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

NCT07719283 | Not Yet Recruiting

• 1 other identifier: CER -2026-314
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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 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.

• 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.
• 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).
• 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

Conditions

Osseodensification Drilling Technique

Keywords

Transcrestal sinus floor augmentation; Endoscopy; Dental implants; Sinus membrane perforation; Implant survival

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

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

Secondary Outcomes (3)

• Implant survival

  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)

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

• Endo sinus bone gain

  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.

Study Arms (2)

Osseodensification (OD) Group using densah burs for sinus elevation with immediate implant placement

EXPERIMENTAL

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

Osteotome Technique (OT) group using the modified Summers osteotome technique with implant placement

ACTIVE COMPARATOR

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

Interventions

Osteotome-mediated sinus elevation PROCEDURE

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

Osteotome Technique (OT) group using the modified Summers osteotome technique with implant placement

Transcrestal sinus floor elevation using osseodensification technique PROCEDURE

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

Osseodensification (OD) Group using densah burs for sinus elevation with immediate implant placement

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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%
• 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

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Saint Joseph University

Beirut, Lebanon

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 22, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): September 1, 2029
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)