Delayed Secondary Reconstruction of Alveolar Clefts Using Autogenous Symphyseal Particulate Bone Versus Iliac Cancellous Bone: A Randomized Clinical Trial

June 7, 2024 updated by: Mohamed Shawky, Cairo University
Patients with alveolar clefts whose ages are after 12 years (after eruption of all permanent dentition) were recruited and treated either by particulate bone grafting from the symphysis or from the anterior iliac crest

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • cleft alveolus patients of both genders after eruption of all permanent dentition

Exclusion Criteria:

  • previous failed repairs of alveolar clefts and bone metabolic diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Symphyseal bone group
Procedure: alveolar cleft Grafting from the symphysis
grafting using particulate bone from the symphysis
Active Comparator: iliac cancellous bone group
Procedure: alveolar cleft Grafting from the iliac cancellous bone
grafting using iliac cancellous bone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
bone volume in the reconstructed cleft site
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

June 7, 2024

First Submitted That Met QC Criteria

June 7, 2024

First Posted (Actual)

June 12, 2024

Study Record Updates

Last Update Posted (Actual)

June 12, 2024

Last Update Submitted That Met QC Criteria

June 7, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Cairo uni research

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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