Comparing two techniques for lateral sinus lift in patients with severe maxillary atrophy
"Tunnel" Flap vs Trapezoidal Flap for Lateral Sinus Lift: A Prospective Randomized Study
This study is testing which of two surgical techniques for lifting the sinus works better for people with severe bone loss in their upper jaw who need dental implants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Studio Dentistico Associato Sivolella Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Padova) |
| Trial ID | NCT06105489 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the tunnel flap technique versus the trapezoidal flap technique for performing lateral sinus lifts in patients with severe atrophy of the edentulous maxilla. The study focuses on post-operative symptoms, complication rates, and the effectiveness of bone grafting associated with each technique. Participants will undergo the lateral sinus lift procedure and will be monitored through follow-up care, including diary entries to track their recovery and any issues that arise. The goal is to determine which technique offers better outcomes for patients needing dental implants.
Who should consider this trial
Good fit: Ideal candidates include edentulous or partially edentulous patients with severe alveolar atrophy in the maxillary premolar or molar areas.
Not a fit: Patients with severe illnesses, uncontrolled diabetes, or those undergoing certain therapies like chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing lateral sinus lifts.
How similar studies have performed: While there is limited data on the tunnel flap technique specifically, similar studies have shown promising results for alternative flap techniques in sinus lift procedures.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * edentulous or partly edentulous patients with a unilateral loss of teeth in the maxillary premolar or molar areas * severe alveolar atrophy and a residual severe alveolar ridge height up to 3 mm Exclusion Criteria: * severe illness * head and neck radiation therapy * chemotherapy * antiresorptive therapy * uncontrolled diabetes * uncontrolled periodontal disease * smoking \>10 cigarettes per day * facial or neck inflammatory or oncologic diseases * obliteration of sinus ostium and osteomeatal complex
Where this trial is running
Padova
- Studio Dentistico Associato Graiff e Sivolella — Padova, Italy (Recruiting)
Study contacts
- Principal investigator: Stefano Sivolella, DDS, PhD — Studio Dentistico Associato Sivolella
- Study coordinator: Stefano Sivolella, DDS, PhD
- Email: stefano.sivolella@unipd.it
- Phone: 0039 049 652821
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.