Graftless TSFE Via Self-tapping Implants

NCT07424742 | Recruiting

• 1 other identifier: OMFS:12/06/2024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Edentulous Posterior Maxilla; Maxillary Sinus Pneumatization; Alveolar Bone Atrophy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months after surgery

Study Arms (1)

Graftless Transcrestal Sinus Lift with Simultaneous Implant Placement

EXPERIMENTAL

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

Interventions

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.

Graftless Transcrestal Sinus Lift with Simultaneous Implant Placement

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sana'a University: lead

Study Sites (1)

Department of Oral and Maxillofacial Surgery, Sana'a University

Sanaa, Sanaa Governorate, 00000, Yemen

RECRUITING

Related Publications (1)

• Albadani MM, Elayah SA, Al-Wesabi MA, Al-Aroomi OA, Al Qadasy NE, Saleh H. A graftless maxillary sinus lifting approach with simultaneous dental implant placement: a prospective clinical study. BMC Oral Health. 2024 Feb 13;24(1):227. doi: 10.1186/s12903-024-03949-9.

  PMID: 38350895 RESULT

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label single-arm prospective clinical study. No masking will be applied to participants, care providers, investigators, or outcome assessors.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Researcher, Faculty of Dentistry, Sana'a University

Model Details: 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.

Study Record Dates

• First Submitted: February 14, 2026
• First Posted: February 20, 2026
• Study Start: September 9, 2024
• Primary Completion: March 3, 2026
• Study Completion (Estimated): September 9, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• 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.
• 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.

Locations

YE (1)