Alveolar Cleft Repair Using Osteoinductive Ceramics (ACROSTIC)

• ClinicalTrials.gov Identifier: NCT05331456
• Recruitment Status: Recruiting
• First Posted: April 15, 2022
• Last Update Posted: December 6, 2023
• Sponsor: UMC Utrecht
• 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

Tracking Information

• First Submitted Date: April 11, 2022
• First Posted Date: April 15, 2022
• Last Update Posted Date: December 6, 2023
• Actual Study Start Date: June 1, 2022
• Estimated Primary Completion Date: February 1, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 11, 2022)

Bone volume [ Time Frame: 1 year postoperatively ]

One year postoperative residual bone volume

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 21, 2022)

• Postoperative pain [ Time Frame: Day 1 to 7 postoperatively ]
  Postoperative pain on a 1 to 10 scale
• Canine eruption [ Time Frame: 1 year postoperatively ]
  Eruption of the canine (or lateral incisor) adjacent to the alevolar cleft

Original Secondary Outcome Measures (submitted: April 11, 2022)

• Postoperative pain [ Time Frame: Day 1 to 7 postoperatively ]
  Postoperative pain
• Canine eruption [ Time Frame: 1 year postoperatively ]
  Eruption of the canine (or lateral incisor) adjacent to the alevolar cleft

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Alveolar Cleft Repair Using Osteoinductive Ceramics
• Official Title: Alveolar Cleft Repair Using Osteoinductive Ceramics in Children With Unilateral Cleft Lip and Palate
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Stepped wedge cluster randomized trial

Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment

Condition

• Cleft Palate Children
• Cleft Alveolar Ridge
• Cleft Lip and Palate

Intervention

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

Study Arms

• Alveolar cleft repair using autologous bone from the mandibular symphysis
  Control group
  Intervention: Device: Unilateral alveolar cleft repair
• Alveolar cleft repair using a biphasic clacium phosphate putty
  Study group
  Intervention: Device: Unilateral alveolar cleft repair

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 11, 2022): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 1, 2025
• Estimated Primary Completion Date: February 1, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• unilateral alveolar cleft, early secondary alveolar cleft closure

Exclusion Criteria:

• cleft lip and palate in a syndromic context

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 8 Years to 12 Years (Child)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT05331456
• Other Study ID Numbers: NL75562.041.21
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Nard Janssen, UMC Utrecht
• Original Responsible Party: Nard Janssen, UMC Utrecht, N.G. Janssen, MD, DDS, PhD
• Current Study Sponsor: UMC Utrecht
• Original Study Sponsor: Same as current

Collaborators

• Radboud University Medical Center
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Academisch Ziekenhuis Groningen
• Medisch Centrum Leeuwarden

Investigators

• Principal Investigator: Nard Janssen, MD, DDS, PhD; UMC Utrecht

• PRS Account: UMC Utrecht
• Verification Date: November 2023