MREC Reviewer Comment
Protocol Title
Evaluation of 2 Stage Transcrestal Maxillary Sinus Lift with Osseodensification Using Allograft Versus Autogenous–Xenograft in Severely Atrophic Posterior Maxilla: A Radiographic and Histomorphometric Study
Completely satisfied and informative data
Needs Explanation
Comments to the applicant
- The Arabic title is unclear and needs revision.
- The primary and secondary objectives, as stated, are insufficiently defined and do not reflect the aim of the study. The PI is requested to restate all objectives in a measurable and outcome-specific format, clearly.
- Multiple claims in the background section are presented without supporting references. The PI is requested to provide citations for all stated data, including reported implant survival rates and bone gain outcomes attributed to osseodensification, statements regarding the comparative resorption rates of xenografts versus allografts
- The background section does not adequately distinguish between currently practiced clinical methods and the specific approach proposed in this study. The PI is requested to describe the standard of care currently used at the study site for transcrestal sinus elevation, including the grafting materials, and clearly validate how the proposed protocol differs from or builds upon current practice.
- Also, the PI needs to provide clinical and scientific justification for the specific combination of osseodensification with the two graft protocols under investigation, explaining why this comparison has not been sufficiently addressed in the existing literature
- There is a concern regarding Group B. These participants will undergo an additional donor site surgery (external oblique ridge or chin) that carries its own risks, which creates an unequal distribution between groups. This matter should be emphasized to participants and included in the informed consent.
- Moreover, the informed consent describes the study as single-blind although it was never mentioned in the protocol. The PI is requested to validate if this design is ethical in this proposed treatment, especially that Group B will undergo an additional surgical procedure that Group A will not.
- Justification is also needed regarding the immediate postoperative CBCT which poses the risk of added radiation with no direct therapeutic benefit to the patient.
- The bone core biopsy at re-entry is entirely invasive and non-therapeutic. Both the protocol and consent form must include ethical justification.
- The informed consent does not clearly address the potential risks; the written data is insufficient and does not convey the full picture.
Comment to the Committee
Informed consent form:
Needs Modification
