Status:
COMPLETED
Lateral Bony Wall Repositioning in Maxillary Sinus Floor Augmentation
Lead Sponsor:
Semmelweis University
Collaborating Sponsors:
NSK Europe GmbH
Botiss Medical AG
Conditions:
Maxillary Sinus Augmentation
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The aim of the present prospective randomized controlled study is to clinically and histologically investigate the safety and efficacy of bony wall repositioning compared to rotary window preparation ...
Detailed Description
40 patients were randomly divided in two study groups after radiological and clinical evaluation. Both groups received bone grafting by a xenogeneic bone substitute (BSM, cerabone, botiss biomaterials...
Eligibility Criteria
Inclusion
- at least one missing maxillary premolar or molar
- at least 7 mm crestal bone width confirmed by preoperative ConeBeam Tomography (CBCT)
- maximally 5 mm residual bone height at the sinus floor confirmed by preoperative ConeBeam Tomography (CBCT)
- full mouth plaque and bleeding scores (FMPS and FMBS) \<20%
- satisfactory patient compliance (e.g. to participate in follow-up procedures)
- signed informed consent.
Exclusion
- clinically relevant diseases (e.g.: diabetes, rheumatism cancer)
- untreated periodontitis
- systemic steroid use
- bisphosphonate use
- acute or chronic inflammatory processes
- previous endoscopic sinus surgery
- previous sinus floor elevation
- GBR-treatment at the study site
- GTR-treatment at the study site
- tooth removal within 6 weeks prior to surgery
Key Trial Info
Start Date :
March 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04811768
Start Date
March 1 2017
End Date
May 30 2018
Last Update
March 23 2021
Active Locations (1)
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1
Semmelweis University Department of Periodontology
Budapest, Hungary, 1088