Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 1:47 AM
Study NCT ID:
NCT07310732
Status:
COMPLETED
Last Update Posted:
2025-12-30
First Post:
2025-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Radiographic Assessment of Efficacy of Modified Minimally Invasive SurgicalTechnique (M-MIST) Alone and Combined With Enamel Matrix Proteins and Ox-derived Bone Graft in the Treatment of Single Bone Defects Between Teeth.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D016301', 'term': 'Alveolar Bone Loss'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D001862', 'term': 'Bone Resorption'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C109069', 'term': 'enamel matrix proteins'}, {'id': 'D014183', 'term': 'Transplantation, Heterologous'}], 'ancestors': [{'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-20', 'studyFirstSubmitDate': '2025-09-26', 'studyFirstSubmitQcDate': '2025-12-20', 'lastUpdatePostDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Probing Pocket Depth', 'timeFrame': '24 weeks', 'description': 'The depth of probe penetration into the pocket (millimeters) is measured from the gingival margin using an UNC-15 probe.'}, {'measure': 'Clinical Attachment Level', 'timeFrame': '24 weeks', 'description': 'The distance from the base of the pocket to cemento-enamel junction (millimeters) is measured using an UNC-15 probe.'}], 'secondaryOutcomes': [{'measure': 'Full mouth plaque score', 'timeFrame': '24 weeks', 'description': 'Turesky Modification of Quigley-Hein Index used to assess plaque buildup across all tooth surfaces (buccal, lingual, mesial, distal) with scoring 0 (no plaque) to 5 (heavy plaque)'}, {'measure': 'Full mouth bleeding score', 'timeFrame': '24 weeks', 'description': 'Probe is inserted and withdrawn at the distal point of the tooth and monitored for bleeding within 10 seconds. Registered with (+) availability of provoked bleeding and with (-) its absence.'}, {'measure': 'Mean defect depth', 'timeFrame': '24 weeks', 'description': 'measured as the distance fromt the alveolar crest to the base of the defect (in CBCT)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontal Diseases', 'Periodontal Bone Loss']}, 'referencesModule': {'references': [{'pmid': '21303402', 'type': 'BACKGROUND', 'citation': 'Cortellini P, Tonetti MS. Clinical and radiographic outcomes of the modified minimally invasive surgical technique with and without regenerative materials: a randomized-controlled trial in intra-bony defects. J Clin Periodontol. 2011 Apr;38(4):365-73. doi: 10.1111/j.1600-051X.2011.01705.x. Epub 2011 Feb 8.'}, {'pmid': '8483088', 'type': 'BACKGROUND', 'citation': 'Cortellini P, Pini Prato G, Tonetti MS. Periodontal regeneration of human infrabony defects. II. Re-entry procedures and bone measures. J Periodontol. 1993 Apr;64(4):261-8. doi: 10.1902/jop.1993.64.4.261.'}, {'pmid': '8483087', 'type': 'BACKGROUND', 'citation': 'Cortellini P, Pini Prato G, Tonetti MS. Periodontal regeneration of human infrabony defects. I. Clinical measures. J Periodontol. 1993 Apr;64(4):254-60. doi: 10.1902/jop.1993.64.4.254.'}, {'pmid': '11829385', 'type': 'BACKGROUND', 'citation': 'Camelo M, Nevins ML, Lynch SE, Schenk RK, Simion M, Nevins M. Periodontal regeneration with an autogenous bone-Bio-Oss composite graft and a Bio-Gide membrane. Int J Periodontics Restorative Dent. 2001 Apr;21(2):109-19.'}]}, 'descriptionModule': {'briefSummary': 'This study was performed to investigate the adjunctive clinical benefit of the application of enamel matric derivatives and xenograft with the modified minimally invasive surgical technique in the treatment of isolated intrabony defects in periodontally compromised subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least one site associated with an intrabony defect of ≥3 mm involving predominantly the interdental space of the tooth\n* patients with optimal compliance\n\nExclusion Criteria:\n\n* Patients with uncontrolled or poorly controlled diabetes\n* history of long-term use of medications\n* allergic to medications\n* pregnant or lactating women\n* smokers/users of other tobacco products'}, 'identificationModule': {'nctId': 'NCT07310732', 'briefTitle': 'Clinical and Radiographic Assessment of Efficacy of Modified Minimally Invasive SurgicalTechnique (M-MIST) Alone and Combined With Enamel Matrix Proteins and Ox-derived Bone Graft in the Treatment of Single Bone Defects Between Teeth.', 'organization': {'class': 'OTHER', 'fullName': 'Rungta College of Dental Sciences and Research'}, 'officialTitle': 'Clinical and Tomographic Efficacy of the Modified Minimally Invasive Surgical Technique (M-MIST) Alone and Combined With Enamel Matrix Derivative (EMD) and Bone Mineral Derived Xenograft (BMDX), in the Treatment of Isolated, Inter-dental Intra-bony Defects', 'orgStudyIdInfo': {'id': 'RCDSR/IEC/MDS/2021/b-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'modified minimally invasive surgical technique', 'interventionNames': ['Procedure: modified minimally invasive surgical technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'modified minimally invasive surgical technique with emdogain', 'interventionNames': ['Procedure: modified minimally invasive surgical technique plus emdogain']}, {'type': 'EXPERIMENTAL', 'label': 'modified minimally invasive surgical technique with emdogain and xenograft', 'interventionNames': ['Procedure: modified minimally invasive surgical technique plus emdogain and xenograft']}], 'interventions': [{'name': 'modified minimally invasive surgical technique', 'type': 'PROCEDURE', 'description': 'modified minimally invasive surgical technique alone in interdental area', 'armGroupLabels': ['modified minimally invasive surgical technique']}, {'name': 'modified minimally invasive surgical technique plus emdogain', 'type': 'PROCEDURE', 'description': 'modified minimally invasive surgical technique with application of enamel matrix proteins in interdental area', 'armGroupLabels': ['modified minimally invasive surgical technique with emdogain']}, {'name': 'modified minimally invasive surgical technique plus emdogain and xenograft', 'type': 'PROCEDURE', 'description': 'modified minimally invasive surgical technique with application of enamel matrix proteins and placement of bovine bone graft in interdental area', 'armGroupLabels': ['modified minimally invasive surgical technique with emdogain and xenograft']}]}, 'contactsLocationsModule': {'locations': [{'zip': '490023', 'city': 'Bhilai', 'state': 'Chhattisgarh', 'country': 'India', 'facility': 'Department of Periodontics, Rungta College of Dental Sciences and Research', 'geoPoint': {'lat': 21.20919, 'lon': 81.4285}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rungta College of Dental Sciences and Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dean', 'investigatorFullName': 'Karthik Krishna M', 'investigatorAffiliation': 'Rungta College of Dental Sciences and Research'}}}}