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

Alveolar Cleft Grafting Clinical Trial

Official title:

Combination of Bone Marrow Concentrate and Iliac Cancellous Bone Graft in Alveolar Cleft Grafting: a Clinical & Radiographic Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04414423
• Other study ID #: BMC AlvCleft
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: December 2021
• Source: Fayoum University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Twelve patients with unilateral alveolar cleft will be enrolled in this randomized comparative study.

The patients will be divided into two groups, the control (group A) who received illiac cancellous bone graft and study group who received a combination of bone marrow concentrate and illiac cancellous bone graft (group B).

Cone Beam CT (CBCT) images will be done prior to surgery to asses preoperative alveolar defect volume. Six months postoperative CBCT images will be done and postoperative newly bone formed volume and density will be evaluated and bone formation ratio (BF%) will be calculated as follows: BF% = (formed volume/alveolar defect) × 100%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 1, 2021
• Est. primary completion date: November 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

• Patients suffering from maxillary alveolar cleft

• Patient with Primary, complete cleft lip

Exclusion Criteria:

• Syndromic cases will be excluded

• Previous operated cases

Related Conditions & MeSH terms

• Alveolar Cleft Grafting

Intervention

Procedure:
• bone marrow concentrate alveolar cleft grafting
patients will undergo surgery to repair alveolar cleft with autogenous bone graft combined with bone marrow concentrate
• Autogenous alveolar grafting
patients will undergo surgery to repair alveolar cleft with autogenous bone graft

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Cairo
Egypt	Faculty of Dentistry	Fayoum

Sponsors (1)

Lead Sponsor	Collaborator
Fayoum University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	bone density	the average bone density will be measured from the CBCT	six months postoperative
Secondary	bone formation ratio	BF% = (formed volume/alveolar defect) × 100%.	six months postoperative