Maxillary Sinus Elevation With Bio-Oss or Straumann BoneCeramic

NCT00901121 | Completed

• 1 other identifier: CR 09/04
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 8

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.

Conditions

Teeth Loss; Bone Loss

Keywords

maxillary sinus lift; Histomorphometric evaluation; bone graft; bone augmentation

Outcome Measures

Primary Outcomes (1)

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

  180 to 240 days

Secondary Outcomes (3)

• 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.

  180 to 240 days

• Evaluation of the survival and success rate of Straumann dental implants placed in the grafted areas

  3 years

• Clinical evaluation of peri implant soft tissue

  3 years

Study Arms (2)

BoneCeramic

EXPERIMENTAL

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).

Device: Straumann BoneCeramic

Bio-Oss

ACTIVE COMPARATOR

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

Device: Bio-Oss

Interventions

Straumann BoneCeramic DEVICE

Straumann BoneCeramic (500-1000 microns, 0.5g)

BoneCeramic

Bio-Oss DEVICE

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

Bio-Oss

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Straumann AG: lead

Study Sites (8)

Private Practice

Milan, 20124, Italy

Location

University of Milan

Milan, 20142, Italy

Location

Private Practice

Naples, 80121, Italy

Location

Private Practice

Naples, 80429, Italy

Location

Private Practice

Pavia, 27100, Italy

Location

Private Practice

Rome, 00145, Italy

Location

Private Practice

Rome, 00151, Italy

Location

Eastman Dental Hospital ASL RMA Roma

Rome, 00197, Italy

Location

Related Publications (1)

• 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.

  PMID: 18705811 RESULT

MeSH Terms

Conditions

Anodontia; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Matteo Chiapasco, Prof

  University of Milan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2009
• First Posted: May 13, 2009
• Study Start: July 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: March 1, 2011
• Last Updated: March 3, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (8)