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Clinical Trials/NCT05362136
NCT05362136
Recruiting
Not Applicable

Assessment of the Effect of Sinus Floor Perforation During Sinus Floor Elevation on Bone Formation Within the Augmentation Material

Medical University of Vienna1 site in 1 country12 target enrollmentMarch 23, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sinus Elevation
Sponsor
Medical University of Vienna
Enrollment
12
Locations
1
Primary Endpoint
New bone formation
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 23, 2017
End Date
December 2027
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kristina Bertl

Principal Investigator

Medical University of Vienna

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

Outcomes

Primary Outcomes

New bone formation

Time Frame: 4-6 months after sinus floor elevation

histological assessment of new bone formation after sinus floor elevation (%)

Study Sites (1)

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