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