Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:04 AM
Study NCT ID:
NCT07442604
Status:
COMPLETED
Last Update Posted:
2026-03-02
First Post:
2026-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implant Stability Changes Using Different Technique in Posterior Maxilla With Early Loading Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016388', 'term': 'Tooth Loss'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2026-02-24', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implant stability', 'timeFrame': '2 months', 'description': 'Implant stability was assessed at the time of implant insertion, 1 month and 2 months after surgery. The analysis of resonance frequency analysis (RFA) was made using an Osstell Mentor apparatus. The smart peg was attached to the dental implant. The RFA value was measured 4 times in 4 directions (every 90°). The results were expressed as implant stability quotient (ISQ) and averaged for each implant. The ISQ scale ranges from 0 to 100. The values less than 60 indicate low implant stability, values from 60 to 69 indicate medium stability, while values from 70 to 79 indicate high stability.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tooth Loss']}, 'descriptionModule': {'briefSummary': '60 implants were placed in patients seeking implantation of their lost posterior maxillary teeth (premolar and molars) with normal bone height beneath the floor of the maxillary sinus. The patients were selected from those attending the outpatient clinic of the Oral \\& Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University.\n\n60 implants will be randomly and uniformly divided into two equal groups: Group 1: It was consisted of 20 inserted dental implants by Densah burs into healed posterior maxillary alveolar ridge with an early loading pattern.\n\nGroup 2: It was consisted of 20 inserted dental implants by Magnetic Mallet technique into healed posterior maxillary alveolar ridge with an early loading pattern.\n\nGroup 3: It was consisted of 20 inserted dental implants by Conventional Drilling technique into healed posterior maxillary alveolar ridge with an early loading pattern.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient with missing one or more posterior maxillary teeth.\n2. Patients in the age group between 18 and 60 years old.\n3. 10 mm or more vertical bone height is present.\n4. No gender preface in selection of the patients.\n5. Good oral hygiene.\n6. Non-smokers.\n7. Patients willing to be present during the study follow up intervals.\n8. Patients free from any systemic diseases.\n9. 6 mm or more ridge width is present.\n10. Crown height space of at least 8 mm.\n11. Patients without any para-functional habits (bruxism and clenching).\n\nExclusion Criteria:\n\n1. Patients with any pathological lesion or root tips at the planned surgical site.\n2. Patients with systemic diseases that contra-indicate the surgical procedure or affect bone healing process such as uncontrolled diabetes mellitus, bleeding disorders, serious osseous disorders, and mental disorders.\n3. Patient taking drugs that could affect bone healing process as in immunosuppressive drugs and bisphosphonates.\n4. Alcoholism.\n5. Untreated periodontal disease or bad oral hygiene.\n6. Pregnancy.'}, 'identificationModule': {'nctId': 'NCT07442604', 'briefTitle': 'Implant Stability Changes Using Different Technique in Posterior Maxilla With Early Loading Protocol', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Implant Stability Changes Using Densah Burs Versus Magnetic Mallet Technique in Posterior Maxilla With Early Loading Protocol: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'R.26.01.101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Densah burs group', 'interventionNames': ['Procedure: Densah burs']}, {'type': 'EXPERIMENTAL', 'label': 'Magnetic Mallet group', 'interventionNames': ['Procedure: Magnetic Mallet technique']}, {'type': 'EXPERIMENTAL', 'label': 'Conventional Drilling group', 'interventionNames': ['Procedure: Conventional Drilling technique']}], 'interventions': [{'name': 'Densah burs', 'type': 'PROCEDURE', 'description': '20 inserted dental implants by Densah burs into healed posterior maxillary alveolar ridge with an early loading pattern.', 'armGroupLabels': ['Densah burs group']}, {'name': 'Magnetic Mallet technique', 'type': 'PROCEDURE', 'description': '20 inserted dental implants by Magnetic Mallet technique into healed posterior maxillary alveolar ridge with an early loading pattern.', 'armGroupLabels': ['Magnetic Mallet group']}, {'name': 'Conventional Drilling technique', 'type': 'PROCEDURE', 'description': '20 inserted dental implants by Conventional Drilling technique into healed posterior maxillary alveolar ridge with an early loading pattern.', 'armGroupLabels': ['Conventional Drilling group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '002', 'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Heba elsheikh', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}