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
Verified date | January 2018 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Cairo University |
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 |