Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 8:55 PM
Study NCT ID:
NCT07452068
Status:
COMPLETED
Last Update Posted:
2026-03-05
First Post:
2025-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Intrasinus and Extrasinus Approach for the Placement of Zygomatic Implants in Severely Resorbed Edentulous Maxillary Arch Using Zygomatic Success Code - An In-Vivo Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2024-12-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-01', 'studyFirstSubmitDate': '2025-02-04', 'studyFirstSubmitQcDate': '2026-03-01', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Zygomatic implant stability', 'timeFrame': 'Implant stability was evaluated individually after 3 and 6 months of implant placement and prosthetic rehabilitation', 'description': 'When extra-sinus and intra-sinus placed implants are tested individually, slight mobility should be detected with no other associated pathological signs. Instrument used for checking the implant stability is periotest.\n\nMobility of the implant comes from the elastic modulus of the anchoring zygomatic bone when they are bent by a remotely applied force. On the other hand, the movement must not be rotational, and it will disappear when implants are splinted together. A rotational movement should be considered as a sign of implant failure. Grade I- no mobility, no pain Grade II-light clinical mobility, no pain Grade III-clear clinical mobility, no pain (no evidence of disintegration of the apical part of the implant or rotation Grade IV- clear clinical mobility, rotation and pain evidence of disintegration of apical part of the implant)'}], 'secondaryOutcomes': [{'measure': 'Associated sinus pathology', 'timeFrame': 'Associated sinus pathologywas assessed at 3 and 6 months after implant placement', 'description': 'Frequently associated complications such as rhinitis and sinusitis were assessed by two scoring systems: Lund-Mackay staging and the Lanza and Kennedy score.\n\nLund-Mackay stating and Lanza and Kennedy score\n\nThis system scored six sinus regions: anterior ethmoid, posterior ethmoid, maxillary sinus, frontal sinus, sphenoid sinus, and osteomeatal complex for sinus pathology. The score 0 represented no abnormality; 1 represented partial opacification; and 2 represented total opacification. For the osteomeatal complex, the score was either 0 or 2. This scoring was done for pre-operative and post-operative evaluation.\n\nLanza-Kennedy - Rhinosinusal Clinical Symptoms\n\nIt is patient-related questionnaire to identify the rhinosinusal clinical symptoms. Each symptom\n\nquestion is answered by "yes" or "no". The diagnosis of sinusitis requires a "yes" answer in two or more major criteria, one major and two or more minor criteria, or purulence on nasal examination'}, {'measure': 'Peri-Implant Soft Tissue Condition', 'timeFrame': 'Soft tissue around the zygomatic implant was assessed at 3 and 6 months', 'description': 'Soft tissue around the zygomatic implant was assessed at 3 and 6 months after implant placement and prosthetic replacement, where the exposed implant surface was measured from the implant head to the soft tissue recession area.'}, {'measure': 'Prosthetic Offset', 'timeFrame': 'Prosthetic Offset assessed at 3 and 6 months', 'description': 'Prosthetic success depends on the anatomic measurements to assess the implant position of the head of the zygomatic implant.\n\nFour anatomical measurements will be performed to assess the following:\n\n1. Perpendicular distance between the tangent to the floor of the nose and sinus floor at the entrance of the zygomatic implant level.\n2. Perpendicular distance between the tangent to the floor of the nose and the crest of the alveolar ridge at the entrance of the zygoma implant level.\n\n i. The height of the alveolar ridge at the location of the head of the zygomatic implant (measurement 2 minus 1)\n3. Distance between the midline of the palate and the center of the zygomatic implant head.\n4. Distance between the midline of the palate and the center of the alveolar ridge.\n\nii. The position of the head of the zygomatic implants with regard to the center of the crest of the alveolar ridge in the horizontal axial dimension (measurement 4 minus 3).\n\nA positive value on this implant head position'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Implant Stability']}, 'descriptionModule': {'briefSummary': 'Various approach has outlined in the literature but no clinical studies that have compared the intrasinus and extrasinus approach for the placement of zygomatic implants using zygomatic success code.\n\nThe present study is planned to compare the intrasinus and extrasinus approach for the placement of zygomatic implant in severely resorbed edentulous maxillary arch using zygomatic success code.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': "INCLUSION CRITERIA\n\n* Completely edentulous maxilla.\n* Both gender without any systemic disease.\n* Patients with Misch-Type III edentulous maxillary arch and with Seibert's Class III ridge.\n* ZAGA-4 patients (pronounced buccal concavities of the maxilla).\n\nEXCLUSION CRITERIA\n\n* Any systemic illness/medications\n* Radiation therapy to the head and neck region 12 months prior to the proposed therapy.\n* Smoking\n* Pregnant and lactating women\n* Drug allergy\n* Bisphosphonates medication\n* Alcohol/ drug addiction\n* Maxillary sinusitis"}, 'identificationModule': {'nctId': 'NCT07452068', 'briefTitle': 'Comparison of Intrasinus and Extrasinus Approach for the Placement of Zygomatic Implants in Severely Resorbed Edentulous Maxillary Arch Using Zygomatic Success Code - An In-Vivo Study', 'organization': {'class': 'OTHER', 'fullName': 'Postgraduate Institute of Dental Sciences Rohtak'}, 'officialTitle': 'Comparison of Intrasinus and Extrasinus Approach for the Placement of Zygomatic Implants in Severely Resorbed Edentulous Maxillary Arch Using Zygomatic Success Code - An In-Vivo Study', 'orgStudyIdInfo': {'id': 'Dhanavath Prabhavathi'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'INTRASINUS', 'description': 'PARAMETERS ASSESED:\n\n1. IMPLANT STABILITY\n2. SINUS PATHOLOGY\n3. SOFT TISSUE CONDITIONING\n4. PROSTHETIC OFFSET 18 SAMPLES INCLUDED', 'interventionNames': ['Procedure: ZYGOMATIC IMPLANT KIT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EXTRASINUS', 'description': 'PARAMETERS ASSESED:\n\n1. IMPLANT STABILITY\n2. SINUS PATHOLOGY\n3. SOFT TISSUE CONDITIONING\n4. PROSTHETIC OFFSET 18 SAMPLES INCLUDED', 'interventionNames': ['Procedure: ZYGOMATIC IMPLANT KIT']}], 'interventions': [{'name': 'ZYGOMATIC IMPLANT KIT', 'type': 'PROCEDURE', 'description': 'CRESTAL INCISION FROM TUBEROSITY TO TUBEROSITY AND REFLECT THE FLAP . OSTEOTOMY DONE FROM MOLAR TO ZYGOMATIC BONE.IMPLANT PLACEMENT DONE', 'armGroupLabels': ['EXTRASINUS', 'INTRASINUS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '124001', 'city': 'Rohtak', 'state': 'Haryana', 'country': 'India', 'facility': 'PGIDS', 'geoPoint': {'lat': 28.89447, 'lon': 76.58917}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Postgraduate Institute of Dental Sciences Rohtak', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}