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NCT Number: NCT07424742

Graftless TSFE Via Self-tapping Implants

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Oral and Maxillofacial Surgery, Sana'a University

Sanaa, Sanaa Governorate, 00000, Yemen

Location status: Recruiting

Location contact

Samar A Al-Ansi, BDS

CONTACT

[email protected]

+967775775461

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Poor oral hygiene.

Treatment and study plan

Graftless Transcrestal Sinus Membrane Elevation with Simultaneous Implant Placement

Procedure

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Sana'a University

Other

Registry information

Official study title

Transcrestal Graftless Schneiderian Membrane Elevation by Self-tapping Dental Implant

Acronym: G-TSFE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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