[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659624":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":36,"overallOfficials":48,"centralContacts":53,"locations":58,"responsibleParty":79,"collaborators":13,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":13,"eligibilityCriteria":87,"healthyVolunteers":84,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":13,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":61,"whyStopped":13,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Rehman Medical Institute - RMI","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Intraoperative Pain Perception During Caries Excavation assessed using Visual Analogue Scale (VAS)","Intraoperative pain perception will be determined on visual analogue scale (VAS) to measure the pain intensity experienced by the patients during caries excavation. VAS involves scores from 0 to 10 where 0 indicates no pain and 10 represents worst pain possible. The VAS score will be recorded immediately after completion of caries excavation.","immediately after completion of caries excavation",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","Dental caries is a biofilm-mediated disease in which the progression of the carious lesion results in the demineralization and structural breakdown of dental hard tissues. Contemporary operative dentistry emphasizes minimally invasive management, with the selective removal of irreversibly damaged, infected dentin while preserving tissue that may remain structurally and biologically capable of repair. The choice of caries excavation technique may influence the amount of sound tooth structure removed, the mechanical stimulation of dentin, treatment time, and patient comfort.\n\nConventional rotary excavation is commonly performed using diamond or carbide burs. Although effective, rotary instrumentation may involve unnecessary removal of sound or potentially remineralizable dentin and can produce mechanical and thermal stimuli that may contribute to discomfort during treatment. Alternative excavation methods have therefore been developed to achieve more selective removal of carious tissue.\n\nSmart polymer burs are designed to selectively remove softer, infected dentin while minimizing cutting of harder, sound dentin. The burs are manufactured from a polymer material with a hardness intermediate between infected and sound dentin. They are used at low rotational speed and are intended to reduce unnecessary removal of tooth structure. When the bur encounters harder dentin, its cutting efficiency is reduced, thereby supporting a more conservative excavation approach.\n\nCarisolv is a chemomechanical caries-removal system. Its gel formulation contains sodium hypochlorite together with amino acids and is intended to soften altered carious dentin. Following chemical softening, the softened tissue is removed with appropriate hand instrumentation. The technique is based on selective removal of carious tissue rather than conventional high-speed mechanical cutting.\n\nThe present study is designed as a three-arm, parallel-group randomized clinical trial. After assessment and enrollment, participants will be allocated to one of three intervention groups using a simple randomization procedure. The intervention will be performed on the eligible carious tooth according to the assigned excavation technique. The same clinical operator or appropriately trained operator will follow a standardized protocol for the respective technique to minimize variation in treatment delivery.\n\nFor the Smart-bur group, carious dentin will be excavated using the designated polymer bur with a slow-speed handpiece according to the manufacturer's recommended operating conditions. For the Carisolv group, the Carisolv gel will be applied to the carious dentin according to the manufacturer's instructions, allowed to act on the affected tissue, and the softened carious material will subsequently be removed using suitable hand instruments. For the conventional group, caries will be excavated using conventional diamond burs with rotary instrumentation according to routine operative dentistry principles.\n\nRadiographic and clinical assessment will be used before treatment to confirm the suitability of the selected tooth and to reduce the likelihood of including teeth with pulpal involvement. Treatment will be carried out under standardized clinical conditions. Participants will be monitored throughout the procedure, and the assigned excavation technique will be discontinued or modified if clinically indicated for patient safety or appropriate dental treatment.\n\nBaseline demographic and relevant clinical information will be documented on a standardized data-collection form. Treatment allocation and study-related observations will be recorded by the research team under appropriate supervision. Data will subsequently be entered into a statistical database for analysis.\n\nThe principal analytical comparison will assess whether the three excavation techniques differ in the level of pain reported during the caries-removal procedure. Continuous variables will initially be summarized using appropriate descriptive statistics. Distributional assumptions will be assessed before selection of the final comparative statistical test. For normally distributed data, one-way analysis of variance will be used to compare the three independent groups. If the assumptions for parametric analysis are not satisfied, an appropriate non-parametric alternative will be considered. Statistical significance will be assessed at an alpha level of 0.05.\n\nThe study is intended to provide clinical evidence regarding the effect of different caries excavation approaches on patient comfort and to contribute to the evidence base for minimally invasive operative dentistry. The findings may help clinicians understand whether selective polymer-bur or chemomechanical excavation techniques provide a clinically meaningful difference in patient-reported discomfort compared with conventional rotary excavation.",[22,27,31],{"label":23,"type":24,"description":13,"interventionNames":25},"Smart\u002FPolymer Burs","EXPERIMENTAL",[26],"Device: polymer burs",{"label":28,"type":24,"description":13,"interventionNames":29},"Carisolv",[30],"Device: Carisolv",{"label":32,"type":33,"description":13,"interventionNames":34},"Conventional Diamond Burs","ACTIVE_COMPARATOR",[35],"Device: Conventional Diamond Burs",[37,42,45],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":13},"DEVICE","polymer burs","Carious dentin will be selectively excavated using Smart polymer burs operated at low speed (500-800 rpm), aiming to preserve sound dentin.",[23],{"type":38,"name":28,"description":43,"armGroupLabels":44,"otherNames":13},"Carious dentin will be chemically softened using Carisolv gel and subsequently removed with hand instruments.",[28],{"type":38,"name":32,"description":46,"armGroupLabels":47,"otherNames":13},"Carious dentin will be removed using conventional rotary diamond burs under standard clinical operative dentistry procedures.",[32],[49],{"name":50,"affiliation":51,"role":52},"Tehreema Naureen, Bachelor of Dental Surgery","Rehman College of Dentistry, Peshawar","PRINCIPAL_INVESTIGATOR",[54],{"name":50,"role":55,"phone":56,"phoneExt":13,"email":57},"CONTACT","+923325566872","tnaureen41@gmail.com",[59],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Rehman College of Dentistry","RECRUITING","Peshawar","Khyber Pakhtunkhwa","25000","Pakistan","PK",{"type":68,"coordinates":69},"Point",[70,71],71.57849,34.008,{"lat":71,"lon":70},[74,78],{"name":75,"role":55,"phone":76,"phoneExt":13,"email":77},"Meera Tanveer, Public Health","+923349534604","meera.tanveer@rmi.edu.pk",{"name":50,"role":52,"phone":13,"phoneExt":13,"email":13},{"type":52,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"Tehreema Naureen","Post Graduate Trainee","100659624","comparison-of-intraoperative-pain-perception-during-caries-excavation-using-smart-burs-and-carisolv-to-conventional-diamond-burs-100659624",false,"NCT07869407","Comparison of Intraoperative Pain Perception During Caries Excavation Using Smart Burs and Carisolv to Conventional Diamond Burs","Inclusion Criteria:\n\n* Be male or female.\n* Be 18-45 years of age.\n* Have at least one active carious lesion with exposed dentin in an asymptomatic mandibular molar.\n* Have an ICDAS II Code 5 lesion: a dentinal cavity clearly visible clinically, with the cavity surface feeling soft or leathery on gentle probing.\n* Have a radiograph showing a clear band of dentin between the carious lesion and the pulp.\n* Provide written informed consent to participate.\n\nExclusion Criteria:\n\n* Symptoms\u002Fsigns of pulpitis.\n* Pulp exposure.\n* Abscess formation, including swelling, redness, or a fistula adjacent to the affected tooth.\n* Necrotic pulp, indicated by lack of response to cold testing.\n* Cardiovascular disease.\n* Diabetes mellitus.\n* Hypertension.\n* Severe periodontal disease.\n* Pregnancy.\n* Unwillingness or inability to provide informed consent\u002Fparticipate.","ALL","18 Years","45 Years",{"count":92,"type":93},66,"ESTIMATED","INTERVENTIONAL",[96],"NA","The goal of this randomized controlled trial is to compare the amount of pain experienced during removal of dental caries using Smart burs, Carisolv, and conventional diamond burs in adults aged 18-45 years with active caries in asymptomatic mandibular molars.\n\nThe main questions it aims to answer are:\n\nDoes the method used for caries removal affect the amount of pain experienced?\n\nIs there a difference in pain perception between Smart burs, Carisolv, and conventional diamond burs?\n\nResearchers will compare the three treatment groups to see whether pain perception during caries excavation differs between the methods.\n\nParticipants will:\n\nBe randomly assigned to one of three groups: Smart burs, Carisolv, or conventional diamond burs.\n\nUndergo caries removal using the assigned method.\n\nRate their pain during the procedure using a 0-10 Visual Analogue Scale (VAS).",[99],"Pain During Caries Excavation",[101,102,103,104,105,28,106,107,108,109,110],"Dental Caries","Caries excavation","Intraoperative pain","Pain perception","Smart polymer burs","Diamond burs","Minimally invasive dentistry","Chemomechanical caries removal","Operative dentistry","Caries removal techniques","2026-10-07",{"date":113,"type":114},"2026-10-09","ACTUAL",{"date":116,"type":114},"2026-07-01",{"date":118,"type":93},"2027-01-30",{"name":5,"class":6},1]