Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2025-12-30 @ 10:11 PM
Study NCT ID:
NCT07031895
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-20
First Post:
2025-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of Hyaluronic Acid in Bone Regeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006820', 'term': 'Hyaluronic Acid'}, {'id': 'D014183', 'term': 'Transplantation, Heterologous'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-15', 'studyFirstSubmitDate': '2025-06-02', 'studyFirstSubmitQcDate': '2025-06-19', 'lastUpdatePostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bone formation', 'timeFrame': 'until the end of the histological examination 4 months after the socket preservation procedure', 'description': 'At the 4-month follow-up, dental implants will be placed in the edentulous areas where grafts were applied. During the preparation of the implant sockets, bone samples will be collected and examined histologically.\n\nTissue samples obtained for histological examination will be fixed in a 10% formaldehyde solution for 72 hours. Following fixation, the tissues will undergo a decalcification process. After decalcification, a routine histological tissue processing protocol will be applied.\n\nThe obtained histological images will be evaluated according to the classification by Jerry Bouquot.\n\nTissues obtained from the study will also be analyzed using immunohistochemical staining under a light microscope (Olympus BX51, Tokyo, Japan). The sections will be examined under a light microscope (Olympus BX51, Tokyo, Japan). For all femoral sections obtained from subjects in the experimental groups, the intensity of AP and TRAP immunoreactivity will be calculated at 40× magnification using the ImageJ.'}], 'secondaryOutcomes': [{'measure': 'Radiographic bone evaluation', 'timeFrame': 'up to the radiographic evaluations at 4 and 10 months after the socket preservation procedure', 'description': 'Cone-beam computed tomography (CBCT) scans will be obtained from each patient at three different time points throughout the study:\n\nBefore socket preservation\n\nAt 4 months after socket preservation (prior to implantation)\n\nAt 6 months after implantation\n\nUsing these scans, bone density, vertical and horizontal gain parameters will be measured.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Socket Preservation', 'hyaluronic acid', 'bone formation'], 'conditions': ['Socket Preservation']}, 'referencesModule': {'references': [{'pmid': '39382763', 'type': 'BACKGROUND', 'citation': 'Kloss FR, Kau T, Heimes D, Kammerer PW, Kloss-Brandstatter A. Enhanced alveolar ridge preservation with hyaluronic acid-enriched allografts: a comparative study of granular allografts with and without hyaluronic acid addition. Int J Implant Dent. 2024 Oct 9;10(1):42. doi: 10.1186/s40729-024-00559-6.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/39382763/', 'label': 'Enhanced alveolar ridge preservation with hyaluronic acid-enriched allografts: a comparative study of granular allografts with and without hyaluronic acid addition'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/25749077/', 'label': 'Clinical and histologic outcomes of socket grafting after flapless tooth extraction: a systematic review of randomized controlled clinical trials'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/22784417/', 'label': 'Tissue changes of extraction sockets in humans: a comparison of spontaneous healing vs. ridge preservation with secondary soft tissue healing'}]}, 'descriptionModule': {'briefSummary': 'Bone loss due to resorption is commonly observed in the alveolar socket following tooth extraction. This situation makes it difficult to preserve sufficient bone volume that would allow for ideal implant placement in cases requiring dental implants. Alveolar ridge preservation is a procedure aimed at minimizing bone resorption and preserving the volume and morphology of the alveolar ridge after tooth extraction.\n\nThe aim of this study is to evaluate the clinical effectiveness of socket preservation using a xenograft enriched with hyaluronic acid in patients with defective extraction sockets.\n\nThis study is designed as a randomized, controlled clinical trial including three parallel groups:\n\nStudy group - Patients whose alveolar bone was evaluated using cone-beam computed tomography (CBCT) will undergo tooth extraction, followed by the application of a bovine-derived graft/xenograft enriched with hyaluronic acid into the socket. Patients will be evaluated clinically, radiologically, and histologically at the 4th month. Dental implants will be placed in the edentulous areas where the graft was applied. Bone samples will be taken during the preparation of the implant sockets, and the bone tissue will be examined histologically. A third CBCT scan will be taken 6 months after implant placement to assess new bone formation and implant success radiographically.\n\nComparison group - Patients whose alveolar bone was evaluated using CBCT will undergo tooth extraction, followed by the application of a standard bovine-derived graft/xenograft into the socket. Patients will be evaluated clinically, radiologically, and histologically at the 4th month. Dental implants will be placed in the edentulous areas where the graft was applied. Bone samples will be taken during the preparation of the implant sockets, and the bone tissue will be examined histologically. A third CBCT scan will be taken 6 months after implant placement to assess new bone formation and implant success radiographically.\n\nControl group - Patients whose alveolar bone was evaluated using CBCT will undergo tooth extraction, and the socket will be left to heal naturally without the application of any graft material. Patients will be evaluated clinically, radiologically, and histologically at the 4th month. Dental implants will be placed in the edentulous areas. Bone samples will be taken during the preparation of the implant sockets, and the bone tissue will be examined histologically. A third CBCT scan will be taken 6 months after implant placement to assess new bone formation and implant success radiographically.', 'detailedDescription': "Following tooth extraction, volume loss due to bone resorption is observed in the alveolar socket. This condition complicates the preservation of sufficient bone volume that would allow for ideal implant placement in cases requiring dental implants. Alveolar ridge preservation is a procedure aimed at minimizing bone resorption and maintaining the volume and morphology of the alveolar ridge after tooth extraction. In this procedure, the goal is to provide structural support and a scaffold for new bone formation by using materials such as autogenous grafts, allografts, xenografts, barrier membranes, platelet-rich fibrin, bone morphogenetic proteins, and other growth factors. This approach supports bone regeneration by promoting osteogenesis and osteoconduction. Although current methods maintain their effectiveness, variability in outcomes is still observed. This highlights the need for more extensive research into different graft materials and innovative approaches.\n\nHyaluronic acid has emerged as a promising biomaterial for alveolar ridge preservation due to its multifaceted biological effects on tissue regeneration and wound healing. Its viscoelastic properties help maintain hydration and structural integrity at the graft site, reducing graft shrinkage and supporting vertical stability. Additionally, by interacting with cell surface receptors, it stimulates osteoblast activity and inhibits osteoclastogenesis, thereby contributing to increased bone density and improved biointegration of the graft material. Clinical studies have also demonstrated that hyaluronic acid enhances angiogenesis, strengthening the osteoconductive properties of graft materials and optimizing clinical outcomes in alveolar ridge preservation.\n\nThe aim of this study is to evaluate the clinical efficacy of socket preservation using a xenograft enriched with hyaluronic acid in patients with defective extraction sockets. Over a 10-month period, the study group receiving a hyaluronic acid-enriched xenograft will be compared with a control group receiving a standard xenograft and another control group left to natural healing after tooth extraction. Evaluated outcomes include horizontal and vertical bone gain, graft stability, residual graft, bone marrow presence, and bone mineral density.\n\nThis study is designed as a randomized, controlled clinical trial including three parallel groups:\n\nStudy group - Patients whose alveolar bone is pre-evaluated using cone-beam computed tomography (CBCT) will receive a bovine-derived graft/xenograft enriched with hyaluronic acid in the extraction socket after tooth removal. Patients will be evaluated clinically, radiologically, and histologically at 4 months. Dental implants will be placed in the edentulous areas where the graft was applied. Bone samples will be collected during the preparation of the implant sockets and analyzed histologically. A third CBCT scan will be performed 6 months after implant placement to radiographically assess new bone formation and implant success.\n\nComparison group - Patients whose alveolar bone is pre-evaluated using CBCT will receive a standard bovine-derived graft/xenograft in the extraction socket after tooth removal. Patients will be evaluated clinically, radiologically, and histologically at 4 months. Dental implants will be placed in the grafted areas. Bone samples will be collected during implant socket preparation and analyzed histologically. A third CBCT scan will be performed 6 months after implant placement to assess new bone formation and implant success.\n\nControl group - Patients whose alveolar bone is pre-evaluated using CBCT will undergo tooth extraction without graft material application, allowing for natural healing of the socket. Patients will be evaluated clinically, radiologically, and histologically at 4 months. Dental implants will be placed in the edentulous areas. Bone samples will be collected during the preparation of the implant sockets and analyzed histologically. A third CBCT scan will be performed 6 months after implant placement to assess new bone formation and implant success.\n\nHistopathological Studies Tissue samples collected for histological analysis will be fixed in 10% formaldehyde solution for 72 hours. After fixation, samples will undergo decalcification using a solution composed of 10% formaldehyde, 80% distilled water, and 10% nitric acid. Following decalcification, standard histological tissue processing will be performed. Prepared sections will be stained with Hematoxylin and Eosin (H\\&E) for general histological structure and Masson's Trichrome (MT) specifically for connective tissue evaluation. Microscopic evaluation will be performed using an Olympus BX51 light microscope (Olympus Corp., Tokyo, Japan) according to defined criteria, and measurements will be analyzed statistically using the ImageJ software program.\n\nThe obtained histological images will be evaluated according to Jerry Bouquot's classification (UTHSC School of Dentistry, Houston):\n\nGrade 0 - No bone formation observed\n\nGrade 1 - Minimal bone formation observed\n\nGrade 2 - Moderate bone formation observed\n\nGrade 3 - Considerable bone formation observed\n\nGrade 4 - Extensive bone formation observed\n\nTissues collected from the study will also be analyzed using immunohistochemical staining to show the expression of Tartrate Resistant Acid Phosphatase (TRAP) and Alkaline Phosphatase (AP). For the different experimental groups, AP (Anti-Alkaline Phosphatase Antibody 100 μl, Abcam cat no: ab95462) will be used to demonstrate osteoblast activity, and TRAP (Rabbit Anti TRAP/Tartrate Resistant Acid Phosphatase Polyclonal Antibody, Bioss cat no: bs-6434R) will be used to determine osteoclast activity.\n\nImageJ software will be used at X40 magnification to calculate the intensity of AP and TRAP immunoreactivity in all femoral sections collected from the subjects in all experimental groups, and the results will be recorded."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Socket type: Sockets with less than 50% bone resorption in the buccal and palatal/lingual walls according to the Kim JJ classification (Type I-IVa)\n\nAge range: 18-65 years\n\nAbsence of active periodontal disease\n\nNo systemic diseases\n\nPatients who will attend regular follow-up visits\n\nExclusion Criteria:\n\n* Smoking\n\nUncontrolled systemic disease\n\nPresence of infection in the area\n\nUse of medications affecting bone metabolism\n\nPregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT07031895', 'acronym': 'socket healing', 'briefTitle': 'The Effectiveness of Hyaluronic Acid in Bone Regeneration', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'Evaluation of the Efficacy of Xenograft Containing Hyaluronic Acid in Socket Preservation Procedure Radiologically and Histologically: A Prospective Randomized Controlled Clinical Study', 'orgStudyIdInfo': {'id': '2025/184-F'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bovine-derived graft/xenograft enriched with hyaluronic acid study group', 'description': 'Study group - Patients whose alveolar bone is pre-evaluated using cone-beam computed tomography (CBCT) will receive a bovine-derived graft/xenograft enriched with hyaluronic acid in the extraction socket after tooth removal. Patients will be evaluated clinically, radiologically, and histologically at 4 months. Dental implants will be placed in the edentulous areas where the graft was applied. Bone samples will be collected during the preparation of the implant sockets and analyzed histologically. A third CBCT scan will be performed 6 months after implant placement to radiographically assess new bone formation and implant success.', 'interventionNames': ['Combination Product: a bovine-derived graft/xenograft enriched with hyaluronic acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard bovine-derived graft/xenograft comparison group', 'description': 'Comparison group - Patients whose alveolar bone is pre-evaluated using CBCT will receive a standard bovine-derived graft/xenograft in the extraction socket after tooth removal. Patients will be evaluated clinically, radiologically, and histologically at 4 months. Dental implants will be placed in the grafted areas. Bone samples will be collected during implant socket preparation and analyzed histologically. A third CBCT scan will be performed 6 months after implant placement to assess new bone formation and implant success.', 'interventionNames': ['Combination Product: a standart bovine-derived graft/xenograft']}, {'type': 'NO_INTERVENTION', 'label': 'Control group without graft material', 'description': 'Control group - Patients whose alveolar bone is pre-evaluated using CBCT will undergo tooth extraction without graft material application, allowing for natural healing of the socket. Patients will be evaluated clinically, radiologically, and histologically at 4 months. Dental implants will be placed in the edentulous areas. Bone samples will be collected during the preparation of the implant sockets and analyzed histologically. A third CBCT scan will be performed 6 months after implant placement to assess new bone formation and implant success.'}], 'interventions': [{'name': 'a bovine-derived graft/xenograft enriched with hyaluronic acid', 'type': 'COMBINATION_PRODUCT', 'description': 'In study group a bovine-derived graft/xenograft enriched with hyaluronic acid will be placed in the extraction socket after tooth removal.', 'armGroupLabels': ['Bovine-derived graft/xenograft enriched with hyaluronic acid study group']}, {'name': 'a standart bovine-derived graft/xenograft', 'type': 'COMBINATION_PRODUCT', 'description': 'In comparison group a standard bovine-derived graft/xenograft will be placed in the extraction socket after tooth removal.', 'armGroupLabels': ['Standard bovine-derived graft/xenograft comparison group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Duygu Kılıç, PhD', 'role': 'CONTACT', 'email': 'duygukilic4838@gmail.com', 'phone': '+903522076600'}], 'overallOfficials': [{'name': 'Duygu Kılıç, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Erciyes University Faculty of Dentistry Department of Periodontology'}, {'name': 'Fidan Gulıyeva, Research Assistant', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erciyes University Faculty of Dentistry Department of Periodontology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We do not wish to share data due to the possibility that patients may not consent to the sharing of personal information.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TC Erciyes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Duygu Kilic', 'investigatorAffiliation': 'TC Erciyes University'}}}}