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Trial record 1 of 12 for:    janssen | utrecht, Netherlands | Child
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Alveolar Cleft Repair Using Osteoinductive Ceramics (ACROSTIC)

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ClinicalTrials.gov Identifier: NCT05331456
Recruitment Status : Recruiting
First Posted : April 15, 2022
Last Update Posted : December 6, 2023
Sponsor:
Collaborators:
Radboud University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Academisch Ziekenhuis Groningen
Medisch Centrum Leeuwarden
Information provided by (Responsible Party):
Nard Janssen, UMC Utrecht

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cleft Palate Children Cleft Alveolar Ridge Cleft Lip and Palate Device: Unilateral alveolar cleft repair Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Stepped wedge cluster randomized trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Alveolar Cleft Repair Using Osteoinductive Ceramics in Children With Unilateral Cleft Lip and Palate
Actual Study Start Date : June 1, 2022
Estimated Primary Completion Date : February 1, 2025
Estimated Study Completion Date : February 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Alveolar cleft repair using autologous bone from the mandibular symphysis
Control group
 Device: 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
 Device: 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


Outcome Measures
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Primary Outcome Measures :
  1. Bone volume [ Time Frame: 1 year postoperatively ]
    One year postoperative residual bone volume


Secondary Outcome Measures :
  1. Postoperative pain [ Time Frame: Day 1 to 7 postoperatively ]
    Postoperative pain on a 1 to 10 scale

  2. Canine eruption [ Time Frame: 1 year postoperatively ]
    Eruption of the canine (or lateral incisor) adjacent to the alevolar cleft


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • unilateral alveolar cleft, early secondary alveolar cleft closure

Exclusion Criteria:

  • cleft lip and palate in a syndromic context
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05331456


Contacts
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Contact: Nard Janssen, MD, DDS, PhD 0887574560 ext +31 n.g.janssen-2@umcutrecht.nl

Locations
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Netherlands
Amsterdam UMC Recruiting
Amsterdam, Netherlands
Contact: Jitske Nolte, MD, DDS, PhD         
UMC Groningen Recruiting
Groningen, Netherlands
Contact: Johan Jansma, MD, DDS, PhD         
Contact: Rutger Schepers, MD, DDS, PhD         
Radboud UMC Recruiting
Nijmegen, Netherlands
Contact: Marloes Nienhuijs, MD, DDS, PhD         
UMC Utrecht Recruiting
Utrecht, Netherlands
Contact: Nard Janssen, MD, DDS, PhD    +31887574560    n.g.janssen-2@umcutrecht.nl   
Sponsors and Collaborators
UMC Utrecht
Radboud University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Academisch Ziekenhuis Groningen
Medisch Centrum Leeuwarden
Investigators
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Principal Investigator: Nard Janssen, MD, DDS, PhD UMC Utrecht
More Information
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Responsible Party: Nard Janssen, N.G. Janssen, Prinicpal Investigator, UMC Utrecht
ClinicalTrials.gov Identifier: NCT05331456    
Other Study ID Numbers: NL75562.041.21
First Posted: April 15, 2022    Key Record Dates
Last Update Posted: December 6, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Nard Janssen, UMC Utrecht:
cleft palate
cleft lip
alveolar cleft
calcium phosphate ceramics
bone graft
Additional relevant MeSH terms:
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Cleft Palate
Cleft Lip
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
 Congenital Abnormalities
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities