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
Verified date | July 2012 |
Source | Institut Straumann AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Medical Products Agency |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Dr Mats Hallman | Gävle |
Lead Sponsor | Collaborator |
---|---|
Institut Straumann AG |
Sweden,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05470673 -
Autogenous Demineralized Dentin Graft Combined With Injectable PRF + Metronidazole Versus Autogenous Demineralized Dentin Graft Alone for Alveolar Ridge Preservation
|
N/A | |
Recruiting |
NCT02580721 -
The Influence of Mucosal Tissue Thickness on Soft and Hard Tissue Changes Around Implants
|
N/A | |
Completed |
NCT02515058 -
Ridge Preservation Following Tooth Extraction Using Two Mineralized Cancellous Bone Allografts
|
N/A | |
Enrolling by invitation |
NCT02209311 -
Effectiveness and Safety of Method of Maxilla Alveolar Process Reconstruction Using Synthetic Tricalcium Phosphate and Autologous MMSCs
|
Phase 1/Phase 2 | |
Completed |
NCT02602223 -
Comparison of Amnion Chorion Membrane vs. Dense Polytetrafluoroethylene Membrane in Ridge Preservation Procedures
|
Phase 2 | |
Completed |
NCT02255149 -
A Feasibility Study for Growth Bone Vertically With Titanium Mesh and Allograft in Lower Posterior Jaw
|
N/A | |
Recruiting |
NCT05674331 -
Clinical, Radiographical, Histological Evaluation and Blood Flow Analysis of Alveolar Ridge Preservation
|
N/A | |
Recruiting |
NCT06081296 -
Dimensional Changes in Alveolar Ridge Preservation
|
N/A | |
Completed |
NCT03944811 -
Bone Height Gain Following Transcrestal Sinus Floor Elevation Using Piezoelectric Surgery Versus The Conventional Osteotome Technique
|
N/A | |
Completed |
NCT03045458 -
Associations of Alveolar Bone Loss and Interleukin-1β Levels in One and Two Stage Surgical Procedures
|
N/A | |
Completed |
NCT05595746 -
Radiological Bone Loss on Different Levels of Dental Implants
|
N/A | |
Completed |
NCT03357705 -
Effectiveness in Limiting the Need to Elevate the Maxillary Sinus
|
N/A | |
Recruiting |
NCT05311735 -
Mineralized and Partial Demineralized Dentin Graft Compared to FDBA
|
N/A | |
Completed |
NCT05494476 -
Stability of the Marginal Bone Around Subcrestal Implants
|
N/A | |
Not yet recruiting |
NCT05536479 -
Evaluation of Autogenous Stored Versus Autogenous Fresh Mineralized Dentin Graft for Alveolar Ridge Preservation
|
N/A | |
Active, not recruiting |
NCT02275767 -
Histological Evaluation of Healing Following Ridge Preservation Using a Combined Cortical/Cancellous Mineralized Freeze-Dried Bone Allograft
|
N/A | |
Active, not recruiting |
NCT02120053 -
Interest of Bone Substitute Material in Immediate Complete Denture
|
Phase 2/Phase 3 | |
Completed |
NCT01728844 -
GUIDOR® Growth Factor Enhanced Bone Graft Substitute for the Treatment of Periodontal Defects 6-months Post-Surgery
|
N/A | |
Terminated |
NCT00991432 -
Localized Alveolar Ridge Augmentation With Space Maintenance Devices
|
N/A | |
Terminated |
NCT00991965 -
Localized Alveolar Ridge Augmentation With Dental Implant
|
N/A |