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NCT Number: NCT07433868

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

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.

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Key information

Conditions

Internal Sinus Lifting

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PISE

Procedure

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

Crestal implant approach

Procedure

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

Primary outcomes

  1. Intra Sinus bone formation

    Time frame: 1 year

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Nourhan G Dr. Nourhan Gamal

CONTACT

[email protected]

01064249441

Sponsors and collaborators

Lead sponsor

International Dental Contiuing Education

Network

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 25, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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