Alveolar Cleft Repair Using Osteoinductive Ceramics

Study Overview
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Brief Summary
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In this study, patients with unilateral cleft lip and palate are enrolled in a multicenter stepped wedge randomized trial ithat compares alveolar cleft closure using autologous bone harvested form the mandibular symphysis with an osteoinductive biphasic calcium phosphate putty.

Detailed Description
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Rationale: Patients who undergo alveolar cleft grafting have to deal with postoperative pain and comorbidity due to harvesting of autologous bone. Objective: To evaluate if using calcium phosphate based scaffolds for alveolar cleft grafting is as effective as the use of an autologous bone graft. Study design: A 'stepped wedge' randomized controlled trial will be conducted by four centres. Study population: Children between the ages of 8 to 12 years with a unilateral alveolar cleft. Intervention: Study group undergoes alveolar cleft grafting with the use of a calcium phosphate based scaffold, the control group undergoes the same procedure, but with the use of an autologous chin bone graft. Main study parameters/endpoints: Main study outcome is one year postoperative residual bone volume in the reconstructed alveolar cleft. Secondary objectives of importance are postoperative pain and eruption of the tooth adjacent to the cleft through the reconstructed area. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients in the control group will undergo a procedure that is currently seen as the gold standard. Patients in the study group will undergo the exact same risks as the control group, except there is no risk for donor site morbidity and postoperative pain is significantly less. Postoperative clinical and radiological evaluation of both groups is according to current treatment standards.

Official Title
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Alveolar Cleft Repair Using Osteoinductive Ceramics in Children With Unilateral Cleft Lip and Palate

Conditions
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Cleft Palate Children, Cleft Alveolar Ridge, Cleft Lip and Palate

Intervention / Treatment
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* Device: Unilateral alveolar cleft repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: unilateral alveolar cleft, early secondary alveolar cleft closure Exclusion Criteria: cleft lip and palate in a syndromic context

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Stepped wedge cluster randomized trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Alveolar cleft repair using autologous bone from the mandibular symphysis<br>Control group | Device: Unilateral alveolar cleft repair<br>* Early secondary alveolar cleft repair is performed in children with a unilateral alveolar cleft using eirther autologous bone or a calcium phosphate based putty<br>|
| Other: Alveolar cleft repair using a biphasic clacium phosphate putty<br>Study group | Device: Unilateral alveolar cleft repair<br>* Early secondary alveolar cleft repair is performed in children with a unilateral alveolar cleft using eirther autologous bone or a calcium phosphate based putty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone volume | One year postoperative residual bone volume | 1 year postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Postoperative pain on a 1 to 10 scale | Day 1 to 7 postoperatively | 
| Canine eruption | Eruption of the canine (or lateral incisor) adjacent to the alevolar cleft | 1 year postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cleft palate, cleft lip, alveolar cleft, calcium phosphate ceramics, bone graft