Alveolar Cleft Hard- and Soft Tissue Reconstruction With an Autogenous Tooth Derived Particulate Graft

Semmelweis University1 site in 1 country8 target enrollmentOctober 12, 2021

ConditionsCleft Lip and Palate

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cleft Lip and Palate
Sponsor: Semmelweis University
Enrollment: 8
Locations: 1
Primary Endpoint: Radiological volumetric measurements
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The present study aims at clinical and radiographic evaluation of the safety and efficacy of Bonmaker ATB powder combined with a novel split thickness papilla curtain flap in the treatment of alveolar cleft defects.

Registry

clinicaltrials.gov

Start Date

October 12, 2021

End Date

November 1, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Semmelweis University

Responsible Party

Principal Investigator

Dr. Nagy Krisztián

Associate Professor

Semmelweis University

Eligibility Criteria

Inclusion Criteria

•children with alveolar cleft
•patient presented at least three deciduous teeth scheduled for extraction.

Exclusion Criteria

•major relevant clinical diseases,
•systemic use of steroids,
•current or previous intravenous bisphosphonate treatment,
•acute infection at the operation site.

Outcomes

Primary Outcomes

Radiological volumetric measurements

Time Frame: 6 months

Volumetric measurements will be conducted after the healing period. On prealigned pre- and postoperative CBCT cross-sections, linear measurements and volumetric measurements will be taken parallel to a reference base to determine the width of the surgical area.