Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2022-06-01
2025-02-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Alveolar cleft repair using autologous bone from the mandibular symphysis
Control group
Unilateral alveolar cleft repair
Early secondary alveolar cleft repair is performed in children with a unilateral alveolar cleft using eirther autologous bone or a calcium phosphate based putty
Alveolar cleft repair using a biphasic clacium phosphate putty
Study group
Unilateral alveolar cleft repair
Early secondary alveolar cleft repair is performed in children with a unilateral alveolar cleft using eirther autologous bone or a calcium phosphate based putty
Interventions
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Unilateral alveolar cleft repair
Early secondary alveolar cleft repair is performed in children with a unilateral alveolar cleft using eirther autologous bone or a calcium phosphate based putty
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
8 Years
12 Years
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Academisch Ziekenhuis Groningen
OTHER
Medisch Centrum Leeuwarden
UNKNOWN
UMC Utrecht
OTHER
Responsible Party
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Nard Janssen
N.G. Janssen, Prinicpal Investigator
Principal Investigators
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Nard Janssen, MD, DDS, PhD
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht
Locations
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Amsterdam UMC
Amsterdam, , Netherlands
UMC Groningen
Groningen, , Netherlands
Radboud UMC
Nijmegen, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Jitske Nolte, MD, DDS, PhD
Role: primary
Johan Jansma, MD, DDS, PhD
Role: primary
Rutger Schepers, MD, DDS, PhD
Role: backup
Marloes Nienhuijs, MD, DDS, PhD
Role: primary
Nard Janssen, MD, DDS, PhD
Role: primary
Other Identifiers
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NL75562.041.21
Identifier Type: -
Identifier Source: org_study_id