Straumann Bone Ceramic Versus BioOss in Sinus Elevation

NCT ID: NCT00900822

Last Updated: 2016-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2008-12-31

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.

Conditions

Jaw, Edentulous, Partially; Alveolar Bone Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Straumann Bone Ceramic

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

Group Type: EXPERIMENTAL

Straumann Bone Ceramic

Intervention Type: DEVICE

Granules applied once during surgery

BioOss

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

Group Type: ACTIVE_COMPARATOR

BioOss

Intervention Type: DEVICE

Granules that are applied once during surgery

Interventions

Straumann Bone Ceramic

Granules applied once during surgery

Intervention Type: DEVICE

BioOss

Granules that are applied once during surgery

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Straumann AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mats Hallman, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinic for oral maxillofacial surgery, Gävle hospital, Sweden

Locations

Dr Mats Hallman

Gävle, , Sweden

Countries

Sweden

References

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.

Reference Type: RESULT

PMID: 20491816 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20162114 (View on PubMed)

Other Identifiers

CR 02/05

Identifier Type: -

Identifier Source: org_study_id