Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2026-01-14 @ 3:49 AM
Study NCT ID:
NCT06772506
Status:
COMPLETED
Last Update Posted:
2025-01-14
First Post:
2025-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minimally Invasive Non-surgical Therapy for the Treatment of Splinted Stage IV Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C057473', 'term': 'Listerine'}, {'id': 'D000431', 'term': 'Ethanol'}, {'id': 'C033069', 'term': 'methyl salicylate'}, {'id': 'D008610', 'term': 'Menthol'}, {'id': 'D013943', 'term': 'Thymol'}, {'id': 'D013165', 'term': 'Splints'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000081005', 'term': 'Cyclohexane Monoterpenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D039821', 'term': 'Monoterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D016267', 'term': 'External Fixators'}, {'id': 'D009984', 'term': 'Orthopedic Fixation Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D053831', 'term': 'Surgical Fixation Devices'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'investigator'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-11', 'studyFirstSubmitDate': '2025-01-03', 'studyFirstSubmitQcDate': '2025-01-10', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CAL by millimeters', 'timeFrame': 'baseline, 3months and 6 months', 'description': 'Clinical attachment loss'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['periodontitis', 'stage IV', 'MINST', 'splint'], 'conditions': ['Periodontitis', 'Stage IV Periodontitis', 'Minimally Invasive Treatment', 'Splints']}, 'descriptionModule': {'briefSummary': 'Conventional periodontal treatment typically involves a combination of non-surgical and surgical approaches, such as scaling and root planing, followed by flap surgery and guided tissue regeneration. While these methods have demonstrated some success in managing periodontal disease, the low success rate in complex cases has prompted the exploration of alternative treatment modalities. One such approach is minimally invasive, non-surgical monotherapy, which aims to address the etiological source of the inflammation without the need for invasive surgical intervention.\n\nGuided tissue regeneration, a well-established technique in periodontal treatment, employs physical barrier membranes to exclude the proliferation of unwanted gingival fibroblasts and allow the regeneration of tooth-supporting structures such as the alveolar bone, periodontal ligament, and cementum.\n\nRecent advancements in dental therapies have led to the exploration of minimally invasive non-surgical approaches that aim to achieve comparable outcomes with reduced morbidity. This protocol outlines a randomized clinical trial to evaluate the efficacy and safety of a minimally invasive non-surgical monotherapy in treating patients with stage 4 periodontitis.\n\nIs minimally invasive non-surgical technique more effective in reducing tooth mobility and improving clinical parameters than conventional non-surgical technique?', 'detailedDescription': 'Periodontitis is a chronic inflammatory disease that affects the supporting structures of the teeth, including the gingiva, periodontal ligament, cementum, and alveolar bone. The advanced stages of periodontitis, such as stage 4, are characterized by severe tissue destruction, deepened pocket depths, and alveolar bone loss, which can ultimately lead to tooth mobility, drifting, and loss. Effective therapeutic interventions are necessary to halt the progression of the disease and potentially regenerate the lost periodontal tissues.\n\nConventional periodontal treatment typically involves a combination of non-surgical and surgical approaches, such as scaling and root planing, followed by flap surgery and guided tissue regeneration. While these methods have demonstrated some success in managing periodontal disease, the low success rate in complex cases has prompted the exploration of alternative treatment modalities. One such approach is minimally invasive, non-surgical monotherapy, which aims to address the etiological source of the inflammation without the need for invasive surgical intervention.\n\nGuided tissue regeneration, a well-established technique in periodontal treatment, employs physical barrier membranes to exclude the proliferation of unwanted gingival fibroblasts and allow the regeneration of tooth-supporting structures such as the alveolar bone, periodontal ligament, and cementum.\n\nRecent advancements in dental therapies have led to the exploration of minimally invasive non-surgical approaches that aim to achieve comparable outcomes with reduced morbidity. This protocol outlines a randomized clinical trial to evaluate the efficacy and safety of a minimally invasive non-surgical monotherapy in treating patients with stage 4 periodontitis.\n\nIs minimally invasive non-surgical technique more effective in reducing tooth mobility and improving clinical parameters than conventional non-surgical technique?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': '18-55 year old', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* periodontitis stage III and IV\n* Mobility grade 2\n* age from 18-55 years\n* medically free\n* nonsmoker\n* Single-rooted teeth\n\nExclusion Criteria:\n\n* Medically compromised patient\n* smokers\n* Bad oral hygiene\n* Non-surgical or surgical periodontal treatment in the past 12months.\n* Prolonged treatment with antibiotics or anti-inflammatory agents within 6months before periodontal therapy.'}, 'identificationModule': {'nctId': 'NCT06772506', 'briefTitle': 'Minimally Invasive Non-surgical Therapy for the Treatment of Splinted Stage IV Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Clinical and Patient-centered Outcomes After Minimally Invasive Non-surgical Therapy for the Treatment of Splinted Stage IV Periodontitis - Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'MINST in Periodontitis'}, 'secondaryIdInfos': [{'id': '2019-002239-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'conventional periodontal treatment with ultrasonic device and manual instruments', 'description': 'conventional non-surgical techniques with ultrasonic and manual scaler instruments', 'interventionNames': ['Procedure: Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo minimally invasive non surgical technique with mini five and after five instruments', 'description': 'and minimally invasive non-surgical technique using mini five and after five instruments+ ultrasonic device for supragingival instrumentation', 'interventionNames': ['Procedure: Minimally invasive non-surgical technique with mini five and after five minimally invasive instrument plus splint']}], 'interventions': [{'name': 'Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%)', 'type': 'PROCEDURE', 'description': 'non-surgical technique plus splint and ultrasonic device with 200 mg Tetracycline', 'armGroupLabels': ['conventional periodontal treatment with ultrasonic device and manual instruments']}, {'name': 'Minimally invasive non-surgical technique with mini five and after five minimally invasive instrument plus splint', 'type': 'PROCEDURE', 'otherNames': ['with ultrasonic device', 'mini five and after five instruments'], 'description': 'minimally invasive instruments, with mini five and after five minimally invasive instrument ultrasonic scaler device, conventional radiographic device and periodontal instruments with post-operative 1 gram penicillin for 3 days regulatory Statement: This study does not include an FDA-regulated device intervention, as the tools utilized are not the subject of investigation but are instead employed as part of routine clinical', 'armGroupLabels': ['Placebo minimally invasive non surgical technique with mini five and after five instruments']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12345', 'city': 'Cairo', 'state': 'Beni Suweif Governorate', 'country': 'Egypt', 'facility': 'Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'after publishing, i will share it'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer in department of periodontology', 'investigatorFullName': 'shaimaa hamdy', 'investigatorAffiliation': 'Nahda University'}}}}