MedTrace Logo

Alveolar Cleft Repair Using Osteoinductive Ceramics

NCT05331456 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Academisch Ziekenhuis Groningen

    collaborator OTHER

  • Medisch Centrum Leeuwarden

    collaborator UNKNOWN

  • Radboud University Medical Center

    collaborator OTHER

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    collaborator OTHER

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Nard Janssen, MD, DDS, PhD · UMC Utrecht

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2025-03-01
Completion
2025-03-01

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05331456 on ClinicalTrials.gov