Not Yet RecruitingNot Applicable

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

Lebanon44 participantsStarted 2026-09-30

Plain-language 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. 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

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * \>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 Exclusion criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Insertion torque value

Timeframe: 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).

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

Trial details

NCT IDNCT07719283

SponsorSaint-Joseph University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10

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