Study title: Comparison of clinical, radiographic, histological, and patient-reported outcome/ experience measures of endoscopically-monitored graftless transcrestal sinus floor (TSFE) elevation with 1-stage simultaneous multiple implant placement using osseodensification versus osteotomes in subsinus bone height of 4-5 mm: An 18-month double-arm randomized controlled trial. Principal investigator: Georgina El-Ghoul, DDS, MSc. Contact: georginaelghoule@gmail.com Institution: Department of Periodontology, Faculty of Dental Medicine, Saint Joseph University of Beirut, Lebanon. 1. Introduction You are being asked to participate in a research study comparing 2 different procedures used in graftless TSFE with simultaneous implant placement in areas where there is limited amount of bone (4-5 mm) over a period of 18 months. TSFE is used to elevate the sinus membrane to allow new bone formation under the elevated membrane. TSFE can be achieved using either mechanical tools (osteotome) or specially designed burs (osseodensification burs). Currently, the 2 procedures are used by clinicians worldwide with excellent short- and long-term outcomes. You fit the selection criteria of patients enrolled in the study because you have partial posterior edentulism with more than one tooth missing and limited bone height below the maxillary sinus, a condition that is typically treated with graftless TSFE and simultaneous implant placement. 2. Purpose of the study The goal is to evaluate which technique, osseodensification or osteotomes, provides better bone healing, implant stability, and a more comfortable experience for the patient. TSFE procedures are blindly performed without direct intra-operative visualization of the sinus membrane. Since intra-operative sinus membrane perforation has been suggested to increase the risk of implant failure, the incorporation of endoscopy in TSFE provides a real-time magnified intra-operative view of the sinus membrane throughout the entire TSFE and implant placement, thus allowing a precise and controlled sinus elevation with minimal or no risks of perforation. 3. Procedures involved in this study If you agree to participate, you will be randomly assigned to one of 2 groups: * test group (osseodensification): sinus floor elevation using rotating burs; or * control group (osteotomes): sinus floor elevation using manual surgical instruments. The following will occur for all participants: * CBCT: pre-surgically, immediately at the end of the surgery, 6 and 12 months following delivery of the definitive prosthesis; * surgery: sinus floor elevation with simultaneous multiple implant placement using either osseodensification or osteotomes under local anesthesia; * endoscopic monitoring: TSFE is conventionally performed blindly without direct visualization of the delicate sinus membrane during the procedure. In this study, we will use a small specialized camera- an endoscope- through a very small bony hole located either within the surgical area or at a close separate location. This will allow us to enhance the procedure by visualizing the sinus interior and sinus membrane in real-time on a screen during the entire surgery. This monitoring technology will ensure that the sinus membrane stays intact while we create space for your implants, and therefore reduce the risk of implant failure; * biopsy (histomorphometric analysis): when possible, a small bone or implant-bone core that include osseointegrated non-strategic implants (prepared with the OD and OT approaches) along with a thin layer of surrounding bone will be retrieved and analyzed. The non-strategic implant is placed only for research purposes during the same appointment as your planned implants. It is not intended to support your planned bridge. The retrieval of this non-strategic implant involves a second minor and fast flapless procedure 6 months following the main surgery. This test implant will be sent to a laboratory to examine the bone-to-implant connection under a microscope. This will allow us to better understand how quickly and strongly the bone heals around implants using TSFE; and * follow-up (18 months): regular visits for evaluation and tooth cleaning at intervals of 3 months following delivery of the definitive prosthesis. You will be asked to complete surveys about your post-operative course and your overall treatment experience. 4. Risks involved Beyond the normal post-operative course which include potential discomfort, swelling, and hematoma, infrequent complications may occur such as post-surgical infection, bleeding, vertigo, and muscle spasms related to mouth opening. The CBCT radiation dose used each time is roughly equivalent to 6-9 months of natural background radiation (rocks, sun, air, flights). 5. Expected benefits to the patient Sinus augmentation will help generate bone around the implants that replace your missing teeth. Your participation will help improve future treatments for other
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
44
Osseodensification(OD) technique: Osseodensification-mediated transcrestal sinus floor elevation with burs in a counter-clockwise mode designed for bone compaction Osteotome Technique (OT): Osteotome-mediated transcrestal sinus floor elevation with sequential drills and tapered osteotomes
Transcrestal sinus floor elevation performed using the modified Summers osteotome technique with sequential drilling and tapered osteotomes according to residual bone height and bone quality, followed by controlled sinus membrane elevation and immediate implant placement
Saint Joseph University
Beirut, Lebanon
Insertion torque value
Insertion torque value(ITV) will be recorded during the last ¼ turn before the desired insertion depth is reached using a calibrated manual torque wrench (0-90 Ncm) (ZimVie Americas). Platform-switched healing abutments will be hand-tightened on top of the implants when the ITV achieved is \> 20 Ncm. In cases where implant stability is \<20 Ncm, the implant(s) will be fully submerged (2-stage approach) but not excluded from the study.
Time frame: ITV will be evaluated at implant placement(Day0)
ITV will be recorded during the last ¼ turn before the desired insertion depth is reached using a calibrated manual torque wrench (0-90 Ncm) (ZimVie Americas).
recorded during the last ¼ turn before the desired insertion depth is reached using a calibrated manual torque wrench (0-90 Ncm) (ZimVie Americas).
Time frame: recorded during the last ¼ turn before the desired insertion depth is reached at implant placement (Day 0)
Implant survival
implant failure will be defined as any implant mobility, infection and/or progressive peri-implant bone loss necessitating implant removal and/or mechanical complications rendering the implant unusable.
Time frame: Stability of individual implants (without the fixed prosthesis) will be assessed at delivery of the definitive fixed prosthesis at 6 months, 12months and 18 months following implant placement , and when problems are clinically/ radiographically not
Incidence, size and timing of occurrence of Sinus Membrane Perforation (SMPs)
SMP will be assessed throughout the various phases of osteotomy site preparation prior to implant placement using 3 different clinical approaches: the Valsalva maneuver: direct visualization with a Dental microscope, direct visualization with a micro-camera In addition, the endoscope will be used to document sinus membrane status throughout the entire procedure including implant placement. if a perforation occurs its characteristics are recorded according to the classification of Tavelli et al
Time frame: prior to implant placement, throughout the entire procedure including implant placement
Endo sinus bone gain
endo-sinus bone gain beyond implant apex , vertical height of endo-sinus bone, • horizontal bucco-palatal width of endo-sinus bone gain, horizontal mesio-distal width of endo-sinus bone gain ratio of the vertical height to the horizontal bucco-palatal width of endo-sinus bone gain; and • ratio of the vertical height to the horizontal mesio-distal width of endo-sinus bone gain
Time frame: The following 6 outcome measures related to linear endo-sinus bone gain will be recorded at 6 and 18 months following implant placement on bucco-palatal and mesio-distal CBCT views using the framework of Coutant et al.
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