Alveolar Cleft Reconstruction Using Bone Marrow Aspirate Concentrate and Allograft vs Iliac Cancellous Bone.

NCT ID: NCT06356870

Last Updated: 2024-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2026-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

radiographic and clinical assessment of alveolar cleft grafting using Allograft mixed with BMAC compared to the standard protocol of anterior iliac crest cancellous bone grafting

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In the study group BMAC is collected after processing of bone marrow aspirated from anterior iliac crest using a stab incision and a specialized trocar with no surgical intervention at donor site. The BMAC will be mixed with allow graft and used for alveolar cleft grafting

In the control group the standard protocol for alveolar cleft grafting will be used which is surgical exposure of the anterior iliac crest and harvesting of cancellous bone particles.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alveolar Cleft Grafting

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

parallel assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Allograft mixed with BMAC

Allograft mixed with BMAC used for alveolar cleft grafting

Group Type EXPERIMENTAL

BMAC MIXED WITH ALLOGRAFT

Intervention Type PROCEDURE

Study group

Anterior iliac crest cancellous bone only

Anterior iliac crest cancellous bone only used for alveolar cleft grafting

Group Type ACTIVE_COMPARATOR

Cancellous bone from anterior iliac crest

Intervention Type PROCEDURE

Control group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BMAC MIXED WITH ALLOGRAFT

Study group

Intervention Type PROCEDURE

Cancellous bone from anterior iliac crest

Control group

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* alveolar cleft patients at the mixed dentition phase

Exclusion Criteria

* patients with previous alveolar grafting intervention
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ahmed Moustafa Ismail Abdelmaksoud

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cairo university

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ahmed M Abdelmaksoud

Role: CONTACT

01092490609

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BUE

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Autogenous Tooth Graft for Ridge Augmentation
NCT06416605 ACTIVE_NOT_RECRUITING NA