Alveolar Cleft Repair Using Osteoinductive Ceramics (ACROSTIC)

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

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.

Study Overview

• Status: Completed
• Conditions: Cleft Lip and Palate; Cleft Palate Children; Cleft Alveolar Ridge
• Intervention / Treatment: Device: Unilateral alveolar cleft repair

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
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Amsterdam UMC
  • Groningen, Netherlands
    • UMC Groningen
  • Nijmegen, Netherlands
    • Radboud UMC
  • Utrecht, Netherlands
    • UMC Utrecht

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• unilateral alveolar cleft, early secondary alveolar cleft closure

Exclusion Criteria:

• cleft lip and palate in a syndromic context

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: UMC Utrecht
• 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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: cleft lip; cleft palate; bone graft; alveolar cleft; calcium phosphate ceramics
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Jaw Diseases; Jaw Abnormalities; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Lip Diseases; Mouth Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cleft Lip; Cleft Palate
• Other Study ID Numbers: NL75562.041.21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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