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Straumann Bone Ceramic Versus BioOss in Sinus Elevation

Primary Purpose

Jaw, Edentulous, Partially, Alveolar Bone Loss

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Straumann Bone Ceramic

BioOss

About this trial

This is an interventional treatment trial for Jaw, Edentulous, Partially focused on measuring bone grafting, sinus elevation, sinus augmentation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dr Mats Hallman

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Straumann Bone Ceramic

BioOss

Arm Description

StraumannBone Ceramic is used as bone grafting material in sinus augmentation procedures

BioOss is used as a bone grafting material in sinus augmentation procedure

Outcomes

Primary Outcome Measures

Histologically Measured Bone to Implant Contact (BIC)

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

Secondary Outcome Measures

Implant Survival Rate

The percentage of implants remaining in the jaw.

Implant Success Rate

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.

Full Information

NCT ID

NCT00900822

First Posted

May 11, 2009

Last Updated

March 3, 2016

Sponsor

Institut Straumann AG

1. Study Identification

Unique Protocol Identification Number

NCT00900822

Brief Title

Straumann Bone Ceramic Versus BioOss in Sinus Elevation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

November 2005 (undefined)

Primary Completion Date

June 2007 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Straumann AG

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Jaw, Edentulous, Partially, Alveolar Bone Loss

Keywords

bone grafting, sinus elevation, sinus augmentation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Straumann Bone Ceramic

Arm Type

Experimental

Arm Description

StraumannBone Ceramic is used as bone grafting material in sinus augmentation procedures

Arm Title

BioOss

Arm Type

Active Comparator

Arm Description

BioOss is used as a bone grafting material in sinus augmentation procedure

Intervention Type

Device

Intervention Name(s)

Straumann Bone Ceramic

Intervention Description

Granules applied once during surgery

Intervention Type

Device

Intervention Name(s)

BioOss

Intervention Description

Granules that are applied once during surgery

Primary Outcome Measure Information:

Title

Histologically Measured Bone to Implant Contact (BIC)

Description

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

Time Frame

9 months after implant placement

Secondary Outcome Measure Information:

Title

Implant Survival Rate

Description

The percentage of implants remaining in the jaw.

Time Frame

12 months after loading the implant

Title

Implant Success Rate

Description

Time Frame

12 months after loading the implant

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mats Hallman, DDS, PhD

Organizational Affiliation

Clinic for oral maxillofacial surgery, Gävle hospital, Sweden

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dr Mats Hallman

City

Gävle

ZIP/Postal Code

80187

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

20491816

Citation

Lindgren C, Mordenfeld A, Hallman M. A prospective 1-year clinical and radiographic study of implants placed after maxillary sinus floor augmentation with synthetic biphasic calcium phosphate or deproteinized bovine bone. Clin Implant Dent Relat Res. 2012 Mar;14(1):41-50. doi: 10.1111/j.1708-8208.2010.00224.x. Epub 2010 May 11.

Results Reference

result

PubMed Identifier

20162114

Citation

Lindgren C, Sennerby L, Mordenfeld A, Hallman M. Clinical histology of microimplants placed in two different biomaterials. Int J Oral Maxillofac Implants. 2009 Nov-Dec;24(6):1093-100.

Results Reference

result

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Straumann Bone Ceramic Versus BioOss in Sinus Elevation

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