Status:
COMPLETED
Randomized, Controlled Study to Compare Straumann® VivOss™ to Geistlich Bio-Oss® in Sinus Floor Augmentation.
Lead Sponsor:
Institut Straumann AG
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A randomized controlled clinical trial to investigate the capability of Straumann® VivOss™ compared to Geistlich Bio-Oss in sinus floor augmentation to demonstrate superiority of Straumann® VivOss™ co...
Detailed Description
This is a prospective, randomized, controlled study. The total study duration for each patient should be 9-14 months (from screening to last visit). Enrolled subjects are randomized to one of the fol...
Eligibility Criteria
Inclusion
- Subject must have voluntarily signed the informed consent before any study related action
- Males and females with at least 18 years of age (including 18 years)
- Subject needs augmentation procedure in the sinus to prepare for implant placement.
- Subject must have a residual bone height of 2 to 4 mm.
- Adequate oral hygiene ((Full mouth plaque index (O'Leary, et al. 1972 ) \<25%) at baseline
- Adequate control of inflammation ((full mouth bleeding on probing (Ainamo and Bay 1975)) ≤25% at baseline
Exclusion
- Systemic disease that would interfere with bone or wound healing and dental implant therapy (e.g. uncontrolled diabetes)
- Systemic disease that would interfere with bone or wound healing and dental implant therapy (e.g. uncontrolled diabetes)
- Any contraindications for general bone grafting and oral surgical procedures
- Any anomalies of the sinus that could interfere with planned procedures
- History of local irradiation therapy
- Local inflammation, including untreated periodontitis
- Medical conditions requiring chronic high dose steroid therapy
- Treatment with an investigational drug or device within a 30 day period immediately prior to surgery at visit 2, or expected participation in any other investigational drug or device study during the conduct of this trial.
- Antibiotic treatment or anti-inflammatory treatment within 4 weeks prior to surgery
- History of alcoholism or drug abuse
- Immunocompromised subjects
- Subjects who smoke \>10 cigarettes per day or tobacco equivalents or chew tobacco
- Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability
- Physical or mental disabilities that would interfere with the ability to perform adequate oral hygiene
- Current pregnancy (pregnancy test) and breastfeeding women
- Secondary exclusion criterium:
- Defects of the Schneider Membrane
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2018
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT02288182
Start Date
October 1 2014
End Date
February 1 2018
Last Update
August 28 2019
Active Locations (2)
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1
Zentrum für Implantologie, Parodontologie und 3D- Diagnostik
Konstanz, Baden-Wurttemberg, Germany, 78462
2
University of Zürich
Zurich, Switzerland, 8032