Sinus Lift Surgery ComplicationsPMSLNCT07017413
Predictors For Transosseous Maxillary Sinus Lift Complications
A study testing Transosseous Maxillary Sinus Lift using Osseodensification in people with Sinus Lift Surgery Complications and Maxillary Sinus Elevation, run by University of Baghdad at 2 sites in Iraq.
Trial summary
This prospective cohort study aims to identify clinical and anatomical predictors for complications following transosseous maxillary sinus lift procedures using the Versah (Densah burs) technique. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sinus Lift Surgery Complications, Maxillary Sinus Elevation
- What is being tested?
- Transosseous Maxillary Sinus Lift using Osseodensification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesIraq
- Study dates
- 30 Nov 2024to 12 Dec 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1- Patients requiring dental implants in the posterior maxilla with a residual bone height of < 6 mm.
- 2- Good general health and absence of systemic conditions affecting bone healing (e.g., uncontrolled diabetes, osteoporosis).
- 3- No history of chronic sinusitis or other significant sinus pathologies
Who cannot join
- 1- Severe periodontal disease. 2- Residual bone height > 6 mm. 3- History of previous sinus lift procedures or other maxillofacial surgeries. 4- Smokers.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq2 sites, 2 recruiting
- Recruiting
College of Dentistry , University of Baghdad
Baghdad, Bab Almodaum, 1214
Ahmed Fadhil, BDS. FIBMS, +9647811896313
- Recruiting
Planto clinic
Baghdad, Mansour, 1456
Mustafa Al-Jamal, BDS. MSc, +9647722333503
About this study
Official title: Predictors For Transosseous Maxillary Sinus Lift Complications: A Prospective Cohort Study
This prospective cohort study aims to identify clinical and anatomical predictors for complications following transosseous maxillary sinus lift procedures using the Versah (Densah burs) technique. The study focuses on patients undergoing transcrestal sinus floor elevation without a lateral window, with or without simultaneous dental implant placement. Variables such as residual bone height, sinus membrane thickness, bone density, and patient-related factors are being evaluated. The objective is to enhance risk stratification and optimize treatment planning for transosseous sinus augmentation.
Read the detailed description
This prospective cohort study investigates potential predictors of complications associated with transosseous sinus lift procedures utilizing the Versah Densah burs technique. Unlike the traditional lateral approach, this method enables internal sinus floor elevation through a crestal access, minimizing invasiveness while allowing for controlled vertical augmentation.
The study population includes partially edentulous patients in need of vertical ridge augmentation in the posterior maxilla. The following parameters are evaluated as possible predictors of intraoperative and postoperative complications:
- Residual Bone Height (RBH): Measured from the alveolar crest to the sinus floor.
- Maxillary Sinus Ostium (MSO) Patency: Assessed radiographically to determine if ostial obstruction contributes to sinus-related events.
- Schneiderian Membrane Thickness: Measured preoperatively via CBCT, as thicker or thinner membranes may influence perforation risk.
- Surgical Site Location: Categorized based on the involved maxillary posterior region (e.g., premolar vs. molar).
- Amount of Vertical Lifting: The total height gained through osteotome-mediated or Densah bur-mediated elevation is recorded.
Primary outcome measures include intraoperative membrane perforation, postoperative sinusitis, implant failure, and the need for revision surgery. The study aims to establish reliable preoperative indicators to stratify complication risk, facilitate clinical decision-making, and improve patient outcomes in transosseous sinus elevation procedures.
- Being tested
- Transosseous Maxillary Sinus Lift using Osseodensification
- Keywords
- Transosseous sinus lift, Versah sinus lift, Schneiderian membrane perforation, Residual bone height RBH, Maxillary sinus, Densah bur, Implant surgery complications, Risk predictors sinus elevation, MSSM, decision tree
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transosseous Maxillary Sinus Lift using OsseodensificationProcedure or surgery
A surgical procedure utilizing the Versah® osseodensification technique for transcrestal sinus floor elevation. The approach involves the use of specialized Densah® burs to prepare the osteotomy and elevate the sinus membrane through a transosseous (crestal) access, avoiding the lateral window technique. No grafting materials will be used in this procedure.
| Study group | Role | What they receive |
|---|---|---|
| Transosseous Sinus Lift Group | Experimental | Patients will undergo transcrestal maxillary sinus lift using the Versah® osseodensification technique. This arm aims to evaluate the predictors of surgical complications, including residual bone height (RBH), maxillary sinus ostium (MSO) status, Schneiderian membrane thickness, surgical site (tooth location), and amount of vertical lifting required. Receives: Procedure: Transosseous Maxillary Sinus Lift using Osseodensification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite incidence of maxillary sinus membrane perforation and graft displacement, and identification of associated predictors
This primary outcome assesses the intraoperative occurrence of Schneiderian membrane perforation and graft displacement during transosseous maxillary sinus lift. It also involves the identification of anatomical and surgical predictors, including residual bone height (RBH), maxillary sinus ostium patency, sinus membrane thickness, surgical site, and the amount of vertical lift performed.
Measured: Intraoperative phase to 1 month post-surgery
Secondary outcomes (1)
Postoperative Infection Rate
Incidence of infection or sinusitis following the transcrestal sinus lift procedure, confirmed clinically or radiographically.
Measured: Within 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start30 Nov 2024
- Primary completion30 Oct 2025 (estimated)
- Study completion12 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sinus Lift Surgery ComplicationsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled patients will undergo transosseous maxillary sinus lift using the Versah Densah bur technique. Outcomes and predictors of intraoperative and postoperative complications will be assessed within this cohort.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Faisal Al-Jamal, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017413
- Sponsor's protocol ID
- 1045125
- Acronym
- PMSL
- Status last verified
- Jun 2025
- First submitted
- 25 May 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to ethical considerations and to maintain patient confidentiality. Data will only be used for the purposes of this study and will not be made publicly available.
Publications
Huwais S, Meyer EG. A Novel Osseous Densification Approach in Implant Osteotomy Preparation to Increase Biomechanical Primary Stability, Bone Mineral Density, and Bone-to-Implant Contact. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):27-36. doi: 10.11607/jomi.4817. Epub 2016 Oct 14.
PubMed 27741329
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors For Transosseous Maxillary Sinus Lift Complications: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07017413
- Acronym / sponsor ID
- PMSL / 1045125
- Keywords
- Transosseous sinus lift, Versah sinus lift, Schneiderian membrane perforation, Residual bone height RBH, Maxillary sinus, Densah bur, Implant surgery complications, Risk predictors sinus elevation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 30 Nov 2024 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 12 Dec 2025 (estimated)
- First posted
- 12 Jun 2025 (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.
This prospective cohort study aims to identify clinical and anatomical predictors for complications following transosseous maxillary sinus lift procedures using the Versah (Densah burs) technique. The study focuses on patients undergoing transcrestal sinus floor elevation without a lateral window, with or without simultaneous dental implant placement. Variables such as residual bone height, sinus membrane thickness, bone density, and patient-related factors are being evaluated. The objective is to enhance risk stratification and optimize treatment planning for transosseous sinus augmentation.
Detailed description
This prospective cohort study investigates potential predictors of complications associated with transosseous sinus lift procedures utilizing the Versah Densah burs technique. Unlike the traditional lateral approach, this method enables internal sinus floor elevation through a crestal access, minimizing invasiveness while allowing for controlled vertical augmentation.
The study population includes partially edentulous patients in need of vertical ridge augmentation in the posterior maxilla. The following parameters are evaluated as possible predictors of intraoperative and postoperative complications:
- Residual Bone Height (RBH): Measured from the alveolar crest to the sinus floor.
- Maxillary Sinus Ostium (MSO) Patency: Assessed radiographically to determine if ostial obstruction contributes to sinus-related events.
- Schneiderian Membrane Thickness: Measured preoperatively via CBCT, as thicker or thinner membranes may influence perforation risk.
- Surgical Site Location: Categorized based on the involved maxillary posterior region (e.g., premolar vs. molar).
- Amount of Vertical Lifting: The total height gained through osteotome-mediated or Densah bur-mediated elevation is recorded.
Primary outcome measures include intraoperative membrane perforation, postoperative sinusitis, implant failure, and the need for revision surgery. The study aims to establish reliable preoperative indicators to stratify complication risk, facilitate clinical decision-making, and improve patient outcomes in transosseous sinus elevation procedures.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled patients will undergo transosseous maxillary sinus lift using the Versah Densah bur technique. Outcomes and predictors of intraoperative and postoperative complications will be assessed within this cohort.
| Arm | Type | Receives |
|---|---|---|
| Transosseous Sinus Lift Group | Experimental | Procedure: Transosseous Maxillary Sinus Lift using OsseodensificationPatients will undergo transcrestal maxillary sinus lift using the Versah® osseodensification technique. This arm aims to evaluate the predictors of surgical complications, including residual bone height (RBH), maxillary sinus ostium (MSO) status, Schneiderian membrane thickness, surgical site (tooth location), and amount of vertical lifting required. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1- Patients requiring dental implants in the posterior maxilla with a residual bone height of < 6 mm.
- 2- Good general health and absence of systemic conditions affecting bone healing (e.g., uncontrolled diabetes, osteoporosis).
- 3- No history of chronic sinusitis or other significant sinus pathologies
Key exclusion criteria (1 listed)
- 1- Severe periodontal disease. 2- Residual bone height > 6 mm. 3- History of previous sinus lift procedures or other maxillofacial surgeries. 4- Smokers.
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 |
|---|---|---|
| Transosseous Maxillary Sinus Lift using OsseodensificationA surgical procedure utilizing the Versah® osseodensification technique for transcrestal sinus floor elevation. The approach involves the use of specialized Densah® burs to prepare the osteotomy and elevate the sinus membrane through a transosseous (crestal) access, avoiding the lateral window technique. No grafting materials will be used in this procedure. | Procedure or surgery | Transosseous Sinus Lift Group |
Primary outcome
Composite incidence of maxillary sinus membrane perforation and graft displacement, and identification of associated predictors
Time frame: Intraoperative phase to 1 month post-surgery
This primary outcome assesses the intraoperative occurrence of Schneiderian membrane perforation and graft displacement during transosseous maxillary sinus lift. It also involves the identification of anatomical and surgical predictors, including residual bone height (RBH), maxillary sinus ostium patency, sinus membrane thickness, surgical site, and the amount of vertical lift performed.
1 secondary outcome
Postoperative Infection Rate
Time frame: Within 3 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Results publication: PubMed 27741329Huwais S, Meyer EG. A Novel Osseous Densification Approach in Implant Osteotomy Preparation to Increase Biomechanical Primary Stability, Bone Mineral Density, and Bone-to-Implant Contact. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):27-36. doi: 10.11607/jomi.4817. Epub 2016 Oct 14.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to ethical considerations and to maintain patient confidentiality. Data will only be used for the purposes of this study and will not be made publicly available.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transosseous Maxillary Sinus Lift using Osseodensification in people with Sinus Lift Surgery Complications and Maxillary Sinus Elevation, run by University of Baghdad at 2 sites in Iraq.
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 3 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: looking for participants now, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iraq. 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?
Contact Mustafa Al-Jamal, BDS, MSc, PhD (+9647704681045, dr.mustafa.faisal9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite incidence of maxillary sinus membrane perforation and graft displacement, and identification of associated predictors (time frame: Intraoperative phase to 1 month post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07017413, which also lists 1 linked publication.
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 Jun 2025.