About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
1. Patient partially edentulous with maxillary posterior edentulous ridge after extraction of more than 4 months.
Disqualifiers
1. Smokers.
Trial design
Parallel
Treatments tested in this trial
Osseodensification Internal Sinus Lift
Procedure/SurgeryThe 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
Procedure/SurgeryThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Radiographic Assessment of Change in the Vertical Bone Height (Bone Gain).
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.
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.
Secondary outcomes
Clinical Assessment of Primary Stability of the Implants ( Insertion Torque Value) Measured by a Torque Wrench.
The outcome will be obtained by the aid of a torque wrench and recorded in Newton centimeters. ( low torque (\<30), medium torque (30 \< Insertion Torque \< 50), and high torque (\>50).
Clinical Assessment of Primary Stability of the Implants (Implant Stability Quotient ) Measured by an Osstell® Device.
The outcome will be obtained by the aid of an Osstell device, measured by the Resonance Frequency Analysis and determined by the Implant Stability Quotient ( within a 0-100 scale; 100 being maximum implant stability) .
Patient's Post-Operative Pain Assessment
The outcome will be obtained by the aid of a 100 mm Visual Analogue Scale (0 = minimal to; 100 = maximum)
Patient's Satisfaction Assessment.
The outcome will be obtained by the aid of a health-related quality of life questionnaire designed to assess the patient's perception of recovery concerning pain, oral function, general activity, and other symptoms.
Sponsors and contacts
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