The primary objective is to determine the efficacy of MagnetOs microstructured BCP granules in inducing adequate bone quantity and quality to support endosseous dental implants in the two-staged maxillary sinus floor augmentation procedure.…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Mond- en kaakchirurgie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Percentage of new bone formation in the augmented sinus floor by
histomorphometrical analysis of biopsy specimens at 5 months of follow up.
Secondary outcome
- Implant survival rate and adverse events during 17 months of follow up.
- Augmented bone height, volume and bone-implant-contact area (only at 11 and
17 months) in relation to the endosseous dental implant as measured by CBCT at
5, 11 and 17 months of follow up.
- Implant stability quotient (ISQ) as measured by resonance frequency analysis
(RFA) at 5 months (after implant placement) and 11 months of follow-up.
- Scoring of gingival index, supra-gingival plaque index, and dichotomous
bleeding index 17 months after surgery.
- Probing depth of implant and adjacent teeth (buccodistal, buccomedial,
buccomesial) at 17 months after surgery.
- Pain by the Visual Analogue Scale (VAS-score) at visit 2 to 6.
Background summary
Loss of teeth and molars is generally followed by resorption of the alveolar
bone. Severe alveolar bone resorption is often a major obstacle for dental
implant insertion for replacement of molars. In order to regain sufficient bone
quantity and quality for the installation of oral implants in the posterior
maxilla, the sinus floor augmentation procedure can be performed. In this
procedure, access to maxillary sinus is gained through the lateral wall of the
alveolar ridge. Subsequently the sinus floor is augmented by lifting the sinus
mucosa and placing graft material within the created space on the sinus floor.
The use of autogenous bone in sinus floor augmentations is the golden standard.
However, the surgical removal of autologous bone requires an additional
surgical site and comes with a distinct set of potential complications,
including chronic pain of the donor site. Calcium phosphate ceramics (CaP) have
been developed as synthetic bone graft substitutes that eliminate the need for
autogenous bone harvesting. MagnetOs is a novel biphasic CaP developed by Xpand
Biotechnology that due to an instructive microstructured surface has
osteoinductive capacity and can induce de novo bone formation. Therefore,
MagnetOs granules may form a very suitable alternative to autogenous bone graft
for the sinus floor augmentation procedure.
Study objective
The primary objective is to determine the efficacy of MagnetOs microstructured
BCP granules in inducing adequate bone quantity and quality to support
endosseous dental implants in the two-staged maxillary sinus floor augmentation
procedure. Secondary objective is to assess the clinical performance,
functional performance (of dental implants) and pain with the use of MagnetOs
micro-structured BCP granules in sinus augmentation.
Study design
This is a prospective clinical study to evaluate efficacy of micro-structured
BCP granules in sinus floor augmentation. The study is designed as a small
open- label, uncontrolled clinical trial.
Intervention
Patients will undergo sinus floor augmentation with Micro-structured BCP
granules as bone graft substitute. A biopsy will be obtained from the maxilla
before implant placement.
Study burden and risks
The burden is that all subjects will have to undergo additional examinations
during the regular follow-up visits. The extra examinations will include the
taking of a biopsy at 5 months, measurements of implant stability at 5 months
and 11 months post-surgery and a CBCT scan at 17 months post-surgery.
The potential risks related to this study are associated with normal sinus
augmentation surgery such as pain, infection and failure of osseointegration of
dental implants. The Micro-structured BCP granules to be used in this study
bear a CE mark and have been extensively tested in vitro and in vivo and are
found to be safe and biocompatible.
The direct benefit for the participating subjects is that micro-structured BCP
granules are a bone graft substitute and therefore no autogenous bone will have
to be harvested for the sinus augmentation procedure. This removes the
disadvantages of bone graft procedures from the treatment, including a
secondary operation site and the risk of donor site morbidities like chronic
pain and neurological complications.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
* Male or female patients aged 18-70 years
* 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
* Patient qualifies for sinus augmentation surgery
Exclusion criteria
* 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
* Psychologic instability
* 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL59565.041.16 |