No registrations found.
ID
Source
Brief title
Health condition
Maxillary sinus floor augmentation, autogenous bone, bovine bone material, oral implants
Sponsors and support
-St. Anna Hospital, Geldrop<br>
-Catharina Hospital, Eindhoven.<br>
-St. Antonius Hospital, Nieuwegein
Intervention
Outcome measures
Primary outcome
Success of the MSFA procedure determined by 1-year clinical performance of dental implants placed in augmented maxillary sinus
Secondary outcome
-Volumetric changes of the bone graft
-Histological evaluation
-Micro-computed tomography (μCT) analysis
-Patient satisfaction and pain scores regarding MSFA
-Implant survival
-Implant success
-Prosthetic success
-Complications
-Plaque, gingival and bleeding indices
-Pocket probing depth
-Peri-implant radiographic bone levels
-Volumetric changes of the bone graft
-Patients satisfaction with implant placement and prosthesis
Background summary
Insufficient bone height is a common problem in the reconstruction of the edentulous posterior maxilla prior to the placement of dental implants. To create sufficient height, maxillary sinus floor augmentation (MSFA) is performed with autogenous bone (AB) or bone substitutes, such as bovine bone mineral (BBM). AB is considered the golden standard, but has major drawbacks such as fast resorption, limited availability and considerable morbidity at the donor side. BBM might perform better then AB, but there is a lack of randomized controlled trials.
A bilateral MSFA will be performed in 46 patients with a resorbed posterior maxilla. MSFA will be performed randomly with AB harvested from mandibular ramus on one side and with BBM, mixed with some locally harvested AB chips (via existing incision for sinus elevation) on the other side.
Implant placement will be performed 4-6 months after augmentation. Second-phase surgery and implant loading will be performed 4-6 months thereafter.
The aim of this study is to assess the success of MSFA determined by 1-year clinical performance of dental implants placed in augmented maxillary sinus with solely AB versus BBM with some locally harvested AB chips.
Study objective
The succes of dental implants placed in the augmented maxillary sinus by using a bovine bone mineral (BBM) with some locally harvested AB chips, is superior to, implants placed in augmented sinuses with solely autogenous bone.
Study design
Intake, MSFA procedure, check up after two weeks, implant placement procedure, check up after two weeks, second-phase surgery, 1 month after placement of final prosthesis, 1 year after placement of final prosthesis
Intervention
The study will be designed as a multicenter, split-mouth, randomized split mouth study.: Randomisation will be carried out between two sides:
1. AB harvested from mandibular ramus
2. BBM, Cerabone (Cerabone, Botiss Dental, Berlin, Germany) mixed with approximately one-fifth locally harvested AB chips (via existing incision for sinus elevation).
B.P. Jonker
Erasmus MC Rotterdam
P.O. Box 2040, 3000 CA Rotterdam, the Netherlands
's-Gravendijkwal 230, Office D-224
Rotterdam
The Netherlands
Tel + 31 10 703 4138
e-mail: b.jonker@erasmusmc.nl
B.P. Jonker
Erasmus MC Rotterdam
P.O. Box 2040, 3000 CA Rotterdam, the Netherlands
's-Gravendijkwal 230, Office D-224
Rotterdam
The Netherlands
Tel + 31 10 703 4138
e-mail: b.jonker@erasmusmc.nl
Inclusion criteria
-18 years and older
-In need for bilateral dental implant placement in the posterior maxilla
-Bone height should be more then 2 mm and less then 5 mm
-Bone width should be over 5 mm
-Enough volume of the mandibular ramus to facilitate bone harvesting.
Exclusion criteria
Presence of clinical active periodontal disease
Acute inflammatory oral disease
Smoking
Uncontrolled diabetes
A history of radiotherapy in the head- and-neck region or current chemotherapy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL6499 |
NTR-old | NTR6686 |
Other | NL59578.078.16 : MEC 2017-001 |