N/A
N=52
Randomized, Controlled Study to Compare Straumann® VivOss™ to Geistlich Bio-Oss® in Sinus Floor Augmentation.
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02288182 ↗Enrolled (actual)
52
Serious AEs
1.9%
Results posted
Aug 2019
Primary outcome: Primary: Ratio of Newly Formed Bone to Residual Bone Graft in Patients Treated With Straumann® VivOss™ Compared to Geistlich Bio-Oss® — 1.37; 0.69 ratio — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Straumann VivOss (Device); Geistlich Bio-Oss (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Institut Straumann AG
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ratio of Newly Formed Bone to Residual Bone Graft in Patients Treated With Straumann® VivOss™ Compared to Geistlich Bio-Oss® |
1.37; 0.69 | 0.001 sig |
| SECONDARY Survival Rate of Study Implants (Based on Subjects) |
24; 22 | — |
| SECONDARY Success Rate of Study Implants |
25; 25 | — |
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™ compared to Geistlich Bio-Oss in regards to the ratio of newly formed bone to residual bone substitute.
Eligibility Criteria
Inclusion Criteria
- 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 ) 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
Data sourced from ClinicalTrials.gov (NCT02288182). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.