An interventional study of Transcrestal sinus floor elevation using osseodensification technique and Osteotome-mediated sinus elevation in Osseodensification Drilling Technique, sponsored by Saint-Joseph University. Not yet recruiting at 1 site in Lebanon. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Saint-Joseph University · Not applicable, Interventional, and Health services research
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.
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.
Procedures involved in this study
If you agree to participate, you will be randomly assigned to one of 2 groups:
The following will occur for all participants:
You will be asked to complete surveys about your post-operative course and your overall treatment experience.
Saint-Joseph University is the lead sponsor of 71 studies on the registry; 11 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intervention protocol arm 1 experimental group: Osseodensification-mediated transcrestal sinus floor elevation (OD-TSFE) where implant recipient sites will be prepared using Densah® burs according to Versah® Lift Protocol II. Osteotomies will preserve at least 1.5 mm of buccal and palatal bone around the implant. Implant length will be selected to achieve approximately 3 mm of apical protrusion into the sinus cavity. Immediate implant placement will then be performed.
Procedure: Transcrestal sinus floor elevation using osseodensification technique
the intervention administered for Osteotome-mediated transcrestal sinus floor elevation (OT-TSFE): Implant recipient sites will be prepared using the modified Summers transcrestal osteotome technique with sequential drills and tapered osteotomes according to residual bone height and bone quality. Gentle manual malleting will be used to minimize patient discomfort while limiting sinus membrane elevation to 3 mm. Immediate implant placement will then be performed
Procedure: Osteotome-mediated sinus elevation
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
Also known as: Osseodensification technique
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
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.
Plan to share: No
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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