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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Institut Straumann AG
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Histologically Measured Bone to Implant Contact (BIC)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Straumann Bone Ceramic
StraumannBone Ceramic is used as bone grafting material in sinus augmentation procedures
Intervention: Straumann Bone Ceramic (Device)
BioOss
BioOss is used as a bone grafting material in sinus augmentation procedure
Intervention: BioOss (Device)
Outcomes
Primary Outcomes
Histologically Measured Bone to Implant Contact (BIC)
Time Frame: 9 months after implant placement
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
Secondary Outcomes
- Implant Success Rate(12 months after loading the implant)
- Implant Survival Rate(12 months after loading the implant)