Microstructured BCP might be a suitable substitute to autologous bone graft in the sinus floor augmentation procedure
ID
Bron
Verkorte titel
Aandoening
Maxillary sinus floor augmentation, sinus pneumatization, maxillary atrophy, maxillaire sinusbodem elevatie, maxillaire atrophy, sinus penumatisatie
Ondersteuning
- European Union’s Horizon 2020 research and innovation program (grant agreement no. 674282)
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Percentage of new bone formation in the augmented sinus floor by histomorphometrical analysis of biopsy specimens at 5 months of follow up.
Achtergrond van het onderzoek
Loss of teeth and molars is generally followed by alveolar bone resorption, which may lead to reduced bone height in the posterior maxilla. In order to regain bone volume in the posterior maxilla to allow for the placement of dental implants, maxillary sinus floor elevation is a common procedure. In this procedure, autologous bone graft is implanted on the bony floor of the maxillary sinus to increase the bone height. However, since the harvesting of autologous bone is associated with pain and donor-site morbidity, alternative strategies are being pursued. The current study compares a commercial bone graft substitute material called MagnetOs Granules versus the gold standard bone autograft in the maxillary sinus floor elevation procedure. The goal of this clinical trial is to determine whether MagnetOs Granules, a biphasic calcium phosphate ceramic with submicron surface topography, is an effective alternative to the gold standard for sinus floor elevation. A total of 30 patients will be included at the UMC Utrecht of which 15 patients shall be treated with MagnetOs Granules and 15 patients with bone autograft. Study endpoints will include the analysis of new bone formation in the sinus floor from biopsies, micro-CT analysis, implant stability measurements, gingival health check, patient-reported pain and adverse events, during a follow-up period of 17 months.
Doel van het onderzoek
Microstructured BCP might be a suitable substitute to autologous bone graft in the sinus floor augmentation procedure
Onderzoeksopzet
0, 5, 11, 17 months post-surgery
Onderzoeksproduct en/of interventie
Patients will undergo sinus floor augmentation with either autologous bone graft or with micro-structured BCP granules.
Publiek
A.J.W.P. Rosenberg
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31 88 75 577 51
A.J.W.P.Rosenberg@umcutrecht.nl
Wetenschappelijk
A.J.W.P. Rosenberg
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31 88 75 577 51
A.J.W.P.Rosenberg@umcutrecht.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Male or female patients aged 18-75 years
- Patient is willing to give informed consent to participate in the study
- Patient qualifies for sinus augmentation surgery
- Presence of a unilateral or bilateral (partial) maxillary edentulism involving the premolar/molar areas
- Presence of a residual posterior maxillary bone height between 2 and 6 mm
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Maxillary sinus pathology
- Presence of a local or systemic disease or treatment affecting bone formation
- Contamination of the (area around the) operative field
- Periodontitis
- Infectious diseases
- Bone metabolic disease
- Neurological disorders that could influence mental validity
- Smoking
- Female of child bearing potential, who are pregnant or breast-feeding
- Cancer therapy including immune-suppression, chemotherapy and radiation
- Patients in which primary stability could not be established
- Previous entry into this study or participation in any other clinical trial within 30 days
Opzet
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In overige registers
Register | ID |
---|---|
NTR-new | NL6434 |
NTR-old | NTR7225 |
CCMO | NL61242.041.17 |
OMON | NL-OMON47531 |