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.|
|ClinicalTrials.gov Identifier: NCT03420287|
Recruitment Status : Not yet recruiting
First Posted : February 2, 2018
Last Update Posted : February 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cleft; Alveolar Process||Combination Product: MPM Prepared From Allogenic Bone Graft Other: Autogenous bone||Early Phase 1|
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 (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- 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 .
- 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
- 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.