[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605958":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":30,"centralContacts":35,"locations":45,"responsibleParty":65,"collaborators":29,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":29,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":29,"enrollmentInfo":77,"targetDuration":29,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":48,"whyStopped":29,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Postgraduate Institute of Dental Sciences Rohtak","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Class II cavities 2mm to \u003C3mm above the alveolar crest","EXPERIMENTAL","DME is performed in Class II cavities 2mm to \\\u003C3mm above the alveolar crest and restored with composite.",[13],"Procedure: Deep Margin Elevation",{"label":15,"type":10,"description":16,"interventionNames":17},"Class II cavities 1mm to \u003C2mm above the alveolar crest","DME is performed in Class II cavities 1mm to \\\u003C2mm above the alveolar crest and restored with composite.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Class II cavities ≥3mm above the alveolar crest","ACTIVE_COMPARATOR","DME is performed in Class II cavities ≥3mm above the alveolar crest and restored with composite.",[13],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"PROCEDURE","Deep Margin Elevation","The tooth preparation is performed using conventional diamond burs. The extent of caries decides the group into which the participant falls. A precontoured sectional matrix (Palodent) with a properly sized plastic diamond wedge (Bioclear Matrix Systems) is applied and stabilized using a separating ring to ensure closure of deep cervical margins, adaptation of the matrix cervically and attain contact tightness. A 37% phosphoric acid etch gel is used for Selective Enamel Etching technique for 15-20 seconds. Two coats of adhesive are applied to both enamel and dentin using a microbrush and light cured. Flowable bulkfill composite (SDR plus, Dentsply, Sirona) restorative composite is placed using teflon coated hand instruments to perform DME till the level of CEJ and light cured for 20s. Further build up of proximal box is done using packable composite. The restoration is finished using fine grit yellow coded tapered diamond stones. Polishing done by using Composite Polishing kits.",[15,9,19],null,[31],{"name":32,"affiliation":33,"role":34},"Dr. Mayank Arora, MDS","PGIDS, Rohtak","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":29,"email":40},"Dr. Mayank Arora","CONTACT","8295964200","drarora002@gmail.com",{"name":42,"role":38,"phone":43,"phoneExt":29,"email":44},"Dr. Swathi C","8618677427","swathic188@gmail.com",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"PGIDS","RECRUITING","Rohtak","Haryana","124001","India","IN",{"type":55,"coordinates":56},"Point",[57,58],76.58917,28.89447,{"lat":58,"lon":57},[61,63],{"name":32,"role":38,"phone":39,"phoneExt":29,"email":62},"dr.arora002@gmail.com",{"name":64,"role":38,"phone":43,"phoneExt":29,"email":44},"Dr. Swathi C, Post Graduate student",{"type":66,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100605958","impact-of-dme-on-pulpal-and-periodontal-health-at-varying-gingival-seat-level-100605958",false,"NCT07169305","Impact of DME on Pulpal and Periodontal Health at Varying Gingival Seat Level","Impact of DME on Pulpal and Periodontal Health at Varying Gingival Seat Level in Class II Subgingival Composite Restorations","Inclusion Criteria:\n\n* Patients at least 18 years of age at the time of treatment.\n\n  * Permanent Posterior teeth exhibiting proximal caries lesion extending subgingivally below the cemento-enamel junction (CEJ). The axial extent of the caries should not be more than 75% of the dentin thickness.\n  * Sound tooth structure of atleast 1mm should be present from the alveolar crest to the base of the cavity\u002F gingival seat after cavity preparation.\n  * The tooth should either be asymptomatic or have reversible pulpitis as determined by history and pulp sensibility testing. There should be no history of spontaneous or lingering pain\n  * Periodontally sound tooth\n  * Full mouth plaque score (FMPS): ≤ 15% and Full mouth bleeding score (FMBS): ≤15%\n\nExclusion Criteria:\n\n* Presence of bone disease (metabolic, endocrine, infectious, tumoral, developmental pathologies)\n\n  * Pregnant or lactating and history of smoking or alcohol abuse\n  * Anti inflammatory drug consumption within past 3 days\n  * Uncontrolled or poorly controlled diabetes\n  * Unstable Life threatening conditions or requiring antibiotic prophylaxis.\n  * Presence of detectable plaque and Bleeding on probing on the tooth to be treated\n  * Thin gingival biotype, Periodontitis and Gingival recession\n  * Class II cavities with gingival margin above the CEJ\n  * Previously restored teeth\n  * Absence of adjacent tooth or antagonist or Crown in adjacent tooth.\n  * H\u002Fo Bruxism, Xerostomia\n  * Requiring gingivectomy\n  * Isolation with rubber dam not possible",true,"ALL","18 Years",{"count":78,"type":79},81,"ESTIMATED","INTERVENTIONAL",[82],"NA","The classical idea was to keep the biologic width untouched in order to maintain periodontal health but the newer case reports have given a new dimension to this concept, stating that a limited extension into STA can be used as an alternative for invasive procedures like SCL. The periodontal tissues can still tolerate subgingival margin placement in biologic width when restorations are free of overhangs which are real culprit for providing room for plaque retention and further inflammation. There are no sufficient clinical studies with good sample size to prove the significance of this concept. Hence, we are performing a Non Randomized Controlled trial by placing gingival margins at various levels above the alveolar crest and restoring it with composite and further evaluate the periodontal tissue health, pulpal health, restoration quality and significance of DME.",[26,85],"Pulpal and Periodontal Health",[87,88,89],"Deep margin elevation","Pulpal and Periodontal health","Class II Composite restorations","2025-09-05",{"date":92,"type":93},"2025-09-11","ACTUAL",{"date":95,"type":93},"2025-05-01",{"date":97,"type":79},"2027-05-01",{"name":5,"class":6},1]