Effect of Multiple Perforations of the Sinus Floor on Bone Formation After Sinus Floor Elevation
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: perforation of the sinus floor, no perforation of the sinus floor.
- Who it may be relevant to
- Registry conditions: Sinus Elevation, Dental Implant, Bone Formation. Basic parameters: 18 years — 120 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
- Austria
- 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
Assessment of the Effect of Sinus Floor Perforation During Sinus Floor Elevation on Bone Formation Within the Augmentation Material
Overview
The aim of the present study is to compare the rate of new bone formation after sinus floor elevation with or without perforation of the cortical sinus floor prior to insertion of augmentation material. Twelve patients requiring bilateral sinus floor elevation will be recruited for a pilot study in split-mouth design. On both sides a lateral window will be prepared and the sinus mucosa will be elevated. After this step, the sides are assigned as test or control side. While the control side is just filled with augmentation material, an additional step is performed for the test side, i.e., prior to inserting the augmentation material, the cortical bone layer of the sinus floor is perforated several times into the trabecular bone layer to improve the blood supply to the grafting material. Thereafter, both sides are left to healing for 4-6 months until implant installation. At timepoint of implant installation, a bone biopsy will be collected to allow histological assessment of the grafted area.
Interventions
- Procedure perforation of the sinus floor
perforation of the cortical layer of the sinus floor prior to inserting the augmentation material during sinus floor elevation - Procedure no perforation of the sinus floor
standard procedure for sinus floor elevation
Primary outcome measures
- New bone formation [Time frame: 4-6 months after sinus floor elevation]
Eligibility criteria
Inclusion criteria
- in need of bilateral sinus floor elevation
- residual alveolar ridge height 2-6mm
- residual alveolar ridge width > 4mm
Exclusion criteria
- uncontrolled periodontal disease
- acute or chronic sinusitis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Austria · 1 center
- University Clinic of Dentistry, Medical University of Vienna — Vienna
Identifiers
NCT: NCT05362136 · 1709/2016