Clinical trial NCT00900822: Straumann Bone Ceramic Versus BioOss in Sinus Elevation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaw, Edentulous, Partially
Alveolar Bone Loss
Keywords: bone grafting
sinus elevation
sinus augmentation
Lead sponsor: Institut Straumann AG
Sponsor class: INDUSTRY
First posted: 2009-05-13
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Histologically Measured Bone to Implant Contact (BIC)
timeFrame: 9 months after implant placement
Secondary outcomes:
measure: Implant Survival Rate
timeFrame: 12 months after loading the implant
measure: Implant Success Rate
timeFrame: 12 months after loading the implant
Other outcomes:
Locations:
city: Gävle
country: Sweden
facility: Dr Mats Hallman
Study officials:
affiliation: Clinic for oral maxillofacial surgery, Gävle hospital, Sweden
name: Mats Hallman, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.