ClinicalTrials.gg
RecruitingNCT07424742G-TSFEUpdated Jun 2, 2026

Graftless TSFE Via Self-tapping Implants

An interventional study of Graftless Transcrestal Sinus Membrane Elevation with Simultaneous Implant Placement in Edentulous Posterior Maxilla, Maxillary Sinus Pneumatization and Alveolar Bone Atrophy, sponsored by Sana'a University. Recruiting at 1 site in Yemen. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-02.

Sponsored by Sana'a University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2026, 3 months ago, but the record still lists the study as recruiting.
  • Registered 1 year 5 months after the study started (first participant enrolled Sep 2024, registered Feb 2026).
  • Started Sep 2024; still recruiting 2 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Edentulous Posterior Maxilla
  • Maxillary Sinus Pneumatization
  • Alveolar Bone Atrophy

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Keywords

  • Transcrestal Sinus Lift
  • Graftless Sinus Elevation
  • Schneiderian Membrane
  • Dental Implant
  • Posterior Maxilla
  • Osseointegration
  • CBCT
03

In context

Alveolar Bone Loss

318 studies on the registry are indexed under Alveolar Bone Loss; 79 are open to participants now.

This study's planned enrollment of 20 is below the median of 25 across 269 interventional studies indexed under Alveolar Bone Loss.

Browse Alveolar Bone Loss studies →

Lead sponsor

Sana'a University is the lead sponsor of 27 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Adults aged 18-80 years.
  2. Patients with edentulous posterior maxilla.
  3. Residual bone height approximately 4-6 mm.
  4. Indicated for transcrestal sinus membrane elevation.
  5. Good general health ().
  6. Ability to provide written .
  7. Willingness to attend follow-up visits.

Exclusion criteria

Exclusion Criteria:

  1. Severe systemic diseases ( or above).
  2. Uncontrolled diabetes mellitus.
  3. Active sinus pathology.
  4. History of radiotherapy in the head and neck region.
  5. Heavy smokers (>10 cigarettes/day).
  6. Pregnancy or lactation.
  7. Untreated periodontal disease.

7. Poor oral hygiene.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Graftless Transcrestal Sinus Lift with Simultaneous Implant Placement

    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.

    Procedure: Graftless Transcrestal Sinus Membrane Elevation with Simultaneous Implant Placement

Interventions

  • ProcedureGraftless Transcrestal Sinus Membrane Elevation with Simultaneous Implant Placement

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months after surgery

07

Study locations

1 of 1 sites recruiting
  • Department of Oral and Maxillofacial Surgery, Sana'a University
    Sanaa, Sanaa Governorate 00000, Yemen
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Analytic code

Time frame: De-identified individual participant data (IPD) and supporting documents will be made available beginning 6 months after publication of the primary results and will remain available for up to 5 years.

Access criteria: Access will be granted to qualified researchers who provide a methodologically sound research proposal. Requests will be reviewed by the principal investigator. Data will be shared after approval and signing of a data use agreement to ensure participant confidentiality.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2024 (actual). Primary completion is estimated for Aug 2026, 22 months after the start.

Of 167 non-industry interventional studies with no phase under Alveolar Bone Loss, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 30. This study's planned 22 months is above that.

Counting every sponsor, half of 167 studies reached it within 18 months; a quarter within 11 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 14, 2026
First posted
Feb 20, 2026
StartActual
Sep 9, 2024
Primary completionEst.
Aug 8, 2026
CompletionEst.
Sep 9, 2026
Last update
Jun 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07424742
Lead sponsor
Sana'a University
Responsible party
Samar Ahmed Ali Al-Ansi (Postgraduate Researcher, Faculty of Dentistry, Sana'a University, Sana'a University) — Principal investigator
First posted
Feb 20, 2026
Start date
Sep 9, 2024
Primary completion
Aug 8, 2026 (estimated)
Completion
Sep 9, 2026 (estimated)
Last update
Jun 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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