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

NCT03420287 | Unknown Early Phase 1 DMC

• 1 other identifier: CEBD-CU-2018-01-02
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cleft; Alveolar Process

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• C.T analysis of secondary bone grafts

  6 months

• Donor site long standing pain

  6 months

Study Arms (2)

MPM prepared from allogenic bone graft

EXPERIMENTAL

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

Combination Product: MPM Prepared From Allogenic Bone Graft

Autogenous bone graft group

ACTIVE COMPARATOR

All patients in this group will receive autogenous bone graft only

Other: Autogenous bone

Interventions

MPM Prepared From Allogenic Bone Graft 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

MPM prepared from allogenic bone graft

Autogenous bone OTHER

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

Autogenous bone graft group

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral or bilateral alveolar cleft patients

You may not qualify if:

• patients with previous failed alveolar cleft grafting procedure.

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: January 28, 2018
• First Posted: February 5, 2018
• Study Start: April 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: February 12, 2018

Record last verified: 2018-01