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NCT03420287 Clinical Trial

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

Cleft; Alveolar Process Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03420287
Other study ID # CEBD-CU-2018-01-02
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received January 28, 2018
Last updated February 8, 2018
Start date April 2018
Est. completion date April 2019

Study information
Verified date January 2018
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 56
Est. completion date April 2019
Est. primary completion date April 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years and older
Eligibility Inclusion Criteria:

- Unilateral or bilateral alveolar cleft patients

Exclusion Criteria:

- patients with previous failed alveolar cleft grafting procedure.

Study Design

Related Conditions & MeSH terms

Intervention

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
Other:
• Autogenous bone
patients will receive an autogenous bone graft from anterior iliac crest for cleft closure

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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