[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"deep-margin-elevation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:deep-margin-elevation":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,73,98],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"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":20,"type":21},81,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28],"Deep Margin Elevation","Pulpal and Periodontal Health",[30,31,32],"Deep margin elevation","Pulpal and Periodontal health","Class II Composite restorations","RECRUITING","2025-09-05",{"date":36,"type":37},"2025-09-11","ACTUAL",{"date":39,"type":37},"2025-05-01",{"date":41,"type":21},"2027-05-01",{"name":43,"class":44},"Postgraduate Institute of Dental Sciences Rohtak","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":16,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":4},"100585323","the-effect-of-bulk-filling-flowable-composite-on-caries-recurrence-in-deep-marginal-elevation-a-randomized-clinical-trial-100585323","NCT06900868","The Effect of Bulk Filling Flowable Composite on Caries Recurrence in Deep Marginal Elevation: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Adults patients (20-50)\n* Good oral hygiene (plaque index 0 or 1 )\n* Patient approving to participate in the study\n* Absence of parafunctional habits and\u002For bruxism\n* No sign of irreversible pulpitis\n* No periapical radiolucency\n* Deep subgingival margin\n* Molars class II with subgingival margin\n\nExclusion Criteria:\n\n* • Patients with known allergic or adverse reaction to the tested materials.\n\n  * Systematic disease that may affect participation.\n  * Xerostomic patients.\n  * Bad oral hygiene (plaque index 2 or 3 )\n  * Heavy smokers\n  * Patients undergoing or will start orthodontic treatment\n  * Patients with removable prothesis","20 Years","50 Years",{"count":55,"type":21},50,[24],"Deep marginal elevation usinge a bioactive dental material in deep subgingival Class II restorations, S-PRG filler-containing materials offer significant benefits due to their bioactive properties, Their ability to release fluoride, remineralization potential and acid neutralization, reducing the risk of recurrent caries, particularly at the gingival margin(Imazato et al. 2023). The antibacterial and antifungal effects help inhibit biofilm formation, enhancing the longevity of restorations. Additionally, these materials support better marginal adaptation by reducing microleakage and improving bond durability (Imazato et al. 2023) This type of composite may improve the outcomes of deep subgingival margin elevation, benefiting both restorative success and periodontal health(Imazato et al. 2023).",[59,60,61,27],"DME","Dental Caries","Dental",[30],"NOT_YET_RECRUITING","2025-03-22",{"date":66,"type":37},"2025-03-28",{"date":68,"type":21},"2025-03-20",{"date":70,"type":21},"2026-04-20",{"name":72,"class":44},"Future University in Egypt",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":86,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":4},"100585211","rct-deep-margin-elevation-by-self-adhesive-composite-100585211","NCT06899412","Rct Deep Margin Elevation by Self Adhesive Composite","Clinical Evaluation of Success Rate of Deep Marginal Elevation Technique Using Self-adhesive Flowable Composite Versus Conventional Bonded Flowable Composite: Randomized Clinical Trial","Inclusion Criteria:\n\nPatients accept the one year follow up period. Cooperative patients. The study recruited volunteers of both genders Age from 21 to 45 years Primary compound proximal caries, with International Caries Detection and Assessment System (ICDAS) scores of 4 or 5.\n\nThe buccolingual width of the lesion could not exceed two-thirds of the intercuspal distance.\n\nThe remaining dentin thickness not less than 1 mm from the pulp and that could be identified clinically and by periapical xray Vital teeth without any signs of radiolucency in the periapical or furcation areas.\n\nParticipants also had to present a moderate risk of caries.\n\nExclusion Criteria:\n\nThose who requiring any form of pulp capping will excluded to differentiate postoperative hypersensitivity from pulpal inflammation.\n\nIndividuals with poor oral hygiene. Patients undergoing orthodontic treatment. Periodontal surgery patients. Smokers. Pregnant women. Patients without occlusal contact. Those suffering prolonged tooth pain that disrupted sleep.","21 Years","45 Years",{"count":55,"type":21},[24],"This study intend to study the development and introduction of new efficient approaches to overcome the problems of technique sensitivity of deep margin elevation by conventional flowable composite. This new class of Self- adhesive composites that have been developed and were marketed as flowable, low viscosity resin composites does not require any etching or bonding strategy before cavity filling and the ability to wet and adapt easily.The procedure is simplified by eliminating the adhesive application, which is the most technique sensitive step. (Fu J, Kakuda S, Pan F, e t al. 2013).\n\nDME addresses multiple clinical problems associated with sub-gingival margins which pose a challenge due to limited access, rubber dam slippage over the margin and subsequent persistent saliva,\n\ncrevice fluid and blood leakage. There are uncertainties within the profession in providing DME, and it is still considered a new approach. A recent survey revealed 78% of dentists had more than one concern about the procedure, ranging from isolation and inspection, marginal adaptation, microleakage. (Taylor, Burns, 2024) FIT SA™, a new comprehensive self-adhesive flowable restorative with bioactive Giomer Technology inside. FIT SA has eliminated the need for the technique sensitive bonding procedure. FIT SA offers superior strength and polishability, and the unique filler structure combines the light transmission and diffusion properties of enamel and dentin to blend well withthe surrounding dentition.",[27],[87,88,89],"deep margin","composite restorations","class II","2025-03-21",{"date":66,"type":37},{"date":93,"type":21},"2025-08-01",{"date":95,"type":21},"2026-09-01",{"name":97,"class":44},"Cairo University",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":16,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":108,"conditions":109,"keywords":110,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":4},"100583378","clinical-performance-of-high-viscosity-bioactive-injectable-composite-in-deep-marginal-elevation-100583378","NCT06875544","Clinical Performance of High Viscosity Bioactive Injectable Composite in Deep Marginal Elevation","Clinical Performance of High Viscosity Bioactive Injectable Composite in Deep Marginal Elevation Randomized Controlled Trail","Randomized","Inclusion Criteria:\n\n1. Adult Patient (20-50 years old)\n2. Good oral hygiene (plaque index 0 or 1)\n3. Patient approval\n4. Absence of parafunctional habits and\u002For bruxism\n5. No endodontic treatment\n6. No abscess\n7. No partial or fixed denture\n\nExclusion Criteria:\n\n1. Patients with known allergic or adverse reaction to the tested materials.\n2. Bad oral hygiene\n3. Systematic disease that may affect participation.\n4. Xerostomic patients.\n5. Patients with active periodontal disease.\n6. Heavy smokers (those who smoke greater than or equal to 25 or more cigarettes a day)\n7. Orthodontic treatment patient",{"count":55,"type":21},[24],"Using a bioactive resin composite in subgingival Class II cavities can provide enhanced caries resistance by releasing multiple ions, including fluoride. This approach offers greater resistance to caries due to the incorporation of surface pre-reacted glass filler (S-PRG) technology (Imazato, Nakatsuka et al., 2023).\n\nThis type of composite may improve the outcomes of deep subgingival margin elevation, benefiting both restorative success and periodontal health.",[59,61,27],[111],"deep margin elevation","2025-03-08",{"date":114,"type":37},"2025-03-13",{"date":116,"type":21},"2025-03",{"date":118,"type":21},"2026-04",{"name":72,"class":44}]