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Maxillary Sinus Elevation With Bio-Oss or Straumann BoneCeramic

Primary Purpose

Teeth Loss, Bone Loss

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Straumann BoneCeramic
Bio-Oss
Sponsored by
Institut Straumann AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Teeth Loss focused on measuring maxillary sinus lift, Histomorphometric evaluation, bone graft, bone augmentation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males and females were at least 18 years of age and not more than 70 years old
  • A dental implant procedure was foreseen in the maxilla region corresponding to maxillary sinus
  • Patients presented a bone defect in the sinus area, which needed a sinus floor elevation to place one or more dental implants
  • The patients were unilaterally or bilaterally edentulous in the maxillary region corresponding to the sinuses
  • Residual alveolar crest height of the lateral-posterior segments of the edentulous maxilla below the floor of the maxillary sinus was less than 8 mm and at least 3 mm, measured by CT scans. Furthermore, residual alveolar crest width should be at least in average 6 mm measured by the CT scans
  • Patients were committed to the study
  • Patients were healthy at time of surgery

Exclusion Criteria:

  • Medical conditions requiring prolonged use of steroids
  • Standard blood test performed by the medical practitioner of the patient showing: leukocyte dysfunction and deficiencies
  • Haemophilia, bleeding disorders or cumarin therapy
  • History of neoplastic disease requiring the use of chemotherapy
  • History of radiation therapy to the head and neck
  • Patients with history of renal failure or chronic renal diseases
  • Patients affected by chronic liver diseases
  • Patients with severe or uncontrolled metabolic bone disorders
  • Uncontrolled endocrine disorders (including diabetes)
  • Current pregnancy at the time of recruitment
  • Physical handicaps that would interfere with the ability to perform adequate oral hygiene
  • Use of any investigational drug or device within the 90 days period immediately prior to implant surgery on study day 0
  • Alcoholism or chronically drug abuse causing systemic compromisation
  • Immunocompromised patients including patients infected with HIV
  • Patients who smoke more than 10 cigarettes per day or cigar equivalents, or who chew tobacco
  • 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

Local exclusion criteria

  • Local inflammation, including untreated periodontitis to residual dentition
  • 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
  • Patients with inadequate oral hygiene or unmotivated for adequate home care
  • Unhealed extraction sites in the upper premolar or molar area
  • Last tooth extraction performed less than 3 months before surgery 1
  • Previous GBR (guided bone regeneration) or dental implant treatment in the lateral-posterior segments of the upper maxilla (foreseen implant site)
  • Patients presenting clinical and radiological signs and symptoms of maxillary sinus disease
  • Patients presenting with residual alveolar crest height of the lateral-posterior segments of the edentulous maxilla below the floor of the maxillary sinus less than 3 mm and residual alveolar crest width less than 6 mm (measured by the CT scans)
  • The reduction in residual bone height was determined by sinus pneumatization and not by vertical resorption of the residual alveolar crest with increased interarch distance. Patients with increased interarch distance were excluded from the study
  • Existing teeth in the residual dentition with untreated endodontic or cariologic problems
  • Horizontal or vertical augmentation to correct the vertical inter-arch distance or to correct horizontal defects

Sites / Locations

  • Private Practice
  • University of Milan
  • Private Practice
  • Private Practice
  • Private Practice
  • Private Practice
  • Private Practice
  • Eastman Dental Hospital ASL RMA Roma

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BoneCeramic

Bio-Oss

Arm Description

Straumann BoneCeramic is a fully synthetic bone graft substitute of medical grade purity in particulate form composed of biphasic calcium phosphate - a mixture of 60% hydroxylapatite and of 40% of the beta form of tricalcium phosphate (beta-TCP).

Bio-Oss spongiosa granules, size of particle 0.25-1 mm

Outcomes

Primary Outcome Measures

Histological evaluation of the ratio between new bone and residual graft material at the implant site 180 to 240 days after graft-placement.

Secondary Outcome Measures

Histomorphometric evaluation of the amount of new bone, soft tissue and remaining graft in the treatment, control and in a 1mm compartment 1mm close to the autogenous bone and the amount of new bone on contact with the graft.
Evaluation of the survival and success rate of Straumann dental implants placed in the grafted areas
Clinical evaluation of peri implant soft tissue

Full Information

First Posted
May 11, 2009
Last Updated
March 2, 2016
Sponsor
Institut Straumann AG
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1. Study Identification

Unique Protocol Identification Number
NCT00901121
Brief Title
Maxillary Sinus Elevation With Bio-Oss or Straumann BoneCeramic
Official Title
Maxillary Sinus Grafting With Bio-Oss or Straumann Bone Ceramic Followed by Delayed Placement of Straumann Dental Implants: A Comparative Histomorphometric and Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Straumann AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study was to test a clinically relevant non-inferiority of Straumann BoneCeramic treatment compared to Bio-Oss treatment 180 to 240 days after sinus grafting procedure.
Detailed Description
This is a prospective, controlled, randomised, multicenter study. The total study duration for each patient should be three years. In total 13 visits per patient are scheduled in this study. The study device Straumann Bone Ceramic is CE-marked. Height centers in Italy will participate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Teeth Loss, Bone Loss
Keywords
maxillary sinus lift, Histomorphometric evaluation, bone graft, bone augmentation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BoneCeramic
Arm Type
Experimental
Arm Description
Straumann BoneCeramic is a fully synthetic bone graft substitute of medical grade purity in particulate form composed of biphasic calcium phosphate - a mixture of 60% hydroxylapatite and of 40% of the beta form of tricalcium phosphate (beta-TCP).
Arm Title
Bio-Oss
Arm Type
Active Comparator
Arm Description
Bio-Oss spongiosa granules, size of particle 0.25-1 mm
Intervention Type
Device
Intervention Name(s)
Straumann BoneCeramic
Intervention Description
Straumann BoneCeramic (500-1000 microns, 0.5g)
Intervention Type
Device
Intervention Name(s)
Bio-Oss
Intervention Description
Bio-Oss spongiosa granules, size of particle 0.25-1 mm
Primary Outcome Measure Information:
Title
Histological evaluation of the ratio between new bone and residual graft material at the implant site 180 to 240 days after graft-placement.
Time Frame
180 to 240 days
Secondary Outcome Measure Information:
Title
Histomorphometric evaluation of the amount of new bone, soft tissue and remaining graft in the treatment, control and in a 1mm compartment 1mm close to the autogenous bone and the amount of new bone on contact with the graft.
Time Frame
180 to 240 days
Title
Evaluation of the survival and success rate of Straumann dental implants placed in the grafted areas
Time Frame
3 years
Title
Clinical evaluation of peri implant soft tissue
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females were at least 18 years of age and not more than 70 years old A dental implant procedure was foreseen in the maxilla region corresponding to maxillary sinus Patients presented a bone defect in the sinus area, which needed a sinus floor elevation to place one or more dental implants The patients were unilaterally or bilaterally edentulous in the maxillary region corresponding to the sinuses Residual alveolar crest height of the lateral-posterior segments of the edentulous maxilla below the floor of the maxillary sinus was less than 8 mm and at least 3 mm, measured by CT scans. Furthermore, residual alveolar crest width should be at least in average 6 mm measured by the CT scans Patients were committed to the study Patients were healthy at time of surgery Exclusion Criteria: Medical conditions requiring prolonged use of steroids Standard blood test performed by the medical practitioner of the patient showing: leukocyte dysfunction and deficiencies Haemophilia, bleeding disorders or cumarin therapy History of neoplastic disease requiring the use of chemotherapy History of radiation therapy to the head and neck Patients with history of renal failure or chronic renal diseases Patients affected by chronic liver diseases Patients with severe or uncontrolled metabolic bone disorders Uncontrolled endocrine disorders (including diabetes) Current pregnancy at the time of recruitment Physical handicaps that would interfere with the ability to perform adequate oral hygiene Use of any investigational drug or device within the 90 days period immediately prior to implant surgery on study day 0 Alcoholism or chronically drug abuse causing systemic compromisation Immunocompromised patients including patients infected with HIV Patients who smoke more than 10 cigarettes per day or cigar equivalents, or who chew tobacco 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 Local exclusion criteria Local inflammation, including untreated periodontitis to residual dentition 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 Patients with inadequate oral hygiene or unmotivated for adequate home care Unhealed extraction sites in the upper premolar or molar area Last tooth extraction performed less than 3 months before surgery 1 Previous GBR (guided bone regeneration) or dental implant treatment in the lateral-posterior segments of the upper maxilla (foreseen implant site) Patients presenting clinical and radiological signs and symptoms of maxillary sinus disease Patients presenting with residual alveolar crest height of the lateral-posterior segments of the edentulous maxilla below the floor of the maxillary sinus less than 3 mm and residual alveolar crest width less than 6 mm (measured by the CT scans) The reduction in residual bone height was determined by sinus pneumatization and not by vertical resorption of the residual alveolar crest with increased interarch distance. Patients with increased interarch distance were excluded from the study Existing teeth in the residual dentition with untreated endodontic or cariologic problems Horizontal or vertical augmentation to correct the vertical inter-arch distance or to correct horizontal defects
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matteo Chiapasco, Prof
Organizational Affiliation
University of Milan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Private Practice
City
Milan
ZIP/Postal Code
20124
Country
Italy
Facility Name
University of Milan
City
Milan
ZIP/Postal Code
20142
Country
Italy
Facility Name
Private Practice
City
Naples
ZIP/Postal Code
80121
Country
Italy
Facility Name
Private Practice
City
Naples
ZIP/Postal Code
80429
Country
Italy
Facility Name
Private Practice
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Private Practice
City
Rome
ZIP/Postal Code
00145
Country
Italy
Facility Name
Private Practice
City
Rome
ZIP/Postal Code
00151
Country
Italy
Facility Name
Eastman Dental Hospital ASL RMA Roma
City
Rome
ZIP/Postal Code
00197
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18705811
Citation
Cordaro L, Bosshardt DD, Palattella P, Rao W, Serino G, Chiapasco M. Maxillary sinus grafting with Bio-Oss or Straumann Bone Ceramic: histomorphometric results from a randomized controlled multicenter clinical trial. Clin Oral Implants Res. 2008 Aug;19(8):796-803. doi: 10.1111/j.1600-0501.2008.01565.x.
Results Reference
result

Learn more about this trial

Maxillary Sinus Elevation With Bio-Oss or Straumann BoneCeramic

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