Evaluation of MPM Prepared From Allogenic Bone Graft in Alveolar Cleft Closure: A Prospective Randomized Clinical Trial

NCT ID: NCT03420287

Last Updated: 2018-02-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-30
• Study Completion Date: 2019-04-30

Brief Summary

The aim of this trial is to figure out the efficiency of Mineralized Plasmatic Matrix prepared from allogenic bone graft on cleft alveolus and oro-nasal fistula closure, adequate bone volume and acceptable density at the site of grafting.MPM might improve the physiological properties of allogenic bone graft and facilitate its handling and application during surgical grafting.This might decrease the need of the second surgical site for harvesting autogenous bone to be grafted with its all complications and hurdles.This trial will help the practitioners in taking the decision of using the MPM prepared from allogenic bone in alveolar cleft closure or not.

Detailed Description

Alveolar bone grafting will be performed at 6 to 12 years of age as following :

Group (A):Will undergo grafting with anterior iliac crest bone,(Control group). Group (B):Will undergo grafting with Mineralized Plasmatic Matrix prepared from allogenic bone graft (study group).

In all patients, this will be the first bone graft to be placed in the alveolar cleft. All patients will be monitored clinically and radiographically (by cone beam C.T) for up to 6 months after surgery.

Conditions

Cleft; Alveolar Process

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

MPM prepared from allogenic bone graft

All patients in this group will receive MPM prepared from allogenic bone graft

Group Type: EXPERIMENTAL

MPM Prepared From Allogenic Bone Graft

Intervention Type: COMBINATION_PRODUCT

patients will receive a sticky bone which prepared by mixing the the growth factors of the patient with allogenic bone graft for cleft closure

Autogenous bone graft group

All patients in this group will receive autogenous bone graft only

Group Type: ACTIVE_COMPARATOR

Autogenous bone

Intervention Type: OTHER

patients will receive an autogenous bone graft from anterior iliac crest for cleft closure

Interventions

MPM Prepared From Allogenic Bone Graft

patients will receive a sticky bone which prepared by mixing the the growth factors of the patient with allogenic bone graft for cleft closure

Intervention Type: COMBINATION_PRODUCT

Autogenous bone

patients will receive an autogenous bone graft from anterior iliac crest for cleft closure

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Unilateral or bilateral alveolar cleft patients

Exclusion Criteria

• patients with previous failed alveolar cleft grafting procedure.

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Salah

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

CEBD-CU-2018-01-02

Identifier Type: -

Identifier Source: org_study_id