National Research Centre

Medical Research Ethics Committee

MREC Reviewer Comment

Protocol Title

Comparing two different attachments retaining mandibular implant overdenture regarding bone changes and occlusal force distribution (Randomized Clinical Trial)

Completely satisfied and informative data

Needs Explanation

Comments to the applicant

Kindly mention the hypothesis of the study  clearly.

Please re-write the rationale and scientific validity to justify the purpose of your study.

Is the intervention proposed in this study new and is being tested for the first time or have those attachment been used before? Have those attachments and overdenture design been clinically applied?  what defines your study as clinical trial?

The background section needs to be re-presented to discuss the possible applications of the two attachments used and the pros and cons of each type as reported by previous reports.

The sample size for this type of study needs to be calculated for this study specifically and not to rely on references.

The age group of the participants of this study belongs to the older strata; please justify the need for 13 visits? What are the durations between visits? Are visits 11, 12 and 13 intended for reading taking only? What about the follow-up?

What are the possible complications of this intervention?

Concerning provisions for dealing with complications, kindly mention the proposed ways of dealing with possible complications in regards of patient’s welfare. Mentioning and reporting in the limitation of the paper is not in the benefit of the patients.

Same applies to the “Adequacy of the research site to deal with complications”. Please mention how is the research site prepared to deal with the complications.

What is the direct or potential benefit, in the present or future, for the population?

The consent form needs considerable modifications. Please refrain from using English terms in the document. Also, try to simplify the contents of the consent to be easily understood by the patients.

In the informed consent, you mention that the sponsor of the study is the ethical committee. Kindly revise

Comment to the Committee

Informed consent form:

Needs Modification

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