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Assessment of Sinus Floor Perforation Effect on Bone Formation During Sinus Floor Elevation
Led by Medical University of Vienna · Updated on 2022-05-11
12
Participants Needed
1
Research Sites
104 weeks
Total Duration
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AI-Summary
What this Trial Is About
This research aims to compare new bone growth after sinus floor elevation surgery in patients needing dental implants. The study focuses on whether making multiple small holes (perforations) in the cortical bone layer of the sinus floor before placing augmenting material improves bone formation. The trial involves 12 patients who require sinus floor elevation on both sides of the mouth, allowing direct comparison within each patient. Participants will undergo a lateral window sinus floor elevation on both sides. One side will follow the standard procedure by filling the sinus with augmentation material without perforation. The other side will have several perforations made in the cortical bone layer before the augmentation material is inserted to enhance blood supply to the graft. Both sides will then heal for 4 to 6 months before dental implants are placed. During implant placement, a bone biopsy will be taken from the treated areas to assess new bone formation through histological analysis. The study includes randomized assignment of sides and double-blinding to ensure unbiased results. Participants will be monitored throughout the healing period, with the main outcome measured at 4 to 6 months after surgery to compare bone growth between the two procedures.
CONDITIONS
Brief Title
Effect of Multiple Perforations of the Sinus Floor on Bone Formation After Sinus Floor Elevation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Need bilateral sinus floor elevation
- Residual alveolar ridge height between 2 and 6 millimeters
- Residual alveolar ridge width greater than 4 millimeters
You will not qualify if you...
- Uncontrolled periodontal disease
- Acute or chronic sinusitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 4 to 6 months
Participants undergo sinus floor elevation procedures with or without additional perforation of the sinus floor as part of the study interventions.
1 baseline visit and follow-up assessments over 4 to 6 months
Trial Site Locations
Total: 1 location
1
University Clinic of Dentistry, Medical University of Vienna
Vienna, Austria, 1090
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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