Combination of Bone Marrow Concentrate and Iliac Cancellous Bone Graft in Alveolar Cleft Grafting

NCT04414423 | Completed

• 1 other identifier: BMC AlvCleft
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study will be to analyze the newly formed bone volume and density, 6 months after alveolar cleft grafting using iliac cancellous bone graft, with and without bone marrow concentrate.

Conditions

Alveolar Cleft Grafting

Keywords

bone marrow concentrate; alveolar cleft; CBCT; Bone density; bone volume

Outcome Measures

Primary Outcomes (1)

• bone volume

  V= (A1xT) + ( A2 xT) + …….+ (An xT) where: V= volume A= area T= thickness of the axial C.T slice N=number of slices

  six months postoperative

Secondary Outcomes (2)

• bone density

  six months postoperative

• bone formation ratio

  six months postoperative

Study Arms (2)

Bone marrow concentrate

EXPERIMENTAL

Bone marrow concentrate combined with Autogenous bone graft

Procedure: bone marrow concentrate alveolar cleft grafting

autogenous bone graft

ACTIVE COMPARATOR

grafting with autogenous bone graft

Procedure: Autogenous alveolar grafting

Interventions

bone marrow concentrate alveolar cleft grafting PROCEDURE

patients will undergo surgery to repair alveolar cleft with autogenous bone graft combined with bone marrow concentrate

Bone marrow concentrate

Autogenous alveolar grafting PROCEDURE

patients will undergo surgery to repair alveolar cleft with autogenous bone graft

autogenous bone graft

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients suffering from maxillary alveolar cleft
• Patient with Primary, complete cleft lip

You may not qualify if:

• Syndromic cases will be excluded
• Previous operated cases

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (2)

Faculty of Dentistry

Al Fayyum, 63514, Egypt

Location

Faculty of Dentistry

Cairo, 21523, Egypt

Location

Related Publications (3)

• Pinheiro FHSL, Drummond RJ, Frota CM, Bartzela TN, Dos Santos PB. Comparison of early and conventional autogenous secondary alveolar bone graft in children with cleft lip and palate: A systematic review. Orthod Craniofac Res. 2020 Nov;23(4):385-397. doi: 10.1111/ocr.12394. Epub 2020 Jun 28.

  PMID: 32446283 BACKGROUND

• Ziegler CG, Van Sloun R, Gonzalez S, Whitney KE, DePhillipo NN, Kennedy MI, Dornan GJ, Evans TA, Huard J, LaPrade RF. Characterization of Growth Factors, Cytokines, and Chemokines in Bone Marrow Concentrate and Platelet-Rich Plasma: A Prospective Analysis. Am J Sports Med. 2019 Jul;47(9):2174-2187. doi: 10.1177/0363546519832003. Epub 2019 Apr 29.

  PMID: 31034242 BACKGROUND

• Shabaan AA, Salahuddin A, Aboulmagd I, Ragab R, Salah KA, Rashid A, Ayad HM, El Aty Ahmed WA, Refahee SM. Alveolar cleft reconstruction using bone marrow aspirate concentrate and iliac cancellous bone: A 12-month randomized clinical study. Clin Oral Investig. 2023 Nov;27(11):6667-6675. doi: 10.1007/s00784-023-05276-9. Epub 2023 Oct 5.

  PMID: 37794139 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor in oral & maxillofacial Surgery Department

Model Details: Eighteen patients will be divided into two equal groups. Each group comprises nine patients.

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: June 4, 2020
• Study Start: November 1, 2020
• Primary Completion: November 20, 2021
• Study Completion: December 1, 2021
• Last Updated: December 7, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)