Edentulous Posterior MaxillaG-TSFENCT07424742
Graftless TSFE Via Self-tapping Implants
A study testing Graftless Transcrestal Sinus Membrane Elevation with Simultaneous Implant Placement in people with Edentulous Posterior Maxilla and Maxillary Sinus Pneumatization, run by Sana'a University at 1 site in Yemen.
Trial summary
This prospective clinical trial aims to evaluate the efficiency, safety, and reliability of a minimally invasive graftless transcrestal sinus lifting approach with simultaneous dental implant placement in patients with edentulous posterior maxilla and limited residual bone height. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Edentulous Posterior Maxilla, Maxillary Sinus Pneumatization, Alveolar Bone Atrophy
- What is being tested?
- Graftless Transcrestal Sinus Membrane Elevation with Simultaneous Implant Placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteYemen
- Study dates
- 9 Sep 2024to 9 Sep 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-80 years.
- Patients with edentulous posterior maxilla.
- Residual bone height approximately 4-6 mm.
- Indicated for transcrestal sinus membrane elevation.
- Good general health (ASA I or II).
- Ability to provide written informed consent.
- Willingness to attend follow-up visits.
Who cannot join
- Severe systemic diseases (ASA III or above).
- Uncontrolled diabetes mellitus.
- Active sinus pathology.
- History of radiotherapy in the head and neck region.
- Heavy smokers (>10 cigarettes/day).
- Pregnancy or lactation.
- Untreated periodontal disease.
- 7. Poor oral hygiene.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yemen1 site, 1 recruiting
- Recruiting
Department of Oral and Maxillofacial Surgery, Sana'a University
Sanaa, Sanaa Governorate, 00000
Samar A Al-Ansi, BDS, +967775775461, smr.alansi@su.edu.ye
About this study
Official title: Transcrestal Graftless Schneiderian Membrane Elevation by Self-tapping Dental Implant
This prospective clinical trial aims to evaluate the efficiency, safety, and reliability of a minimally invasive graftless transcrestal sinus lifting approach with simultaneous dental implant placement in patients with edentulous posterior maxilla and limited residual bone height.
The study investigates bone formation beneath the Schneiderian membrane, implant stability, osseointegration, and long-term implant survival.
Read the detailed description
This prospective clinical study evaluates a minimally invasive graftless sinus lifting technique using a transcrestal approach with simultaneous implant placement in the posterior maxilla.
The procedure involves tenting the Schneiderian membrane without the use of grafting material, relying on blood clot formation and natural bone regeneration beneath the elevated membrane.
Radiographic and clinical evaluations will be performed preoperatively, immediately postoperatively, and at 6 months to assess bone formation, implant stability, and osseointegration.
- Being tested
- Graftless Transcrestal Sinus Membrane Elevation with Simultaneous Implant Placement
- Keywords
- Transcrestal Sinus Lift, Graftless Sinus Elevation, Schneiderian Membrane, Dental Implant, Posterior Maxilla, Osseointegration, CBCT
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graftless Transcrestal Sinus Membrane Elevation with Simultaneous Implant PlacementProcedure or surgery
A minimally invasive transcrestal approach for sinus membrane elevation without graft material, followed by simultaneous placement of a 10 mm length and 4-4.5 mm diameter dental implant in the posterior maxilla with residual bone height of approximately 5 mm.
| Study group | Role | What they receive |
|---|---|---|
| Graftless Transcrestal Sinus Lift with Simultaneous Implant Placement | Experimental | Participants with edentulous posterior maxilla and residual bone height of approximately 5 mm will undergo minimally invasive graftless transcrestal sinus membrane elevation followed by simultaneous placement of a 10 mm length and 4-4.5 mm diameter dental implant. Receives: Procedure: Graftless Transcrestal Sinus Membrane Elevation with Simultaneous Implant Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Newly Formed Bone After Graftless Transcrestal Sinus Elevation
Radiographic assessment of the amount of newly formed bone in the elevated sinus space using CBCT.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start9 Sep 2024
- Primary completion8 Aug 2026 (estimated)
- Study completion9 Sep 2026 (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 Edentulous Posterior MaxillaStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective single-arm clinical study in which all enrolled participants undergo transcrestal graftless sinus membrane elevation with simultaneous dental implant placement. Clinical and radiographic evaluations are performed preoperatively, immediately postoperatively, and at 6 months to assess bone formation and implant stability.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sana'a University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Ahmed Ali Al-Ansi, Sana'a University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424742
- Sponsor's protocol ID
- OMFS:12/06/2024
- Acronym
- G-TSFE
- Status last verified
- Feb 2026
- First submitted
- 14 Feb 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results reported in this study will be shared after publication. Data will be available upon reasonable request to the corresponding author. Requests must include a methodologically sound proposal and will require approval by the institutional review board. Data will be shared for academic purposes only.
Publications
Albadani MM, Elayah SA, Al-Wesabi MA, Al-Aroomi OA, Al Qadasy NE, Saleh H. A graftless maxillary sinus lifting approach with simultaneous dental implant placement: a prospective clinical study. BMC Oral Health. 2024 Feb 13;24(1):227. doi: 10.1186/s12903-024-03949-9.
PubMed 38350895
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcrestal Graftless Schneiderian Membrane Elevation by Self-tapping Dental Implant
- ClinicalTrials.gov ID
- NCT07424742
- Acronym / sponsor ID
- G-TSFE / OMFS:12/06/2024
- Keywords
- Transcrestal Sinus Lift, Graftless Sinus Elevation, Schneiderian Membrane, Dental Implant, Posterior Maxilla, Osseointegration, CBCT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sana'a UniversityUniversity, hospital or other
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 8 Aug 2026 (estimated)
- Study completion
- 9 Sep 2026 (estimated)
- First posted
- 20 Feb 2026 (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 clinical trial aims to evaluate the efficiency, safety, and reliability of a minimally invasive graftless transcrestal sinus lifting approach with simultaneous dental implant placement in patients with edentulous posterior maxilla and limited residual bone height.
The study investigates bone formation beneath the Schneiderian membrane, implant stability, osseointegration, and long-term implant survival.
Detailed description
This prospective clinical study evaluates a minimally invasive graftless sinus lifting technique using a transcrestal approach with simultaneous implant placement in the posterior maxilla.
The procedure involves tenting the Schneiderian membrane without the use of grafting material, relying on blood clot formation and natural bone regeneration beneath the elevated membrane.
Radiographic and clinical evaluations will be performed preoperatively, immediately postoperatively, and at 6 months to assess bone formation, implant stability, and osseointegration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective single-arm clinical study in which all enrolled participants undergo transcrestal graftless sinus membrane elevation with simultaneous dental implant placement. Clinical and radiographic evaluations are performed preoperatively, immediately postoperatively, and at 6 months to assess bone formation and implant stability.
| Arm | Type | Receives |
|---|---|---|
| Graftless Transcrestal Sinus Lift with Simultaneous Implant Placement | Experimental | Procedure: Graftless Transcrestal Sinus Membrane Elevation with Simultaneous Implant PlacementParticipants with edentulous posterior maxilla and residual bone height of approximately 5 mm will undergo minimally invasive graftless transcrestal sinus membrane elevation followed by simultaneous placement of a 10 mm length and 4-4.5 mm diameter dental implant. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 18-80 years.
- Patients with edentulous posterior maxilla.
- Residual bone height approximately 4-6 mm.
- Indicated for transcrestal sinus membrane elevation.
- Good general health (ASA I or II).
Key exclusion criteria (8 listed)
- Severe systemic diseases (ASA III or above).
- Uncontrolled diabetes mellitus.
- Active sinus pathology.
- History of radiotherapy in the head and neck region.
- Heavy smokers (>10 cigarettes/day).
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 |
|---|---|---|
| Graftless Transcrestal Sinus Membrane Elevation with Simultaneous Implant PlacementA minimally invasive transcrestal approach for sinus membrane elevation without graft material, followed by simultaneous placement of a 10 mm length and 4-4.5 mm diameter dental implant in the posterior maxilla with residual bone height of approximately 5 mm. | Procedure or surgery | Graftless Transcrestal Sinus Lift with Simultaneous Implant Placement |
Primary outcome
Amount of Newly Formed Bone After Graftless Transcrestal Sinus Elevation
Time frame: 6 months after surgery
Radiographic assessment of the amount of newly formed bone in the elevated sinus space using CBCT.
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 2 Jun 2026.
- Results publication: PubMed 38350895Albadani MM, Elayah SA, Al-Wesabi MA, Al-Aroomi OA, Al Qadasy NE, Saleh H. A graftless maxillary sinus lifting approach with simultaneous dental implant placement: a prospective clinical study. BMC Oral Health. 2024 Feb 13;24(1):227. doi: 10.1186/s12903-024-03949-9.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the results reported in this study will be shared after publication. Data will be available upon reasonable request to the corresponding author. Requests must include a methodologically sound proposal and will require approval by the institutional review board. Data will be shared for academic purposes only.
Related trials for Edentulous Posterior Maxilla
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Clinical and Radiographic Comparison of Two Implant-Abutment Connections
Dental Implant, Edentulous Alveolar Ridge
Recruiting
Clinical and Radiographic Evaluation of UV-Treated Dental Implants With or Without Melatonin in the Upper Posterior Jaw
Jaw, Edentulous, Partially, Bone Resorption
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.
Department of Oral and Maxillofacial Surgery, Sana'a University
Sanaa, Yemen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graftless Transcrestal Sinus Membrane Elevation with Simultaneous Implant Placement in people with Edentulous Posterior Maxilla and Maxillary Sinus Pneumatization, run by Sana'a University at 1 site in Yemen.
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 7 inclusion and 8 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 2 Jun 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 Yemen. 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?
Amount of Newly Formed Bone After Graftless Transcrestal Sinus Elevation (time frame: 6 months after 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 NCT07424742, 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 2 Jun 2026.