Straumann Bone Ceramic Versus BioOss in Sinus Elevation

March 3, 2016 updated by: Institut Straumann AG

Randomized, Controlled Clinical Study to Compare Bone Formation Around Micro-implants in the Maxilla After Sinus Floor Augmentation With Straumann Bone Ceramic or Bio-Oss in a Split Mouth Design

Straumann Bone Ceramic (SBC) and BioOss will be used as bone grafting materials when there is a need for bone augmentation in the posterior upper jaw. 9 months later the bone formation is evaluated. The patients are followed for 3 years.The study hypothesis is that the SBC is not worse than BioOss.

Study Overview

Detailed Description

Straumann Bone Ceramic (SBC) and BioOss will be used as bone grafting materials when there is a need for bone augmentation in the posterior upper jaw. The bone grafting materials will be placed into the sinus cavity,(a routine procedure), one material randomly at each side and a micro-implant will be inserted simultaneously. 9 months later the micro-implant is removed and a regular Straumann SLActive implant is inserted. The micro-implant is evaluated histologically. The site is evaluated every 12 months for 3 years in regards to clinical measurements. The study hypothesis is that the SBC is not worse than BioOss.

Study design: Prospective, randomized, open, controlled, single center, split mouth

Study population: 11 male and female patients at an age of between 18 and 80 years, affected by edentulism of both lateral-posterior maxilla and presenting two pneumatized maxillary sinuses and necessitating rehabilitation with implant-supported prostheses will be recruited in the study and treated by means of maxillary sinus floor augmentation and delayed implant placement.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Gävle, Sweden, 80187
        • Dr Mats Hallman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females, 18 years to 80 years of age
  • The patients are at least partly edentulous in the both maxillary regions corresponding to the sinuses.
  • A dental implant procedure is foreseen in both maxilla regions corresponding to maxillary sinuses.
  • Patients must be expected to present a bilateral bone defect in the sinus area, which both need a sinus floor augmentation to place one or more dental implants each.
  • Residual alveolar crest height of the lateral-posterior segments of the edentulous maxilla below the floor of each of the maxillary sinuses shall be
  • less than 5 mm and at least 2 mm, as measured by Scanora - tomography Scans in the deepest floor of the sinus
  • residual alveolar crest width should be at least in average more than 4mm as measured by Scanora - tomography scans
  • Patients must be committed to the study and must sign informed consent.
  • Oral hygiene Index less than 25%

Exclusion Criteria:

  • Any systemic medical condition that could interfere with the surgical procedure or planned treatment
  • Current pregnancy at the time of recruitment
  • Physical handicaps that would interfere with the ability to perform adequate oral hygiene
  • Alcoholism or chronically drug abuse causing systemic compromize
  • Patients who smoke more than 10 cigarettes per day
  • Medication which interferes with bone formation
  • Conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability
  • Mucosal diseases such as erosive lichen planus
  • History of local radiation therapy
  • Presence of oral lesions (such as ulceration, malignancy)
  • Severe bruxing or clenching habits
  • Persistent intraoral infection
  • Previous GBR (bone graft) or dental implant treatment in the posterior segments of the upper maxilla (foreseen implant site)
  • Patients presenting clinical and radiological signs and symptoms of maxillary sinus disease
  • Existing teeth in the residual dentition with untreated endodontic problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Straumann Bone Ceramic
StraumannBone Ceramic is used as bone grafting material in sinus augmentation procedures
Granules applied once during surgery
Active Comparator: BioOss
BioOss is used as a bone grafting material in sinus augmentation procedure
Granules that are applied once during surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histologically Measured Bone to Implant Contact (BIC)
Time Frame: 9 months after implant placement
Results from morphometric measurements of percentage of new bone in contact with the total surface of the titanium implant, area of new bone and bone graft particles in contact with bone
9 months after implant placement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Survival Rate
Time Frame: 12 months after loading the implant
The percentage of implants remaining in the jaw.
12 months after loading the implant
Implant Success Rate
Time Frame: 12 months after loading the implant
Implant success is defined as the absence of any continuous peri-implant radiolucency based on radiographic findings, absence of implant mobility, absence of a recurrent per-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more 3-month follow-up visits after treatment with systemic antibiotics), and bone level changes around the implant less than 1 mm during the first year of loading and less than 0.2 mm per year thereafter.
12 months after loading the implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mats Hallman, DDS, PhD, Clinic for oral maxillofacial surgery, Gävle hospital, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

May 11, 2009

First Submitted That Met QC Criteria

May 11, 2009

First Posted (Estimate)

May 13, 2009

Study Record Updates

Last Update Posted (Estimate)

March 31, 2016

Last Update Submitted That Met QC Criteria

March 3, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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