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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02288182
• Other study ID #: CR03/13
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: February 2018

Study information

• Verified date: August 2019
• Source: Institut Straumann AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Straumann VivOss
Patients will receive Straumann VivOss for sinus augmentation.
• Geistlich Bio-Oss
Patients will receive Geistlich Bio-Oss for sinus augmentation.

Locations

Country	Name	City	State
Germany	Zentrum für Implantologie, Parodontologie und 3D- Diagnostik	Konstanz	Baden-Württemberg
Switzerland	University of Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Institut Straumann AG

Countries where clinical trial is conducted

Germany,  Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	Survival Rate of Study Implants (Based on Subjects)	Number of implants in place	4 months +/- 1 month after implant placement
Secondary	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