National Research Centre

Medical Research Ethics Committee

MREC Reviewer Comment

Protocol Title

Effect of Two Laser Irradiation Systems and Photodynamic Therapy-Assisted Disinfection on inhibiting Cariogenic Bacterial Growth on Prepared tooth Surfaces Before Veneer Adhesion

Completely satisfied and informative data

Needs Explanation

Comments to the applicant

1. Sample Size Section

The sample size reference is inconsistent: the reference study was conducted on humans, whereas the present study will be conducted on extracted teeth.
The sample size was initially mentioned as 45 extracted premolar teeth.
However, in the Origin of the Specimen section, it was stated as 42.
الموافقة المستنيرة (Informed consent): The sample size is mentioned as 21 extracted molars.
2 - The Gantt chart needs some modifications.
3- The flowchart is missing.

4. Health Risks of the Study

Yes, there is a health risk, as the study involves the use of bacteria and lasers.
5. Informed Consent

The study does not require الموافقة المستنيرة (informed consent).

Comment to the Committee

1. Sample Size Section

The sample size reference is inconsistent: the reference study was conducted on humans, whereas the present study will be conducted on extracted teeth.
The sample size was initially mentioned as 45 extracted premolar teeth.
However, in the Origin of the Specimen section, it was stated as 42.
الموافقة المستنيرة (Informed consent): The sample size is mentioned as 21 extracted molars.
2 - The Gantt chart needs some modifications.
3- The flowchart is missing.

4. Health Risks of the Study

Yes, there is a health risk, as the study involves the use of bacteria and lasers.
5. Informed Consent

The study does not require الموافقة المستنيرة (informed consent).

Informed consent form:

Waiver

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