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Recruiting Not applicable

Osseodensification Versus Osteotome Internal Sinus Lifting in Delayed Implant Placement

NCT05495490 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2026-02-10
Last updated
2026-01-21

Condition(s) studied

Maxillary Sinus Floor Augmentation

Investigational drug(s) / intervention(s)

Osseodensification Internal Sinus LiftOsteotome Internal Sinus Lift

Osseodensification Internal Sinus Lift: The osteotomy for the Osseodensification internal sinus lift begins with the advancement of a twist drill at 800 rpm and saline irrigation to within 1-2 mm of the sinus floor. The osteotomy is then widened by employing a series of osteotomy drills rotating at 800 rpm. Infracture of the sinus has occurred when the final osteotomy drill is advanced with gentle pressure at 100 rpm counterclockwise without irrigation until a bouncing sensation ("haptic feedback") occurs. After infracture, the graft material will be injected into the osteotomy site. Using the final osteotomy drill, the graft is guided apically. This procedure is repeated incrementally to raise the membrane. Once sufficient space has been created beneath the antral membrane, the implant will be inserted followed by suturing.

Osteotome Internal Sinus Lift: The osteotomy for the Osteotome internal sinus lift will begin with standard drills and saline irrigation to prepare the implant socket with a working length that is 1-2 mm shorter than the residual bone height as determined by radiographic examination. After preparation, a series of osteotomes of varying diameters will be sequentially utilized to widen the osteotomy and elevate the Schneiderian membrane by vertical tapping to create a "greenstick" fracture. The Valsalva maneuver (nasal blowing test) will be performed to determine the integrity of the Schneiderian membrane. During the osteotomy, the graft material will be injected and slowly placed into the elevated space using osteotomes until the desired depth is reached. Implant placement and suturing will conclude the procedure.

Study summary

The sinus lift technique through alveolar crest Osseodensification is conservative, minimally invasive, and minimally traumatic, utilizing hydropneumatic counterclockwise rotating instruments to lift the maxillary sinus floor without touching the Schneiderian membrane, thereby minimizing the risk of perforation. In contrast, the internal sinus lift technique utilizing osteotomes to raise the Schneiderian membrane eliminated hammering, making the technique more patient-friendly, with the placement of a graft biomaterial around the implant. The challenge in this technique was the availability of \> 5mm residual bone height preventing membrane perforation and low primary implant stability. Consequently, the investigator aims to compare the efficacy and clinical outcomes of Osseodensification and Osteotome internal sinus lifting after delayed implant placement by assessing bone gain and bone density around implants radiographically, the primary stability of the implants clinically, and patient satisfaction.

Eligibility

Sex
ALL
Min age
18 Years
Max age
40 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 1\. Patient partially edentulous with maxillary posterior edentulous ridge after extraction of more than 4 months. 2\. Both sexes will be selected males and females. 3\. Adult patients aged between 18 and 40 years of age. 4\. Good general health (American Society of Anesthesiology Physical Status Ⅰ-Ⅱ). 5\. Initial residual alveolar ridge height ranging between 4 to 6 mm according to preoperative CBCT. 6\. No previous surgery or radiation treatment on the maxillary sinus. Exclusion Criteria: * 1\. Smokers. 2\. Pregnant or lactating females. 3\. Psychiatric disorders. 4\. Uncontrolled systemic disease. 5\. Hematologic diseases and coagulation disorders. 6\. Chemotherapy or radiotherapy of the head and neck area, and immunocompromised status. 7\. Medical conditions affecting bone metabolism and ongoing treatment with bisphosphonates drugs or systemic steroids. 8\. Presence of acute or chronic sinus pathoses or sinus membrane perforation.

Primary outcome measure(s)

  • Radiographic Assessment of Change in the Vertical Bone Height (Bone Gain). — Pre-operative and Immediately post-operative.
    The outcome will be obtained by the aid of Computed Cone Beam Tomography, assessing the amount of change from the pre-operative to the post-operative vertical bone height in millimeters.
  • Radiographic Assessment of Change in the Bone Density. — Pre-operative and Immediately post-operative.
    The outcome will be obtained by the aid of Computed Cone Beam Tomography assessing the amount of change from the pre-operative to the post-operative bone density values in Hounsfield unit.

Trial sites (2)

FacilityCityRegionStatus
Faculty of Dentistry- Assiut University Asyut Egypt Recruiting
Faculty of Dentistry- Ain Shams University Cairo Egypt Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05495490 on ClinicalTrials.gov ↗ ← All trials in Egypt