Clinical trial NCT02288182: Randomized, Controlled Study to Compare Straumann® VivOss™ to Geistlich Bio-Oss® in Sinus Floor Augmentation.
Official title: A Randomized Controlled Clinical Trial to Investigate the Capability of Straumann® VivOss™ Compared to Geistlich Bio-Oss® in Sinus Floor Augmentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Sinus augmentation procedure
Lead sponsor: Institut Straumann AG
Sponsor class: INDUSTRY
First posted: 2014-11-11
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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™ compared to Geistlich Bio-Oss in regards to the ratio of newly formed bone to residual bone substitute.

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 following groups:

1. Sinus floor elevation with Straumann® VivOss™
2. Sinus floor elevation with Geistlich Bio-Oss®

In total 6 visits per patient are scheduled in this study. The histological evaluation of the ratio of newly formed bone to residual bone graft, survival and success rate of study implants and adverse events (AEs) will be assessed.

The study devices Straumann® VivOss™ and Geistlich Bio-Oss are CE-(Conformité Européenne, meaning European Conformity) marked products.

Two centers, one in Germany and one in Switzerland will participate.

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 ) \<25%) at baseline
* Adequate control of inflammation ((full mouth bleeding on probing (Ainamo and Bay 1975)) ≤25% at baseline

Exclusion Criteria:

* 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

Primary outcomes:
measure: Ratio of Newly Formed Bone to Residual Bone Graft in Patients Treated With Straumann® VivOss™ Compared to Geistlich Bio-Oss®
timeFrame: 6 months +/- 7 days after bone augmentation
Secondary outcomes:
measure: Survival Rate of Study Implants (Based on Subjects)
timeFrame: 4 months +/- 1 month after implant placement
measure: Success Rate of Study Implants
timeFrame: 4 months +/- 1 month after implant placement
Other outcomes:
measure: Basic Bone Situation
timeFrame: 6 months +/- 7 days after bone augmentation
Locations:
city: Konstanz
country: Germany
facility: Zentrum für Implantologie, Parodontologie und 3D- Diagnostik
state: Baden-Württemberg
city: Zürich
country: Switzerland
facility: University of Zürich
Study officials:
affiliation: University of Zurich
name: Ronald Jung, PD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buser D, Weber HP, Lang NP. Tissue integration of non-submerged implants. 1-year results of a prospective study with 100 ITI hollow-cylinder and hollow-screw implants. Clin Oral Implants Res. 1990 Dec;1(1):33-40. doi: 10.1034/j.1600-0501.1990.010105.x.