National Research Centre

Medical Research Ethics Committee

MREC Reviewer Comment

Protocol Title

A comparative clinical study assessing dentin thickness and discoloration in deep carious lesions treated with Biodentine alone versus Diode Laser pre-treatment followed by Biodentine

Completely satisfied and informative data

Needs Explanation

Comments to the applicant

1- Principal and some Associate Investigators are from MIU, although not mentioned in the protocol. We need the MIU committee approval.

2- Who will perform the statistical analysis?

3- How was the sample size calculated?

4- Mention in the criteria for discontinuation, how will the participants be treated if pulp inflamation or necrosis happens.

5- Methods: will one or more tooth allowed in the same patients or one only?

6- Benefits: the benefits are not well written in the protocol, but are better in the Informed consent.

7- Benefits: Pulp vitality is not a sure benefit.

8- Negative outcomes: there is a discrepancy between this statement and and the criteria for discontinuation.

9- What are the precautions for confidentiality protection in the photography?

10- Risks: there is no research without risks. See risks in the informed consent, in addition to financial risks for the repeated follow ups, + time spent for the repeated visits.

11- What are the informed consent procedures? and how will the privacy be maintained?

12-Informed Consent Form:

- Arabic grammer and language need revision (e.g. لانه  قد تم تعاني)

- choose from the options of clinical trial, double blind, prospective

- Methods in the groups are not clear for a lay person to understand

- free treatment is not a benefit

Comment to the Committee

Informed consent form:

Needs Modification

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