Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-31 @ 3:48 PM
Study NCT ID:
NCT07104994
Status:
COMPLETED
Last Update Posted:
2025-08-05
First Post:
2025-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inferior Alveolar Nerve Translocation With Dental Implant Placement in Severely Resorbed Mandibles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015921', 'term': 'Dental Implants'}], 'ancestors': [{'id': 'D003764', 'term': 'Dental Materials'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D017266', 'term': 'Dental Prosthesis'}, {'id': 'D011476', 'term': 'Prosthodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-06-14', 'size': 179720, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-01T09:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2025-07-22', 'studyFirstSubmitQcDate': '2025-08-01', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cone-beam Computed Tomography (CBCT)', 'timeFrame': "The implant's success rate was determined by primary stability during insertion, assessed by ratchet, and then confirmed by X-ray. CBCTs were taken at 3 months and 4 months after implant insertion to check for marginal bone loss.", 'description': 'visualize the inferior alveolar canal (IAC) and assess the proximity of the implant to the nerve'}], 'secondaryOutcomes': [{'measure': 'Subjective Function Score', 'timeFrame': 'Neurosensory evaluation was carried out on the 1st and 7th postoperative day and every month thereafter for up to 6 months.', 'description': 'Patients rate their perceived sensory function relative to an unaffected area, providing a measure of functional impairment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inferior Alveolar Nerve', 'Mandibular Atrophy', 'Dental Implant', 'Alveolar Ridge Resorption'], 'conditions': ['Sever Mandibular Bone Resorption', 'Sensory Defect', 'Implant Failure']}, 'referencesModule': {'references': [{'pmid': '41388273', 'type': 'DERIVED', 'citation': 'Hwaiti HS, Al-Rubidi YA, Al-Ashwal A, Al-Hadi Y, Al-Kibsi T, Al-Wesabi MA. Inferior alveolar nerve relocation and immediate dental implant placement in severely resorbed mandibles: a prospective clinical case series. BMC Oral Health. 2025 Dec 13. doi: 10.1186/s12903-025-07492-z. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'This study investigates the effects of inferior alveolar nerve lateralization on the post-implant insertion sensory outcome for patients with severe mandibular bone resorption.', 'detailedDescription': "This is a prospective randomized clinical trial. The study was carried out in patients with posterior mandibular atrophies among selected cases from patients attending the Faculty of Dentistry dental polyclinics, and some private dental clinics in Sana'a city The age of patients was above the age of 18 years All patients received a thorough dental examination (extra-oral and intra-oral examination) in dental clinics using a dental mirror, ball-tipped World Health Organization (WHO) dental prob, and dental tweezers. Sterile examination tools by autoclave class B were used. Clinical examination included Oral health and oral hygiene status, interarch distance, dimensions of the edentulous ridge, and soft tissue condition. Panoramic radiographs were taken to assess the condition of the patients' teeth and jawbone, as well as to detect any oral infections requiring treatment. Surgical procedures are performed to translocate the inferior alveolar nerve to provide a good space for implant insertion. All cases ahs undergone follow-up for post-surgical sensory disturbances."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- All other patients\n\nExclusion Criteria:\n\n* Patients with active infections, uncontrolled diabetes, history of radiotherapy, chemotherapy, or oral cancer surgery were excluded from this study'}, 'identificationModule': {'nctId': 'NCT07104994', 'briefTitle': 'Inferior Alveolar Nerve Translocation With Dental Implant Placement in Severely Resorbed Mandibles', 'organization': {'class': 'OTHER', 'fullName': 'University of Science and Technology, Yemen'}, 'officialTitle': 'Inferior Alveolar Nerve Lateralization and Immediate Dental Implant Placement in Severely Resorbed Mandibles: A Clinical Trial', 'orgStudyIdInfo': {'id': 'OMFS:14/06/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dental implant group', 'interventionNames': ['Device: Dental implant']}], 'interventions': [{'name': 'Dental implant', 'type': 'DEVICE', 'description': 'insertion of dental implants after surgical tranlocation of the inferior alveolar nerve.', 'armGroupLabels': ['Dental implant group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aden', 'country': 'Yemen', 'facility': 'University of Science and technology', 'geoPoint': {'lat': 12.77957, 'lon': 45.03852}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Science and Technology, Yemen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mohammed Ali Al-wesabi', 'investigatorAffiliation': 'University of Science and Technology, Yemen'}}}}