Alveolar Cleft Repair Using Osteoinductive Ceramics

Cleft Lip and Palate Clinical Trial

— ACROSTIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05331456
• Other study ID #: NL75562.041.21
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: February 1, 2025

Study information

• Verified date: November 2023
• Source: UMC Utrecht
• Contact: Nard Janssen, MD, DDS, PhD
• Phone: 0887574560
• Email: n.g.janssen-2[@]umcutrecht.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

• unilateral alveolar cleft, early secondary alveolar cleft closure

Exclusion Criteria:

• cleft lip and palate in a syndromic context

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate
• Cleft Palate
• Cleft Palate Children

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

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC	Amsterdam
Netherlands	UMC Groningen	Groningen
Netherlands	Radboud UMC	Nijmegen
Netherlands	UMC Utrecht	Utrecht

Sponsors (5)

Lead Sponsor	Collaborator
UMC Utrecht	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Academisch Ziekenhuis Groningen, Medisch Centrum Leeuwarden, Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone volume	One year postoperative residual bone volume	1 year postoperatively
Secondary	Postoperative pain	Postoperative pain on a 1 to 10 scale	Day 1 to 7 postoperatively
Secondary	Canine eruption	Eruption of the canine (or lateral incisor) adjacent to the alevolar cleft	1 year postoperatively