Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-31 @ 5:10 PM
Study NCT ID:
NCT06936605
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-20
First Post:
2025-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RGD With Minimally Invasive Non-Surgical Technique in Treatment of Periodontal Intrabony Defect
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'C047981', 'term': 'arginyl-glycyl-aspartic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'patients do not know the type of treatment and outcomes assessor does not know type of group'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Groups and intervention:\n\nPatients selected in this study will be classified into three groups:\n\n* Group 1: Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with modified minimally invasive surgical technique (MINST) and RGD hydrogel injection.\n* Group 2: Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with (MINST) and hydrogel injection.\n* Group : Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with (MINST) alone.\n\nPostoperative phase:\n\n1. Routine verbal and written postoperative instructions will be given to all patients.\n2. Patients will be advised to refrain from retracting the cheeks, to accomplish food mastication in areas away from surgical site, and to avoid brushing the area in the first week.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2025-04-10', 'studyFirstSubmitQcDate': '2025-04-17', 'lastUpdatePostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CAL by millimeters', 'timeFrame': 'baseline, 3months and 6 months', 'description': 'Measure clinical attachment loss pre and after-intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MINST', 'RGD', 'intrabony defect'], 'conditions': ['Intrabony Defect', 'Periodontal Diseases', 'Alveolar Bone Loss']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://doi.org/10.1590/1678-7757-2023-0263', 'label': 'RGD in treatment of intrabony defect'}]}, 'descriptionModule': {'briefSummary': 'Periodontal regeneration is a complex process that involves coordinated activities and interactions of many cell types, extracellular matrix, cytokines, and specific growth factors to restore tissue integrity. The most important challenge facing periodontal regeneration is cellular insufficiency. Periodontal defects usually have a limited regenerative capacity due to their bounded surface area which is supposed to provide the wound area with a limited number of viable cells and a limited amount of biologic mediators. Cell recruitment and adhesion into the defect area are essential for cells to survive and secrete collagen.\n\nApoptosis is initiated when failure in adhesion in many different cell types occurs. Some periodontal treatment options failed in the reconstruction of the defect due to failure in wound stabilization and subsequent cell adhesion. Many treatment options have been developed to enhance defect stability and cellular recruitment including the use of GTM and different biologics. However, the treatment outcomes vary considerably depending on the level of the defect cellularity and the degree of cell recruitment into the defect area. For maximum outcomes, enhanced stability, vascularity, and biologics-sustained delivery were suggested. The minimally invasive surgical technique (MIST) suggested by Cortellini et al. offers a suitable level of tissue preservation that could help in defect stability and cellular adhesion. It was suggested to promote flap stability, maintain space, and maintain a greater amount of blood supply at the alveolar crest and papillary levels.', 'detailedDescription': 'Periodontitis is an inflammatory multifactorial disease initiated by pathogenic bacteria accumulated as a biofilm on the tooth surface leading to clinical attachment loss (CAL), pocket formation (PD), bleeding on probing (BOP), and bone loss which if neglected may lead to increased tooth mobility and final tooth loss. Pathological tooth mobility may arise from extensive alveolar bone loss, traumatic occlusion, acute periodontal inflammation, and apical tooth displacement. Treating tooth mobility can be a challenging process, particularly for patients with severe periodontitis, including those in stage III or IV, who often experience a range of these symptoms. ue to compromised periodontal support. Therefore, effective treatment not only relies on periodontal therapy but also on occlusal stability and tooth splinting'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • All patients included will have moderate to advanced periodontitis.\n\n * Patients included in this study will be free from any systemic diseases according to criteria of Modified Cornell Medical Index(10).\n * Patients who had not undergone any type of regenerative periodontal therapy six months prior to the initial examination.\n\nExclusion Criteria:\n\n* • Patients with systemic diseases, smokers, pregnant (female).\n\n * Patients received antibiotics or non-steroidal anti-inflammatory drugs six months before the beginning of the study.'}, 'identificationModule': {'nctId': 'NCT06936605', 'acronym': 'MINST + RGD', 'briefTitle': 'RGD With Minimally Invasive Non-Surgical Technique in Treatment of Periodontal Intrabony Defect', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'The Use of Integrin Binding Domain Loaded Hydrogel (RGD) With Minimally Invasive Non-Surgical Technique in Treatment of Periodontal Intrabony Defect (Randomized Clinical Trial Study)', 'orgStudyIdInfo': {'id': 'MINST+ RGD in Periodontitis'}, 'secondaryIdInfos': [{'id': 'committee 1051', 'type': 'OTHER', 'domain': 'ethical committee faculty of dentistry minia university'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'negative control group', 'description': 'Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with minimally invasive non-surgical technique', 'interventionNames': ['Drug: RGD Peptide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with minimally invasive non-surgical technique with placebo hydrogel', 'interventionNames': ['Drug: RGD Peptide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'study group', 'description': 'Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with minimally invasive non-surgical technique with RGD hydrogel', 'interventionNames': ['Drug: RGD Peptide']}], 'interventions': [{'name': 'RGD Peptide', 'type': 'DRUG', 'description': 'RGD peptide is an integrin binding site', 'armGroupLabels': ['control group', 'negative control group', 'study group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'shaimaa Hamdy, lecturer of Periodontology', 'role': 'CONTACT', 'email': 'shimaa.3m.sh@gmail.com', 'phone': '+201030576405', 'phoneExt': '+201555035523'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'after complete study and publishing all data well be available'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer in periodontology', 'investigatorFullName': 'shaimaa hamdy', 'investigatorAffiliation': 'Minia University'}}}}