To provide for evidence that calcium phosphate based scaffolds generate equal amounts of residual bone volume compared to the use of autologous bone grafts in unilateral alveolar cleft grafting. A secondary objective is to prove that calcium…
ID
Source
Brief title
Condition
- Congenital and hereditary disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Preoperatively and one year postoperatively routine 3D Cone beam
computertomograms are acquired. These are 3D radiological images with
significant lower radiation doses than conventional multislice CT scans. Since
approximately ten years this is considered as standard of care in all Cleft
Units in The Netherlands.
Residual bone volumes are succesively calculated using a voxel based mathching
method. (Janssen NG, Schreurs R, Bittermann GKP, Borstlap WA, Koole R, Meijer
GJ, et al. A novel semi-automatic segmentation protocol for volumetric
assessment of alveolar cleft grafting
procedures. J Craniomaxillofac Surg. 2017;45(5):685-9.21.)
Sucessively, residual bone volumes of study and control groups are compared
Secondary outcome
Secondary outcome parameters are eruption of teeth into the recontructed
alveolar cleft and pain scores one to seven days postoperatively (based on a
ten-point Visual Analog Scale)
Background summary
At an age of 8 to 12 years, the alveolar cleft is closed in children with cleft
lip and palate. An autologous bone graft, mostly harvested from the chin or
iliac crest is harvested in order to reconstruct the alveolar cleft defect.
This harvesting procedure causes pain at the donor site, inceased operating
time and can potentially cause donor site complications. To avoid this the use
of a synthetic calcium phosphate bone substitute is a logical next step.
Scientific evidence for the effectiveness of calcium phosphate bone sunstitutes
in alveolar cleft surgery is currently limited to cohort studies, case series
and case reports.
Study objective
To provide for evidence that calcium phosphate based scaffolds generate equal
amounts of residual bone volume compared to the use of autologous bone grafts
in unilateral alveolar cleft grafting. A secondary objective is to prove that
calcium phosphate based scaffolds facilitate canine eruption through the
reconstructed alveolar cleft and provide for uncomplicated orthodontic tooth
movement in the cleft region.
Study design
A stepped wedge design is applied. There are four participating centers and ech
center will switch at a certain time point from their current standard
treatment (using autologous bone grafts harvested from the chin) to the use of
a calcium phosphate based scaffold (MagnetOs Putty, a CE certified bone
substitute for maxillofacial use). The study will not randomise per patient.
Daily practise in the UMC Utrecht, where the use of bone substitutes is
considered as standard of care, shows that patients with cleft palate and their
parents favor the use of a bone substitute. However, thourough scientific
evidence for calcium phosphate scaffolds being of equal effectiveness compared
to autologous bone grafts for this particular operation is still lacking.
Inclusion will take one year. Goal is to include 30 patients in both study and
control group in order to obtain a proper power for a non-inferiority design.
Center 1 will start with the study method (use of a bone substitute) after 4
months, center 2 will change from control method to study method after 8 months
of inclusion, center 3 will do this after 12 months and center 4 after 16
months. Total inclusion time is 20 months
Intervention
The surgical procedure of alveolar cleft closure is similar in both study and
controle group. There only is a difference in the bone transplant that is
applied into the reconstructed alveolar cleft:
In the study group: A calcium phosphate based scaffold is placed in the
alveolar cleft. It will take approximately one year for the scafflod to be
fully replaced by autologous bone.
In the control group: An autologous bone graft, harvested from the patients
chin region is used.
Study burden and risks
not applicable
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
Cleft lip and palate patients with a unilateral alveolar cleft that are
eligible for early secondary alveolar closure. Timing of surgery and therefore
inclusion is based on the moment of eruption of teeth into the alveolar cleft
and usually correlates with a calendar age of 8 to 12 years
Exclusion criteria
Patients for which the time frame of early secondary alveolar closure has passed
Patients with a (craniofacial) syndrome
Patients with bilateral alveolar clefts
Patients with intellectual disability
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| CCMO | NL75562.041.21 |