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

Evaluation of Mineralized Plasmatic Matrix Prepared From Allogenic Bone Graft in Alveolar Cleft Closure: A Prospective Randomized, Triple Blinded, Parallel Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Cleft; Alveolar Process
• Intervention / Treatment: Combination product: MPM Prepared From Allogenic Bone Graft; Other: Autogenous bone

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.

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Unilateral or bilateral alveolar cleft patients

Exclusion Criteria:

• patients with previous failed alveolar cleft grafting procedure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MPM prepared from allogenic bone graft; All patients in this group will receive MPM prepared from allogenic bone graft	Combination product: 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
Active Comparator: Autogenous bone graft group; All patients in this group will receive autogenous bone graft only	Other: Autogenous bone; patients will receive an autogenous bone graft from anterior iliac crest for cleft closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oro-nasal Fistula	it will be assessed visually and by questionnaire with binary measuring unit (present or not).• Examination of oro-nasal Fistula will be done by using the following diagnostic criteria: 1.Air escape from the opening when patient blows his/her nose. 2.An obvious communication between the opening and floor of the nasal cavity. 3.Unobstructed penetration of Guttapercha through the opening into the nasal cavity. 4.Hypernasality of voice due to audible nasal air escape during speech. 5.Nasal regurgitation of fluids. 6.Food lodgement into nasal cavity with risk of rhinitis .	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C.T analysis of secondary bone grafts	it will be assessed by Chelsea Scale which radio-graphically analyzing the position of the bone tissue in relation to the teeth adjacent to the cleft and separating the images into 6 categories: A,B,C,D, E,F. Bone grafts of types A,B and C according to the Chelsea scale were considered satisfactory, whereas the other types were considered unsatisfactory	6 months
Donor site long standing pain	it will be assessed by Numeric Rating Scale (NRS).Numeric Rating ScaleUsing the NPRS which is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. (NRS).0 means no pain, 5 means moderate pain and 10 means worst possible pain.	6 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2018
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: January 28, 2018
• First Submitted That Met QC Criteria: January 28, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): February 12, 2018
• Last Update Submitted That Met QC Criteria: February 8, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: CEBD-CU-2018-01-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No