National Research Centre

Medical Research Ethics Committee

MREC Reviewer Comment

Protocol Title

Assessment of Soft Tissue Healing After Alveolar Bone Grafting In Unilateral Cleft Patients Using Biosil Collagen

Completely satisfied and informative data

Needs Explanation

Comments to the applicant

The protocol needs some modifications

Comment to the Committee

The protocol needs some modifications:

الترجمة العربية تحتاج تعديل: (مقترح للعنوان العربى : تقييم شفاء الأنسجة الرخوة بعد تطعيم العظام السنخية لدى مرضى الشفة الأرنبية (الشق الأحادي الجانب) باستخدام كولاجين بيوسيل

2. The protocol has not been reviewed by a scientific review committee

3. No references were added in the background section

4. The References section contains 19 references that were not mentioned in the Background section

5. The dose of Biocell was not determined (number of tablets? Is it one tablet or more? How many milligrams does each tablet contain) during the treatment period (12 weeks)?

6. The source of Biosil Collagen has not been determined, especially since it is produced by many companies

Informed consent form:

Needs Modification

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