Graftless TSFE Via Self-tapping Implants (G-TSFE)

May 30, 2026 updated by: Samar Ahmed Ali Al-Ansi, Sana'a University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Yemen
    • Sanaa Governorate
      • Sanaa, Sanaa Governorate, Yemen, 00000
        • Recruiting
        • Department of Oral and Maxillofacial Surgery, Sana'a University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 (ASA I or II).
  6. Ability to provide written informed consent.
  7. Willingness to attend follow-up visits.

Exclusion Criteria:

  1. Severe systemic diseases (ASA III 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sana'a University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2024

Primary Completion (Estimated)

August 8, 2026

Study Completion (Estimated)

September 9, 2026

Study Registration Dates

First Submitted

February 14, 2026

First Submitted That Met QC Criteria

February 14, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 30, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMFS:12/06/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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