Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID07424742

Transcrestal Graftless Schneiderian Membrane Elevation with Self-tapping Dental Implant Placement

Led by Sana'a University · Updated on 2026-06-02

20

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a minimally invasive graftless sinus lifting technique using a transcrestal approach combined with dental implant placement in patients who have an edentulous posterior maxilla with limited residual bone height. This study aims to assess the efficiency, safety, and reliability of this approach by examining bone formation beneath the Schneiderian membrane, implant stability, osseointegration, and long-term implant survival. The treatment involves elevating the sinus membrane without using any graft material, relying instead on blood clot formation and natural bone regeneration. Participants with about 4 to 6 mm of residual bone height in the posterior maxilla will receive a dental implant measuring 10 mm in length and 4 to 4.5 mm in diameter during the procedure. This implant placement occurs simultaneously with the sinus membrane elevation. Participants will undergo radiographic and clinical evaluations before surgery, immediately after the procedure, and six months later to monitor bone formation and implant stability. The primary outcome measured is the amount of newly formed bone six months after surgery. Participants are expected to attend follow-up visits as part of the study's monitoring process, which extends through the six-month postoperative period.

CONDITIONS

Brief Title

Graftless TSFE Via Self-tapping Implants

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 80 years
  • Patients with edentulous posterior maxilla
  • Residual bone height approximately 4 to 6 millimeters
  • 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
Not Eligible

You will not qualify if you...

  • Severe systemic diseases (ASA III or above)
  • Uncontrolled diabetes mellitus
  • Active sinus pathology
  • History of radiotherapy in the head and neck region
  • Heavy smokers (more than 10 cigarettes per day)
  • Pregnancy or lactation
  • Untreated periodontal disease
  • Poor oral hygiene

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 day

Participants undergo a minimally invasive graftless transcrestal sinus membrane elevation followed by simultaneous placement of a dental implant in the posterior maxilla.

1 procedure visit (in-person)

Post-operative Follow-up

Duration - 6 months

Participants return for radiographic and clinical evaluations to assess bone formation, implant stability, and osseointegration.

2 visits (immediately post-operative and 6 months post-operative, in-person)

Trial Site Locations

Total: 1 location

1

Department of Oral and Maxillofacial Surgery, Sana'a University

Sanaa, Sanaa Governorate, Yemen, 00000

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

A graftless maxillary sinus lifting approach with simultaneous dental implant placement: a prospective clinical study.

Mohammed M Albadani, Sadam Ahmed Elayah, Mohammed Ali Al-Wesabi...

https://pubmed.ncbi.nlm.nih.gov/38350895