Straumann Bone Ceramic Versus BioOss in Sinus Elevation

NCT00900822 | Completed Results

• 1 other identifier: CR 02/05
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Jaw, Edentulous, Partially; Alveolar Bone Loss

Keywords

bone grafting; sinus elevation; sinus augmentation

Outcome Measures

Primary Outcomes (1)

• 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

  9 months after implant placement

Secondary Outcomes (2)

• Implant Survival Rate

  12 months after loading the implant

• Implant Success Rate

  12 months after loading the implant

Study Arms (2)

Straumann Bone Ceramic

EXPERIMENTAL

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

Device: Straumann Bone Ceramic

BioOss

ACTIVE COMPARATOR

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

Device: BioOss

Interventions

Straumann Bone Ceramic DEVICE

Granules applied once during surgery

Straumann Bone Ceramic

BioOss DEVICE

Granules that are applied once during surgery

BioOss

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Straumann AG: lead

Study Sites (1)

Dr Mats Hallman

Gävle, 80187, Sweden

Location

Related Publications (2)

• 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.

  PMID: 20491816 RESULT

• 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.

  PMID: 20162114 RESULT

MeSH Terms

Conditions

Jaw, Edentulous, Partially; Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Jaw, Edentulous; Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases; Bone Resorption; Bone Diseases; Periodontal Atrophy; Periodontal Diseases

Results Point of Contact

• Title: Clinial Trial Manager
• Organization: Institut Straumann AG

info@straumann.com

+41 61 965 11 11

Study Officials

• Mats Hallman, DDS, PhD

  Clinic for oral maxillofacial surgery, Gävle hospital, Sweden

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: November 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: December 1, 2008
• Last Updated: March 31, 2016
• Results First Posted: August 31, 2012

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)