Clinical trial NCT05331456: Alveolar Cleft Repair Using Osteoinductive Ceramics
Official title: Alveolar Cleft Repair Using Osteoinductive Ceramics in Children With Unilateral Cleft Lip and Palate
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cleft Palate Children
Cleft Alveolar Ridge
Cleft Lip and Palate
Keywords: cleft palate
cleft lip
alveolar cleft
calcium phosphate ceramics
bone graft
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Radboud University Medical Center
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Academisch Ziekenhuis Groningen
name: Medisch Centrum Leeuwarden
First posted: 2022-04-15
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stepped wedge cluster randomized trial
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* unilateral alveolar cleft, early secondary alveolar cleft closure

Exclusion Criteria:

* cleft lip and palate in a syndromic context

Primary outcomes:
measure: Bone volume
timeFrame: 1 year postoperatively
Secondary outcomes:
measure: Postoperative pain
timeFrame: Day 1 to 7 postoperatively
measure: Canine eruption
timeFrame: 1 year postoperatively
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Groningen
country: Netherlands
facility: UMC Groningen
city: Nijmegen
country: Netherlands
facility: Radboud UMC
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: UMC Utrecht
name: Nard Janssen, MD, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: