. Al-Attar, BDS, MSc, PhD","University of Baghdad - College of Dentistry - Orthodontics","PRINCIPAL_INVESTIGATOR",[70],{"name":71,"role":72,"phone":73,"phoneExt":30,"email":74},"Malak R. Alsaqqaf, B.D.S.","CONTACT","009647873431704","malak7alsaqqaf@gmail.com",[76],{"facility":77,"status":78,"city":79,"state":30,"zip":30,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"College of Dentistry, University of Baghdad","RECRUITING","Baghdad","Iraq","IQ",{"type":83,"coordinates":84},"Point",[85,86],44.40088,33.34058,{"lat":86,"lon":85},[89],{"name":90,"role":72,"phone":73,"phoneExt":30,"email":74},"Malak Alsaqqaf",{"type":68,"investigatorFullName":92,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Malak Ramzi Abdulmoula Alsaqqaf","Student Researcher","100615543",false,"NCT07293975","Pain Control During Braces Removal Using Transcutaneous Electrical Nerve Stimulation and High-Frequency Vibration","Assessment of Transcutaneous Electrical Nerve Stimulation and High-Frequency Vibration for Pain Control During Bracket Debonding: A Clinical Trial Study","Inclusion Criteria:\n\n1. Patients scheduled for fixed orthodontic appliance removal.\n2. Permanent dentition present, including both anterior and posterior teeth.\n3. Age between 15-35 years.\n4. Ability to provide informed consent and comply with study procedures.\n5. General health adequate for routine orthodontic care.\n6. No history of regular or recent medication intake within the preceding 24 hours, including painkillers, corticosteroids, or anti-flu drugs.\n\nExclusion Criteria:\n\n1. Patients with craniofacial anomalies, systemic conditions affecting pain perception, or taking medications influencing nociception.\n2. Teeth with extensive restorations or prostheses that prevent standard bracket debonding.\n3. Patients with known allergy or contraindication to TENS or vibration devices.\n4. Pregnant women.\n5. Active periodontal disease, including gingival recession or tooth mobility exceeding Grade I.\n6. Excessive gingival overgrowth that may impede debonding or influence study outcomes.",true,"ALL","15 Years","35 Years",{"count":105,"type":106},90,"ESTIMATED","INTERVENTIONAL",[109],"NA","This study aims to find the best method to reduce pain during braces removal. We are comparing transcutaneous electrical nerve stimulation (TENS), high-frequency vibration, and a control group with no additional intervention.\n\nPeople who have completed orthodontic treatment and need their braces removed can take part. Participants will be randomly assigned to one of the three groups. The vibration device will be applied during the braces removal, while TENS will be applied just before the procedure.\n\nBefore the procedure, participants' anxiety will be measured using the Modified Dental Anxiety Scale (MDAS). During and after the procedure, pain will be assessed using a Visual Analog Scale (VAS) from 0 to 100, and participants will rate their satisfaction using a Numerical Rating Scale (NRS) from 0 to 10.\n\nThe purpose of this research is to help orthodontists identify the method that makes braces removal less uncomfortable, more tolerable, and more satisfying for patients.",[112],"Orthodontic Pain","2026-04-17",{"date":115,"type":116},"2026-04-20","ACTUAL",{"date":118,"type":116},"2026-01-01",{"date":120,"type":106},"2026-09",{"name":5,"class":6},1]