cleft lip and palate cleft palate
Conditions
Interventions
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:
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
2 Years to 15 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Netherlands
Outcome results
None listed