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Trial record 3 of 107 for:    Recruiting, Not yet recruiting, Available Studies | "Bone Transplantation"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03420287
Recruitment Status : Not yet recruiting
First Posted : February 2, 2018
Last Update Posted : February 12, 2018
Information provided by (Responsible Party):
Mohamed Salah, Cairo University

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.

Condition or disease Intervention/treatment Phase
Cleft; Alveolar Process Combination Product: MPM Prepared From Allogenic Bone Graft Other: Autogenous bone Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Mineralized Plasmatic Matrix Prepared From Allogenic Bone Graft in Alveolar Cleft Closure: A Prospective Randomized, Triple Blinded, Parallel Clinical Trial
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Oro-nasal Fistula [ Time Frame: 6 months ]

    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 .

Secondary Outcome Measures :
  1. C.T analysis of secondary bone grafts [ Time Frame: 6 months ]

    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

  2. Donor site long standing pain [ Time Frame: 6 months ]

    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Unilateral or bilateral alveolar cleft patients

Exclusion Criteria:

  • patients with previous failed alveolar cleft grafting procedure.

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Responsible Party: Mohamed Salah, principal investigator, Cairo University Identifier: NCT03420287     History of Changes
Other Study ID Numbers: CEBD-CU-2018-01-02
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No