Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2026-01-05 @ 5:22 PM
Study NCT ID:
NCT06842368
Status:
RECRUITING
Last Update Posted:
2025-02-24
First Post:
2025-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immediate Implant Placement Using Xenograft Mixed with Vitamin D Versus Hyaluronic Acid.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006820', 'term': 'Hyaluronic Acid'}, {'id': 'D014807', 'term': 'Vitamin D'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Each patient will be given a code by the researcher and the observers will be blind to which group this case belong. Patients, radiographic outcome assessor and statistician will be blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Clinical Trial. Parallel group study. Allocation Ratio 1:1.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-19', 'studyFirstSubmitDate': '2025-02-03', 'studyFirstSubmitQcDate': '2025-02-19', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implant secondary stability', 'timeFrame': 'after 6 months', 'description': 'To evaluate the implant stability by Any-check device.'}], 'secondaryOutcomes': [{'measure': 'Density of bone around implant', 'timeFrame': 'after 6 months', 'description': 'Cone beam computed tomography CBCT'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hyaluronic acid', 'Vitamin D', 'Xenograft', 'Immediate Implant'], 'conditions': ['Immediate Implant Placement']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Abd Elwahap, Mohammad et al. "Effect of Xenograft Alone versus Xenograft Mixed with Vitamin-D On Preservation of Alveolar Sockets of Chronically Infected Teeth." Al-Azhar Journal of Dental Science (2024): n. pag.'}, {'type': 'BACKGROUND', 'citation': '⦁ Elgazzar, A., Yousef, E., Amer, M. Effect of Hyaluronic Acid Mixed with Biphasic Calcium Phosphate on Bone Healing Around Immediately Placed Implants in the Posterior Area of the Mandible. Egyptian Dental Journal, 2023; 69(4): 2631-2641. doi: 10.21608/edj.2023.227200.2669'}]}, 'descriptionModule': {'briefSummary': 'Immediate implant placement using xenograft as space filling material mixed with vitamin D versus hyaluronic acid in posterior mandible region This study aims to evaluate implant stability and density after placement of immediate implant and Xenograft mixed with Hyaluronic acid or Vitamin D at posterior mandible region', 'detailedDescription': 'Dental implants in fresh extraction sockets and healed sites have a erratic morphology, creating a wide space defect between the implant and buccal alveolar bone. This defect is critical for implant success, known as a jumping gap. Proper management of this space is essential for esthetic and functional success. Studies show adequate bone fill can be achieved in jumping gaps, but wider gaps increase implant body exposure risk.\n\nThe application of biological mediators embedded in the biomaterial can induce specific cell and tissue response, which can improve bone quality and quantity. Dental research has focused on improving bone substitutes by morphologic or bio- chemical modification.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nAge: 18-60.\n\n* Systemically healthy patients indicated for single or multiple immediate implants in posterior teeth region.\n* Absence of any peri-apical pathosis.\n* Patients with intact buccal plate of bone.\n* Patients with adequate bone volume for the dental implant procedure.\n* Patient with good oral hygrine\n\nExclusion Criteria:\n\n* Heavy Smokers.\n* Systemic disease that may affect the final outcome of the surgical procedure.\n* No or poor patient's compliance.\n* Patients with psychological problems.\n* Pathology at the site of intervention.\n* Patient with vit d deficiency"}, 'identificationModule': {'nctId': 'NCT06842368', 'briefTitle': 'Immediate Implant Placement Using Xenograft Mixed with Vitamin D Versus Hyaluronic Acid.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Immediate Implant Placement Using Xenograft As Space Filling Material Mixed with Vitamin D Versus Hyaluronic Acid in Posterior Mandible Region: a Randomized Controlled Clinical Trial.', 'orgStudyIdInfo': {'id': 'A.M.A.E'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin D mixed with Xenograft as space filling material after placement of immediate implant.', 'description': 'Careful extraction of the selected tooth will initiated using sharp periotome to sever the periodontal ligament attachments while preserving the surrounding alveolar bone and interdental papilla and followed by using extraction forceps. Meticulous mechanical debridement of the extraction socket will be carried out using bone curette to remove any soft tissue remnants or granulation tissue. All debris will washed out using copious saline irrigation. Implant osteotomy will then initiated engaging the furcation of the alveolus along with the remaining apical bone and while maintain jumping gap more than 2 mm between the implant platform and the alveolar. the jumping space will packed using Xenograft with particle size ranging from 0.25 to 1 mm and it will be mixed with Vitamin D and the socket will sealed using 4-0 resorbable sutures.', 'interventionNames': ['Procedure: Vitamin D']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hyaluronic acid mixed with Xenograft as space filling material after placement of immediate implant.', 'description': 'Careful extraction of the selected tooth will initiated using sharp periotome to sever the periodontal ligament attachments while preserving the surrounding alveolar bone and interdental papilla and followed by using extraction forceps. Meticulous mechanical debridement of the extraction socket will be carried out using bone curette to remove any soft tissue remnants or granulation tissue. All debris will washed out using copious saline irrigation. Implant osteotomy will then initiated engaging the furcation of the alveolus along with the remaining apical bone and while maintain jumping gap more than 2 mm between the implant platform and the alveolar. the jumping space will packed using Xenograft with particle size ranging from 0.25 to 1 mm and it will be mixed with hyaluronic acid and the socket will sealed using 4-0 resorbable sutures.', 'interventionNames': ['Procedure: Hyaluronic Acid (HA)']}], 'interventions': [{'name': 'Hyaluronic Acid (HA)', 'type': 'PROCEDURE', 'description': 'Hyaluronic acid is one of the essential components of extracellular matrix, which plays a predominant role in tissue morphogenesis, cell migration, differentiation, and adhesion. It has been recently reported that hyaluronic acid increases osteoblastic bone formation in vitro through increased mesenchymal cell differentiation and migration.\n\nIt has demonstrated that Hyaluronic acid not only acted as a carrier of growth factors and cell but also stimulated bone formation through chemotaxis, proliferation and differentiation of mesenchymal cells into osteoblasts.\n\nAlthough Hyaluronic acid shares bone induction properties with growth factors as bone morphogenic protein 2 and osteopontin', 'armGroupLabels': ['Hyaluronic acid mixed with Xenograft as space filling material after placement of immediate implant.']}, {'name': 'Vitamin D', 'type': 'PROCEDURE', 'description': 'It was shown that locally applied vitamin D3 in combination with bovine bone mineral matrix improved the bone formation and strengthened the site of the fracture in ovariectomized rats.\n\nLocal application of vitamin D3 also proved to be promising in promoting osteo- genesis and mineralization for restoration of bone defects. Grounding on this incites, it has been suggested that vitamin D3 might exert a positive local effect on alveolar bone regeneration', 'armGroupLabels': ['Vitamin D mixed with Xenograft as space filling material after placement of immediate implant.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Faculty of dentistry ,Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'AMMAR EIZ EDDIN', 'role': 'CONTACT', 'email': 'ammar.adib@dentistry.cu.edu.eg', 'phone': '00201153383058'}, {'name': 'MOHAMED ASHRAF, phD', 'role': 'CONTACT', 'email': 'mohamed-ashraf@dentistry.cu.edu.eg', 'phone': '00201111186256'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Master's degree candidate", 'investigatorFullName': 'Ammar Mohamad Adib Eiz Eddin', 'investigatorAffiliation': 'Cairo University'}}}}