Evaluation of Implant Stability Following Maxillary Sinus Floor Elevation Through Piezoelectric Trans-crestal Approach Versus Crestal Implant Approach

Evaluation of Implant Stability Following Maxillary Sinus Floor Elevation Through Piezoelectric Trans-crestal Approach Versus Crestal Implant Approach: A 1-year Randomized Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Internal Sinus Lifting
• Intervention / Treatment: Procedure: Crestal implant approach; Procedure: PISE

Detailed Description

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.

Hypothesis:

Research 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.

The primary objective:

• 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)

The secondary objectives:

• To assess intra-sinus vertical bone gain around dental implants, in mm, will be assessed by CBCT.
• To assess marginal bone level, in mm
• To assess peri-implant soft tissue parameters by modified plaque and bleeding indices.
• To evaluate post-operative pain.
• To assess any surgical or post-surgical complications.

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nourhan G Dr. Nourhan Gamal; Phone Number: 01064249441; Email: Nourhannegamal259@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who have at least one missing posterior maxillary tooth with sound adjacent and opposing dentition.
• Adults above the age of 21.
• Bone height from 4mm to 6mm under the maxillary sinus assessed in CBCT.
• Good oral hygiene.
• Patient accepts to provide an informed consent.

Exclusion Criteria:

• Smokers.
• Pregnant and lactating females.
• Medically compromised patients.
• Patients with untreated active periodontal diseases.
• Patients with active infection related to the implant site.
• Patients with parafunctional habits.
• Patients with Acute or chronic sinusitis.
• Presence of sinus septa
• History of radiotherapy or chemotherapy within the past 2 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cerstal implant Approach; 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).	Procedure: Crestal implant approach; 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
Experimental: PISE; 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).	Procedure: PISE; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra Sinus bone formation	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	1 year

Collaborators and Investigators

• Sponsor: International Dental Contiuing Education

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: implant stability; crestal implant approach; PISE
• Other Study ID Numbers: IDCE-41722026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No