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Osseodensification Drilling TechniqueOD - OT - RCTNCT07719283

Clinical, Radiographic, Histological, and Patient-reported/ Experience Outcome Measures of Endoscopically-monitored Graftless Transcrestal Sinus Floor Elevation With Simultaneous Multiple Implant Placement Using Osseodensification(OD) Versus Osteotomes (OT) in Subsinus Bone Height of 4-5 mm: An RCT

A study testing Transcrestal sinus floor elevation using osseodensification technique and Osteotome-mediated sinus elevation in people with Osseodensification Drilling Technique, run by Saint-Joseph University at 1 site in Lebanon.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Osseodensification Drilling Technique
What is being tested?
Transcrestal sinus floor elevation using osseodensification technique and Osteotome-mediated sinus elevation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteLebanon
Study dates
30 Sep 2026to Sep 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • >18 years old
  • Ability and willingness to comply with the study protocol and scheduling
  • Unilateral or bilateral absence of 2-3 consecutive teeth posterior to maxillary the 1st premolar (excluding 3rd molars)
  • Missing teeth extracted or lost > 6months prior to surgery
  • Subsinus residual bone height 4-5 mm
  • Alveolar ridge bucco-palatal width allowing placement of implants with at least 3.7-mm diameter leaving >1.5 mm at the buccal and palatal aspects of the implants
  • Narrow-medium sinus cavities with bucco-palatal width ≤ 15 mm at the 10-mm level including the residual alveolar crest
  • Sinus membrane thickness < 2 mm

Who cannot join

  • Smoking > 10 cigarettes/day
  • Absolute contraindications to implant therapy
  • Pregnancy or lactation
  • Systemic conditions/ medications affecting bone healing
  • Ongoing or history of head and neck irradiation therapy
  • Uncontrolled diabetes with HbA1c > 7%
Show all 14Show fewer
  • Alcohol or drug abuse
  • Ongoing or history of benign paroxysmal positional vertigo
  • Severe parafunctional habits (clenching and bruxism)
  • Maxillary sinus infection or pathology
  • Previous bone augmentation at the planned implant sites
  • Osseous lesions or infections at the planned implant sites
  • Sinus bony septa in line with the planned implant sites
  • Untreated periodontal disease

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lebanon1 site
  • Saint Joseph University

    Beirut

    Georgina El-Ghoul, DDS-Master in Periodontology, 961+ 3702448, georginaelghoule@gmail.com

    Zeina Majzoub, DDS-PhD in periodontology, 39 333 426 2418, zeina.majzoub1@usj.edu.lb

Other trials in Lebanon

About this study

Official title: Clinical, Radiographic, Histological, and Patient-reported/ Experience Outcome Measures of Endoscopically-monitored Graftless Transcrestal Sinus Floor Elevation With Simultaneous Multiple Implant Placement Using Osseodensification Versus Osteotomes in Subsinus Bone Height of 4-5 mm: A Randomized Controlled Trial

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.

Read more
  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.
  1. 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).
  2. 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
Being tested
Transcrestal sinus floor elevation using osseodensification technique, Osteotome-mediated sinus elevation
Keywords
Transcrestal sinus floor augmentation, Endoscopy, Dental implants, Sinus membrane perforation, Implant survival

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcrestal sinus floor elevation using osseodensification techniqueProcedure or surgery

    Also called Osseodensification technique

    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

  • Osteotome-mediated sinus elevationProcedure or surgery

    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

Study groups in NCT07719283
Study groupRoleWhat they receive
Osseodensification (OD) Group using densah burs for sinus elevation with immediate implant placementExperimentalIntervention 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.
Receives: Procedure: Transcrestal sinus floor elevation using osseodensification technique
Osteotome Technique (OT) group using the modified Summers osteotome technique with implant placementActive comparatorthe 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
Receives: Procedure: Osteotome-mediated sinus elevation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: ITV will be evaluated at implant placement(Day0)

  2. 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).

    Measured: recorded during the last ¼ turn before the desired insertion depth is reached at implant placement (Day 0)

Secondary outcomes (3)
  1. 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.

    Measured: 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

  2. 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

    Measured: prior to implant placement, throughout the entire procedure including implant placement

  3. 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

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2026
  2. Study start30 Sep 2026 (estimated)
  3. Primary completionOct 2026 (estimated)
  4. Study completionSep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
Model description
This investigation is designed as a single center double-arm RCT where 2 equal groups of 22 patients will be randomly allocated to OD- or OT-mediated TSFE with immediate placement of 2-3 implants according to a predefined computer-generated block randomization list (block = 6) with 1:1 allocation. Randomization lists will be kept in the password-protected portable computer of the research director, and allocation will be revealed to the surgeon only following completion of flap elevation. Group allocation will be balanced to allow for an equal distribution of type III and type IV bone as assessed pre-operatively on CBCT scans using Lekholm \& Zarb classification . This will be done to exclude the effects of baseline bone quality as a key determinant on implant primary stability. Single and double blinding will not be possible in the present study due to the inherent characteristics of the OD and OT surgeries which are evident to both surgeon and patient.
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07719283
Sponsor's protocol ID
CER -2026-314
Acronym
OD - OT - RCT
Status last verified
Jul 2026
First submitted
13 Jul 2026
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Transcrestal sinus floor elevation using osseodensification technique and Osteotome-mediated sinus elevation in people with Osseodensification Drilling Technique, run by Saint-Joseph University at 1 site in Lebanon.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insertion torque value (time frame: ITV will be evaluated at implant placement(Day0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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