NCT05331456

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 15, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

December 6, 2023

Status Verified

November 1, 2023

Enrollment Period

2.7 years

First QC Date

April 11, 2022

Last Update Submit

November 29, 2023

Conditions

Cleft Palate ChildrenCleft Alveolar RidgeCleft Lip and Palate

Keywords

cleft palatecleft lipalveolar cleftcalcium phosphate ceramicsbone graft

Outcome Measures

Primary Outcomes (1)

  • Bone volume

    One year postoperative residual bone volume

    1 year postoperatively

Secondary Outcomes (2)

  • Postoperative pain

    Day 1 to 7 postoperatively

  • Canine eruption

    1 year postoperatively

Study Arms (2)

Alveolar cleft repair using autologous bone from the mandibular symphysis

OTHER

Control group

Device: Unilateral alveolar cleft repair

Alveolar cleft repair using a biphasic clacium phosphate putty

OTHER

Study group

Device: Unilateral alveolar cleft repair

Interventions

Unilateral alveolar cleft repairDEVICE

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 puttyAlveolar cleft repair using autologous bone from the mandibular symphysis

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • unilateral alveolar cleft, early secondary alveolar cleft closure

You may not qualify if:

  • cleft lip and palate in a syndromic context

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

UMC Groningen

Groningen, Netherlands

RECRUITING

Radboud UMC

Nijmegen, Netherlands

RECRUITING

UMC Utrecht

Utrecht, Netherlands

RECRUITING

MeSH Terms

Conditions

Cleft LipCleft Palate

Condition Hierarchy (Ancestors)

Lip DiseasesMouth DiseasesStomatognathic DiseasesMouth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesJaw AbnormalitiesJaw DiseasesMusculoskeletal DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal Abnormalities

Study Officials

  • Nard Janssen, MD, DDS, PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nard Janssen, MD, DDS, PhD

CONTACT

0887574560n.g.janssen-2@umcutrecht.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Stepped wedge cluster randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
N.G. Janssen, Prinicpal Investigator

Study Record Dates

First Submitted

April 11, 2022

First Posted

April 15, 2022

Study Start

June 1, 2022

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

December 6, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

NL(4)