Alveolar cleft repair using osteoinductive ceramics in children with unilateral cleft lip and palate

Recruiting

Conditions: cleft lip and palate
10027664
cleft palate

Registration Number: NL-OMON54352

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 60

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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Preoperatively and one year postoperatively routine 3D Cone beam<br /><br>computertomograms are acquired. These are 3D radiological images with<br /><br>significant lower radiation doses than conventional multislice CT scans. Since<br /><br>approximately ten years this is considered as standard of care in all Cleft<br /><br>Units in The Netherlands.<br /><br><br /><br>Residual bone volumes are succesively calculated using a voxel based mathching<br /><br>method. (Janssen NG, Schreurs R, Bittermann GKP, Borstlap WA, Koole R, Meijer<br /><br>GJ, et al. A novel semi-automatic segmentation protocol for volumetric<br /><br>assessment of alveolar cleft grafting<br /><br>procedures. J Craniomaxillofac Surg. 2017;45(5):685-9.21.)<br /><br><br /><br>Sucessively, residual bone volumes of study and control groups are compared</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome parameters are eruption of teeth into the recontructed<br /><br>alveolar cleft and pain scores one to seven days postoperatively (based on a<br /><br>ten-point Visual Analog Scale)</p><br>