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 Inconsistency:
There are discrepancies in the reported sample size across different sections of the document:

o    In the Materials section, the sample size is stated as 45 premolars.

o    In the section titled “Specify the biospecimens and their amounts in your research study even if you did not collect these materials,” the sample size is listed as 42 teeth.

o    In the Informed Consent Form (page 2), it is mentioned that the study will be conducted on 21 extracted teeth.
These inconsistencies should be addressed to ensure clarity and accuracy.

 

2.      Sample Size and Group Allocation:
The reference used for calculating the sample size is unclear, and the number of specimens in each group has not been specified. Please clarify and provide appropriate references.

3.      Gantt Chart:
The Gantt chart requires corrections to improve clarity and accuracy.

4.      Flow Chart Submission:
The document submitted under the title “Flow Chart” is incorrect. Please submit the correct flow.

5-   Part IV: Safety Issues: The answer is 'No,' but the study involves the use of bacteria and lasers, both pose health risks. So, the answer should be yes.

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

 

Comment to the Committee

1.      Sample Size Inconsistency:
There are discrepancies in the reported sample size across different sections of the document:

o    In the Materials section, the sample size is stated as 45 premolars.

o    In the section titled “Specify the biospecimens and their amounts in your research study even if you did not collect these materials,” the sample size is listed as 42 teeth.

o    In the Informed Consent Form (page 2), it is mentioned that the study will be conducted on 21 extracted teeth.
These inconsistencies should be addressed to ensure clarity and accuracy.

 

2.      Sample Size and Group Allocation:
The reference used for calculating the sample size is unclear, and the number of specimens in each group has not been specified. Please clarify and provide appropriate references.

3.      Gantt Chart:
The Gantt chart requires corrections to improve clarity and accuracy.

4.      Flow Chart Submission:
The document submitted under the title “Flow Chart” is incorrect. Please submit the correct flow.

5-   Part IV: Safety Issues: The answer is 'No,' but the study involves the use of bacteria and lasers, both pose health risks. So, the answer should be yes.

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

 

Informed consent form:

Needs Modification

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