Maxillary Sinus Elevation With Bio-Oss or Straumann BoneCeramic
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 Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
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.
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Milan, Italy, 20142
- University of Milan
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Milan, Italy, 20124
- Private Practice
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Naples, Italy, 80121
- Private Practice
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Naples, Italy, 80429
- Private Practice
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Pavia, Italy, 27100
- Private Practice
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Rome, Italy, 00145
- Private Practice
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Rome, Italy, 00151
- Private Practice
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Rome, Italy, 00197
- Eastman Dental Hospital ASL RMA Roma
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
EXPERIMENTAL: BoneCeramic
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).
|
Straumann BoneCeramic (500-1000 microns, 0.5g)
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ACTIVE_COMPARATOR: Bio-Oss
Bio-Oss spongiosa granules, size of particle 0.25-1 mm
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Bio-Oss spongiosa granules, size of particle 0.25-1 mm
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
180 to 240 days
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
180 to 240 days
|
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Evaluation of the survival and success rate of Straumann dental implants placed in the grafted areas
Time Frame: 3 years
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3 years
|
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Clinical evaluation of peri implant soft tissue
Time Frame: 3 years
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3 years
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Matteo Chiapasco, Prof, University of Milan
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (ACTUAL)
Primary Completion
Study Completion (ACTUAL)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
First Posted
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- CR 09/04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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