Straumann Bone Ceramic Versus BioOss in Sinus Elevation

Alveolar Bone Loss Clinical Trial

Official title:

Randomized, Controlled Clinical Study to Compare Bone Formation Around Micro-implants in the Maxilla After Sinus Floor Augmentation With Straumann Bone Ceramic or Bio-Oss in a Split Mouth Design

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00900822
• Other study ID #: CR 02/05
• Status: Completed
• Phase: N/A
• First received: May 11, 2009
• Last updated: July 31, 2012
• Start date: November 2005
• Est. completion date: December 2008

Study information

• Verified date: July 2012
• Source: Institut Straumann AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 2008
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Jaw, Edentulous
• Jaw, Edentulous, Partially

Intervention

Device:
• Straumann Bone Ceramic
Granules applied once during surgery
• BioOss
Granules that are applied once during surgery

Locations

Country	Name	City	State
Sweden	Dr Mats Hallman	Gävle

Sponsors (1)

Lead Sponsor	Collaborator
Institut Straumann AG

Country where clinical trial is conducted

Sweden, 

References & 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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Implant Survival Rate	The percentage of implants remaining in the jaw.	12 months after loading the implant	No
Secondary	Implant Success Rate	Implant success is defined as the absence of any continuous peri-implant radiolucency based on radiographic findings, absence of implant mobility, absence of a recurrent per-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more 3-month follow-up visits after treatment with systemic antibiotics), and bone level changes around the implant less than 1 mm during the first year of loading and less than 0.2 mm per year thereafter.	12 months after loading the implant	No