NCT06356870

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
0mo left

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Jun 2024Jun 2026

First Submitted

Initial submission to the registry

March 30, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

March 30, 2024

Last Update Submit

April 4, 2024

Conditions

Alveolar Cleft Grafting

Keywords

BMACalveolar cleft

Outcome Measures

Primary Outcomes (1)

  • bone density

    Assessment of bone density at the grafting site from a CT scan using Hounsfild Unit (HU)

    6 months

Secondary Outcomes (2)

  • Bone gain

    6 months

  • Postoperative donor site morbidity

    1 month

Study Arms (2)

Allograft mixed with BMAC

EXPERIMENTAL

Allograft mixed with BMAC used for alveolar cleft grafting

Procedure: BMAC MIXED WITH ALLOGRAFT

Anterior iliac crest cancellous bone only

ACTIVE COMPARATOR

Anterior iliac crest cancellous bone only used for alveolar cleft grafting

Procedure: Cancellous bone from anterior iliac crest

Interventions

BMAC MIXED WITH ALLOGRAFTPROCEDURE

Study group

Allograft mixed with BMAC
Cancellous bone from anterior iliac crestPROCEDURE

Control group

Anterior iliac crest cancellous bone only

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • alveolar cleft patients at the mixed dentition phase

You may not qualify if:

  • patients with previous alveolar grafting intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Cairo, Egypt

Location

MeSH Terms

Interventions

Transplantation, Homologous

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Central Study Contacts

Ahmed M Abdelmaksoud

CONTACT

01092490609ahmedmostafa10@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: parallel assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

March 30, 2024

First Posted

April 10, 2024

Study Start

June 1, 2024

Primary Completion

June 1, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

April 10, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)