Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:32 AM
Study NCT ID:
NCT07433868
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Implant Stability Following Maxillary Sinus Floor Elevation Through Piezoelectric Trans-crestal Approach Versus Crestal Implant Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Evaluation Day:\n\nPatients Enrollment:\n\nFor the patients who meet eligibility criteria, the PI will explain the study procedures in details and the informed consent form will be offered in a private area assigned by the IDCE management. The PI will answer all questions the patients have, and after signing the informed consent, patients will be referred to perform CBCT on the same visit.\n\nPreoperative procedure:\n\n• After patient enrollment, a preoperative CBCT will be performed for each participant prior to the surgery for precise evaluation of residual ridge height, sinus anatomy.\n\no Surgery Day (T0): After administration of local anesthesia, the allocation will be revealed; Group 1 (Test): Implant placement with PISE Group 2 (Control): Implant placement with crestal implant approach'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-02-19', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intra Sinus bone formation', 'timeFrame': '1 year', 'description': 'Four CBCT scans will be done scans; at T0, T1, T2 \\& T4, using Cranex® SOREDEX, Finland, Commercially available at ORASCAN oral and maxillofacial imaging centre, Cairo, Egypt, and at the outpatient clinics of faculty of dentistry, Misr International University, Cairo, Egypt. Standardization of the exposure parameters: Field of view 6 x 8 cm, peak kilovoltage of 90 Kv, milliamperage of 10 mA, exposure time of 6.1 seconds and resolution of 0.2 mm (200 μm) voxel size. All data from CBCT examinations will be acquired in a DICOM format which is imported to OnDemand3D ® App software (Cybermed, Seoul, Korea). In order to ensure standardization and reproducibility of the CBCT cross sectional images that will be used in this study, superimposition of DICOM sets of each patient using Fusion module of Ondemand 3D App software will be done. This 3D superimposition technique allows for sub-voxel accuracy and highly strong registration. Both files will be loaded in the Fusion module at the same tim'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['crestal implant approach', 'PISE', 'implant stability'], 'conditions': ['Internal Sinus Lifting']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'ALBREKTSSON, T. 1993. On long-term maintenance of the osseointegrated response. Aust Prosthodont J, 7 Suppl, 15-24. ALBREKTSSON, T., ZARB, G., WORTHINGTON, P. & ERIKSSON, A. R. 1986. The long-term efficacy of currently used dental implants: A review and proposed criteria of success. The International journal of oral & maxillofacial implants, 1, 11-25. BALDI, D., MENINI, M., PERA, F., RAVERA, G. & PERA, P. 2011. Sinus floor elevation using osteotomes or piezoelectric surgery. Int J Oral Maxillofac Surg, 40, 497-503. BECHARA, S., KUBILIUS, R., VERONESI, G., PIRES, J. T., SHIBLI, J. A. & MANGANO, F. G. 2017. Short (6-mm) dental implants versus sinus floor elevation and placement of longer (≥10-mm) dental implants: a randomized controlled trial with a 3-year follow-up. Clin Oral Implants Res, 28, 1097-1107. BISHBISH, O., KAN, J. & KIM, Y. J. 2023. Guided Lateral Window Osteotomy Using Dynamic Navigation for Maxillary Sinus Augmentation: A Novel Technique. J Oral Implantol, 49, 316-321. BOYNE, P. J. & JAMES, R. A. 1980. Grafting of the maxillary sinus floor with autogenous marrow and bone. J Oral Surg, 38, 613-6. DRAGONAS, P., PRASAD, H. S., YU, Q., MAYER, E. T. & FIDEL, P. L., JR. 2023. Bone Regeneration in Maxillary Sinus Augmentation Using Advanced Platelet-Rich Fibrin (A-PRF) and Plasma Rich in Growth Factors (PRGF): A Pilot Randomized Controlled Trial. Int J Periodontics Restorative Dent, 43, 319-327. FETTOUH, A. I. A., GHALLAB, N. A., ADEL, N., NASSER, R., GAMAL, N., SAMY, M. & SHEMAIS, N. 2026. Graftless Sinus Floor Elevation Using the Lateral or Transcrestal Approach. A Randomized Clinical Trial With One Year Follow-Up. Clin Oral Implants Res, 37, 87-97. FETTOUH, A. I. A., GHALLAB, N. A., GHAFFAR, K. A., MINA, N. A., ABDELMALAK, M. S., ABDELRAHMAN, A. A. G. & SHEMAIS, N. M. 2023. Bone dimensional changes after flapless immediate implant placement with and without bone grafting: Randomized clinical trial. Clin Implant Dent Relat Res, 25, 271-283. FETTOUH, A. I. A.'}]}, 'descriptionModule': {'briefSummary': "Rehabilitation of the maxillary posterior region is a challenge in every-day clinical practice. Following extraction of maxillary molars, alveolar ridge atrophy along with maxillary sinus pneumatization decrease the bone volume and increase implant placement complexity (Lyu et al., 2023). Several surgical procedures have been proposed to overcome these complications, including; short implants (Bechara et al., 2017), tilted implants (Meng and Zhang, 2022) as well as different sinus floor elevation techniques (Irinakis, 2011, Bishbish et al., 2023, Dragonas et al., 2023). Crestal maxillary sinus floor elevation has been considered a predictable and less invasive approach, providing sufficient vertical ridge height with high rates of implant survival (Guruprasad et al., 2024). However, there's limited body of evidence comparing the efficacy of different trans-crestal approaches as PISE and crestal implant approach with no bone graft. Thus, further clinical trials are recommended to determine whether the adjunctive use of piezoelectric instrumentation in internal sinus elevation offers significant clinical advantages over the crestal implant approach.", 'detailedDescription': 'Aim of the study: The aim of this study is to evaluate clinical long term implant stability and radiographic vertical bone height gain after implant placement in posterior maxilla using crestal implant approach in comparison to PISE.\n\nHypothesis:\n\nResearch Null hypothesis: There will be no difference between implants placed with crestal implant approach and PISE, regarding long term implant stability and radiographic bone height gain.\n\nThe primary objective:\n\n• To compare the implant stability quotient (ISQ) between the two treatment modalities, will be assessed by resonance frequency analysis using "Osstell" (Integration Diagnostics, Save Dalen, Sweden)\n\nThe secondary objectives:\n\n* To assess intra-sinus vertical bone gain around dental implants, in mm, will be assessed by CBCT.\n* To assess marginal bone level, in mm\n* To assess peri-implant soft tissue parameters by modified plaque and bleeding indices.\n* To evaluate post-operative pain.\n* To assess any surgical or post-surgical complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have at least one missing posterior maxillary tooth with sound adjacent and opposing dentition.\n* Adults above the age of 21.\n* Bone height from 4mm to 6mm under the maxillary sinus assessed in CBCT.\n* Good oral hygiene.\n* Patient accepts to provide an informed consent.\n\nExclusion Criteria:\n\n* Smokers.\n* Pregnant and lactating females.\n* Medically compromised patients.\n* Patients with untreated active periodontal diseases.\n* Patients with active infection related to the implant site.\n* Patients with parafunctional habits.\n* Patients with Acute or chronic sinusitis.\n* Presence of sinus septa\n* History of radiotherapy or chemotherapy within the past 2 years'}, 'identificationModule': {'nctId': 'NCT07433868', 'briefTitle': 'Evaluation of Implant Stability Following Maxillary Sinus Floor Elevation Through Piezoelectric Trans-crestal Approach Versus Crestal Implant Approach', 'organization': {'class': 'NETWORK', 'fullName': 'International Dental Contiuing Education'}, 'officialTitle': 'Evaluation of Implant Stability Following Maxillary Sinus Floor Elevation Through Piezoelectric Trans-crestal Approach Versus Crestal Implant Approach: A 1-year Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'IDCE-41722026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cerstal implant Approach', 'description': "a mid-crestal incision will be done using a 15c blade (Carl Martin GmbH, Solingen, Germany) and then a full thickness mucoperiosteal flap will be elevated. Osteotomy site preparation and implant drilling sequence were performed according to the manufacturer's instructions. Drilling will be done gently till reaching 0.5-1mm from the sinus floor, checked by periapical radiographs with the drills placed in the osteotomy. During implant placement, the sinus membrane will be gently elevated with the blunt rounded circular apex of the implant (MegaGen AnyRidge®, MegaGen Implant Co., Ltd., Daegu, South Korea) as previously described by Fettouh et al. (2024).", 'interventionNames': ['Procedure: Crestal implant approach']}, {'type': 'EXPERIMENTAL', 'label': 'PISE', 'description': 'a mid-crestal incision will be done using a 15c blade (Carl Martin GmbH, Solingen, Germany) and then a full thickness mucoperiosteal flap will be elevated. Osteotomy site preparation will be initiated using a piezoelectric ultrasonic osteotome under sterile irrigation. Sequential osteotomy preparation will be carried out while maintaining the planned implant angulation 1 mm short of the sinus floor based on preoperative radiographic measurements done using the CBCT. Thinning the sinus floor will be achieved after using subsequent widening drills and the integrity of the Schneiderian membrane and the residual bone thickness will be verified using periapical radiographs to ensure the exact amount of remaining floor bone (Baldi et al., 2011). According to the pre-planned prosthetic implant position, the implant will be placed (MegaGen Implant Co., Ltd., Daegu, South Korea).', 'interventionNames': ['Procedure: PISE']}], 'interventions': [{'name': 'PISE', 'type': 'PROCEDURE', 'description': 'Osteotomy site preparation will be initiated using a piezoelectric ultrasonic osteotome under sterile irrigation. Sequential osteotomy preparation will be carried out while maintaining the planned implant angulation 1 mm short of the sinus floor based on preoperative radiographic measurements done using the CBCT. Thinning the sinus floor will be achieved after using subsequent widening drills and the integrity of the Schneiderian membrane and the residual bone thickness will be verified using periapical radiographs to ensure the exact amount of remaining floor bone', 'armGroupLabels': ['PISE']}, {'name': 'Crestal implant approach', 'type': 'PROCEDURE', 'description': "Osteotomy site preparation and implant drilling sequence were performed according to the manufacturer's instructions. Drilling will be done gently till reaching 0.5-1mm from the sinus floor, checked by periapical radiographs with the drills placed in the osteotomy. During implant placement, the sinus membrane will be gently elevated with the blunt rounded circular apex of the implant", 'armGroupLabels': ['Cerstal implant Approach']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nourhan G Dr. Nourhan Gamal', 'role': 'CONTACT', 'email': 'Nourhannegamal259@gmail.com', 'phone': '01064249441'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Dental Contiuing Education', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}