Graftless TSFE Via Self-tapping Implants

Sana'a University20 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Edentulous Posterior Maxilla Maxillary Sinus Pneumatization Alveolar Bone Atrophy

Interventions

Graftless Transcrestal Sinus Membrane Elevation with Simultaneous Implant PlacementPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Oral and Maxillofacial Surgery, Sana'a University

Sanaa, Sanaa Governorate, Yemen

RECRUITING

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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