Randomized, Controlled Study to Compare Straumann® VivOss™ to Geistlich Bio-Oss® in Sinus Floor Augmentation.

A Randomized Controlled Clinical Trial to Investigate the Capability of Straumann® VivOss™ Compared to Geistlich Bio-Oss® in Sinus Floor Augmentation

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Straumann VivOss; Device: Geistlich Bio-Oss

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Konstanz, Baden-Württemberg, Germany, 78462
      • Zentrum für Implantologie, Parodontologie und 3D- Diagnostik
• Switzerland
  • Zürich, Switzerland, 8032
    • University of Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Straumann VivOss; Straumann® VivOss™Straumann® VivOss™, is a synthetic bone graft substitute in granulated form. It consists of > 90% TCP (Tri-Calcium-Phosphate -Ca3(PO4)2) and < 10% Hydroxyapatite (Ca10(PO4)6 (OH)2). The granules have a size of 250-1000 μm.	Device: Straumann VivOss; Patients will receive Straumann VivOss for sinus augmentation.
Active Comparator: Geistlich Bio-Oss; The control device is Geistlich Bio-Oss® spongiosa granules (Geistlich Pharma AG, Wolhusen, Switzerland), 0.25-1 mm in diameter. It's a natural bone mineral of bovine origin. It shall be used according to the instructions of the manufacturer.	Device: Geistlich Bio-Oss; Patients will receive Geistlich Bio-Oss for sinus augmentation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratio of Newly Formed Bone to Residual Bone Graft in Patients Treated With Straumann® VivOss™ Compared to Geistlich Bio-Oss®	Bone biopsies and histological staining	6 months +/- 7 days after bone augmentation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival Rate of Study Implants (Based on Subjects)	Number of implants in place	4 months +/- 1 month after implant placement
Success Rate of Study Implants	Buser success criteria: Absence of persisting subjective discomfort such as pain, foreign body perception and or dysaesthesia (painful sensation); Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics); Absence of implant mobility on manual palpation; Absence of any continuous peri-implant radiolucency.	4 months +/- 1 month after implant placement

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Basic Bone Situation	This measure describes the basic bone situation of the patients at baseline, i.e. the bone thickness as a unit of area before the application of bone substitute material.	6 months +/- 7 days after bone augmentation

Collaborators and Investigators

• Sponsor: Institut Straumann AG
• Investigators: Principal Investigator: Ronald Jung, PD, University of Zurich

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: October 28, 2014
• First Submitted That Met QC Criteria: November 6, 2014
• First Posted (Estimate): November 11, 2014

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 26, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Sinus augmentation procedure
• Other Study ID Numbers: CR03/13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No