Lateral Sinus LiftNCT05872321
Assessment of the New Lateral Sinus Floor Elevation Technique Using Piezosurgery: A Clinical and Radiographic Prospective Study
An observational study of Lateral Sinus Lift and Per-operation Complications, run by Saint-Joseph University at 1 site in Lebanon.
Trial summary
For patients requiring LSFE, demographic data, including age, sex and smoking habits were collected. Preoperative CBCT images were analyzed for radiographic assessment of risk factors through measurement of sinus mucosa thickness, sinus lateral wall thickness, sinus width, presence of Underwood's septa, and presence… Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Lateral Sinus Lift, Per-operation Complications
- What is being tested?
- Complication
- How many people
- 89 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Jul 2022to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All the patient needing lateral sinus lift procedure prior to implant placement.
Who may be able to join
- Patients who received lateral sinus floor elevation using this new piezosurgery technique.
Who cannot join
- the usual exclsion criteria for external sinus lift procedure
Trial locations and contacts
1 site in 1 country.
About this study
For patients requiring LSFE, demographic data, including age, sex and smoking habits were collected. Preoperative CBCT images were analyzed for radiographic assessment of risk factors through measurement of sinus mucosa thickness, sinus lateral wall thickness, sinus width, presence of Underwood's septa, and presence of the alveolar antral artery. A bone consuming technique using piezosurgery was implemented. This technique involved eroding the buccal bone prior to window outlining followed mucosal elevation using novel ultrasonic curettes. sinus mucosa perforation, hemorrhage, and postoperative infectious complications were documented. The measurement of the studied factors was performed on Newtom VGI viewer software, by two evaluators J.B. and A.M.
- Conditions
- Lateral Sinus Lift, Per-operation Complications
- Being tested
- Complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ComplicationOther
whether or not complications occur
| Study group | Role | What they receive |
|---|---|---|
| Per-operative Complication | Not described Receives: Other: Complication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative complication
We will monitor the prevalence of membrane perforation during external sinus lift procedure
Measured: During surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 Jul 2022
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Sinus LiftStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Makary, Saint-Joseph University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872321
- Sponsor's protocol ID
- FMD-SF86
- Status last verified
- Jun 2023
- First submitted
- 14 May 2023
- Last updated
- 12 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the New Lateral Sinus Floor Elevation Technique Using Piezosurgery: A Clinical and Radiographic Prospective Study
- ClinicalTrials.gov ID
- NCT05872321
- Acronym / sponsor ID
- FMD-SF86
- Conditions
- Lateral Sinus Lift, Per-operation Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For patients requiring LSFE, demographic data, including age, sex and smoking habits were collected. Preoperative CBCT images were analyzed for radiographic assessment of risk factors through measurement of sinus mucosa thickness, sinus lateral wall thickness, sinus width, presence of Underwood's septa, and presence of the alveolar antral artery. A bone consuming technique using piezosurgery was implemented. This technique involved eroding the buccal bone prior to window outlining followed mucosal elevation using novel ultrasonic curettes. sinus mucosa perforation, hemorrhage, and postoperative infectious complications were documented. The measurement of the studied factors was performed on Newtom VGI viewer software, by two evaluators J.B. and A.M.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Per-operative Complication | – | Other: Complication |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All the patient needing lateral sinus lift procedure prior to implant placement.
Key inclusion criteria (1 listed)
- Patients who received lateral sinus floor elevation using this new piezosurgery technique.
Key exclusion criteria (1 listed)
- the usual exclsion criteria for external sinus lift procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complicationwhether or not complications occur | Other | Per-operative Complication |
Primary outcome
Perioperative complication
Time frame: During surgical procedure
We will monitor the prevalence of membrane perforation during external sinus lift procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lateral Sinus Lift and Per-operation Complications, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative complication (time frame: During surgical procedure). 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 12 Feb 2026.