National Research Centre

Medical Research Ethics Committee

MREC Reviewer Comment

Protocol Title

Digital Deformation Assessment of CAD/CAM Milled Fiber-Reinforced Composite Versus Titanium Removable Partial Denture Framework: A Randomized Cross Over Clinical Trial

Completely satisfied and informative data

Needs Explanation

Comments to the applicant

The objective of the study is not clear and needs to be represented in a much comprehensive approach.

In the hypothesis, the PI states that” This hypothesis is based on several key points from the document”. Kindly elaborate what document and what are the several points?

Also, it is mentioned that” The introduction mentions that fiberglass frameworks are lighter and more aesthetic, which could potentially lead to higher patient satisfaction.” Kindly elaborate what introduction are you referring to?

The PI also mention “the study's PICO framework”, however    this framework is not included.

The background is insufficient and does not give a complete picture of the matter studied. The PI needs to give more details about the suggested technique and the available literature discussing the subject with references.

The detailed procedures are missing. The PI needs to point out, the indication for partial denture construction for each patient. Are there other therapeutic alternatives? How many visits?  And also the PI needs to mention the steps in details.

Another critical concern is the approach described “Participants will use each partial denture framework for a three-month period, followed by a two-week denture-free interval. Subsequently, patients will receive the alternative framework material for another three-month period”

The PI needs to clearly verify the need for putting the patient through this lengthy procedure and also validate with evidence that this approach will not alter or result in mucosal changes that might affect the final results.

The grouping is not clear. Are the same patients located in two groups? Kindly verify the validity of this design.

In the inclusion criteria the PI does not mention the number of missing teeth that needs to be restored.

The informed consent needs to be revised with omitting the unnecessary data, removing any terminology in English and clearly stating the procedures in details in an easy to understand manner addressed to the patient.

Comment to the Committee

Informed consent form:

Needs Modification

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