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Graftless TSFE Via Self-tapping Implants

Transcrestal Graftless Schneiderian Membrane Elevation by Self-tapping Dental Implant

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07424742
Acronym
G-TSFE
Enrollment
20
Registered
2026-02-20
Start date
2024-09-09
Completion date
2026-09-09
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Bone Atrophy, Edentulous Posterior Maxilla, Maxillary Sinus Pneumatization

Keywords

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

Brief 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.

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.

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.

Sponsors

Sana'a University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

This is an open-label single-arm prospective clinical study. No masking will be applied to participants, care providers, investigators, or outcome assessors.

Intervention model description

This is a prospective single-arm clinical study in which all enrolled participants undergo transcrestal graftless sinus membrane elevation with simultaneous dental implant placement. Clinical and radiographic evaluations are performed preoperatively, immediately postoperatively, and at 6 months to assess bone formation and implant stability.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Amount of Newly Formed Bone After Graftless Transcrestal Sinus Elevation6 months after surgeryRadiographic assessment of the amount of newly formed bone in the elevated sinus space using CBCT.

Countries

Yemen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026