Graftless TSFE Via Self-tapping Implants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Graftless Transcrestal Sinus Membrane Elevation with Simultaneous Implant Placement.
- Who it may be relevant to
- Registry conditions: Edentulous Posterior Maxilla, Maxillary Sinus Pneumatization, Alveolar Bone Atrophy. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Yemen
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Transcrestal Graftless Schneiderian Membrane Elevation by Self-tapping Dental Implant
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.
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
- Procedure Graftless 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.
Primary outcome measures
- Amount of Newly Formed Bone After Graftless Transcrestal Sinus Elevation [Time frame: 6 months after surgery]
Eligibility criteria
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.
7\. Poor oral hygiene.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Yemen · 1 center
- Department of Oral and Maxillofacial Surgery, Sana'a University — Sanaa
Publications
- 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
Identifiers
NCT: NCT07424742 · OMFS:12/06/2024