Review Reports - Clinical Outcome of Class I and II Restorations with and without an Intermediary Layer of a Flowable Composite after 24 Months: A Prospective, Randomized, Split-Mouth-Designed, Controlled and Single-Blinded Clinical Trial

Round 1

Reviewer 1 Report

The article: “Clinical outcome of Class I and II restorations with and without an intermediary layer of a flowable composite after 24 months: a prospective, randomized, split-mouth designed, controlled and single-blinded clinical trial.” aim to determine whether the additional use of a flowable in combination with a nano-hybrid composite is suitable for the restoration of class I and II occlusion-bearing cavities and that the combination of both could increase the performance of the restorations.

The article could be interesting for the readers, nevertheless I suggest some improvements:

Major bias is related to the three teeth treated with Calcicur. Honestly they should have been excluded from the study.

In the exclusion criteria the authors in fact wrote: The study teeth must show sound pulpal conditions, this means teeth with signs of pulpal inflammation, endodontic treatment or direct pulp capping are excluded.

In the abstract the authors wrote:

“Three of the failed restorations were located in the test group (6.4%), none in the control group (0%)” but no explanation of which group is the control and which one is the test was made before.

The sentence: Compared to conventional flowable composites, it is characterized by increased viscosity, filler content and strength [14] seems like a commercial advertisement. I suggest the authors to remove it and to insert in materials and methods a table with characteristics. It will have the same effect in a more professional way.

The authors should remove the following sentence: “Due to these properties it is used instead of a conventional flowable composite when higher stability or increased strength is required”. It is an opinion of the authors or the company. Furthermore the authors cite a reference dated 1999 (24 years ago).

Line 72: change VOVO to VOCO

The authors could relate the finidings to the layering technique used (horizontal, oblique) comparing to low-stress modeling techniques (Scolavino S, Paolone G, Orsini G, Devoto W, Putignano A. The Simultaneous Modeling Technique: closing gaps in posteriors. Int J Esthet Dent. 2016;11(1):58-81.)

The hypothesis are not accepted or rejected in the Discussion

Author Response

Point-by-point Response Reviewer 1

First of all, thank you very much for the review and all the helpful comments to improve the manuscript.

The point-by- point response:

The article could be interesting for the readers, nevertheless I suggest some improvements:

Major bias is related to the three teeth treated with Calcicur. Honestly they should have been excluded from the study.

We have thought about this point in advance, too. In the study protocol of this prospective study we decided to include also teeth with deep carious lesions to be near the clinical reality. 15 of the 100 included teeth received indirect pulp capping using Calcicur. So the exclusion of the three teeth due to pulp capping is not confirmed by our protocol. Unfortunately, the three teeth were in the test group and following the criteria the had to be counted as failure. This point is also included in the discussion section.

This is correct. But teeth with deep carious lesions were following the study protocol also included in the study if the vitality was positive. Teeth needing direct pulp capping were excluded. 2.1. was adjusted an correction in the text were made. Thank ypu very much for this important comment. It is an important point.

In the abstract the authors wrote:

“Three of the failed restorations were located in the test group (6.4%), none in the control group (0%)” but no explanation of which group is the control and which one is the test was made before.

Thank you very much for your advice. This is a very important point. Corrections have been made.

Thank you for this comment. Indeed this is not the best way to describe it. This point was addressed and corrected. A table with the used materials was included in the material and methods section.

The references were adjusted. Thank you very much for the precise review and the helpful comment.

Line 72: change VOVO to VOCO

Thank you, we changed it.

The authors could relate the findings to the layering technique used (horizontal, oblique) comparing to low-stress modeling techniques (Scolavino S, Paolone G, Orsini G, Devoto W, Putignano A. The Simultaneous Modeling Technique: closing gaps in posteriors. Int J Esthet Dent. 2016;11(1):58-81.)

The authors of the above mentioned paper described a clinical approach, which helps to perform quick, predictable, and natural-looking occlusal modeling, reducing the need for occlusal adjustments. This is different from our dentin lining using a flowable composite to increase adaption to dentin and avoid polymerization stress. However, the reference was included and this point was added to the discussion section.

The hypothesis are not accepted or rejected in the Discussion

The discussion section was adjusted. Thank you for this helpful comment.

Reviewer 2 Report

All parts of the relevant manuscript have been written with great care. Just make the following two minor corrections.

Abstract: The conclusion sentence based on the findings should be rewritten.

Conclusion: This section should be rewritten to include more of the findings.

Author Response

Point-by-point Response Reviewer 2

All parts of the relevant manuscript have been written with great care. Just make the following two minor corrections.

Thank you very much for your inspiring comment and the review including the helpful comments to improve the manuscript.

Abstract: The conclusion sentence based on the findings should be rewritten.

Thank you very much. The conclusion I the abstract was clarified and rewritten.

Conclusion: This section should be rewritten to include more of the findings.

The conclusion is renewed and improved following this helpful comment. Please see the conclusion section.

Reviewer 3 Report

Dear Authors.

Congratulations on your work which, I found interesting. Manuscript: Clinical outcome of Class I and II restorations with and without an intermediary layer of a flowable composite after 24 months: a prospective, randomized, split-mouth designed, controlled and single-blinded clinical trial, it is well written with an adequate structure as a scientific paper demand.

I have some minor revisions to propose to you to improve your work. Please refer to the following comments:

- line 93: “and poor oral hygiene” - What does it mean? Were the patients tested for hygiene with any indicator? If so, what kind?

- line 99-100: “and radiographic 99 diagnosis if necessary”. How were asymptomatic pulpitis ruled out? Why the x-ray was not a standard in such an examination - I am especially thinking about the radiological examination after 24 months.

- lines 102-103: What equipment was used for the photography? What camera settings? Were the parameters repeatable?

- line 110: No selective enamel etching? Why were this procedure chosen?

- lines 121-122: Fluoridation of all teeth or only the filled teeth?

- discussion: Temperature changes during polymerization can cause pulpitis. Different types of materials exhibit different temperature rises. It is worth adding that the temperature change during the polymerization of composite materials depends on the mode of polymerization. You can use: Szalewski, L.; Szalewska, M.; Jarosz, P.; Woś, M.; Szymańska, J. Temperature Changes in Composite Materials during Photopolymerization. Appl. Sci. 2021, 11, 474. https://doi.org/10.3390/app11020474

- discussion: The type of polymerization of the material affects the outer layer of the composite material, which may affect the marginal integrity. It would be worth adding information that DC is also influenced by the polymerization time and the mode used. You can use: Szalewski, L.; Wójcik, D.; Sofińska-Chmiel, W.; Kuśmierz, M.; Różyło-Kalinowska, I. How the Duration and Mode of Photopolymerization Affect the Mechanical Properties of a Dental Composite Resin. Materials 2023, 16, 113. https://doi.org/10.3390/ma16010113

- conclusion: lines 374-376: This is a repeat result, not a conclusion. Please correct this as a request.

- references: More than half of the references are older than 10 years. Please consider updating it.

Author Response

Point-by-point Response Reviewer 3

First of all, thank you very much for the review and all the helpful comments to improve the manuscript.

The point-by- point response:

I have some minor revisions to propose to you to improve your work. Please refer to the following comments:

- line 93: “and poor oral hygiene” - What does it mean? Were the patients tested for hygiene with any indicator? If so, what kind?

We recorded plaque and gingiva index (please see the result section). This was also recorded while including patients. The inclusion criteria was clarified.

In our department x-ray were taken for diagnostic purpose (carious lesions, apical diagnosis and periodontal diagnosis,…). Additional x-rays to evaluate the restorations were not necessary in this study and also excluded by the ethics committee with regard to our used criteria. In case of symptoms – see the three endodontic treated teeth- additional e-rays were taken to perform endodontic treatment following clinical guidelines.

- lines 102-103: What equipment was used for the photography? What camera settings? Were the parameters repeatable?

The missing information was added in the manuscript.

- line 110: No selective enamel etching? Why were this procedure chosen?

The aim of the study was using the universal adhesive system in the self-etch modus in this investigation. This was stated in the preliminary study protocol. It was one of the side goals of this study. Adjustments in the text were made.

- lines 121-122: Fluoridation of all teeth or only the filled teeth?

Fluoridation was performed on the restored teeth; the information was added in the manuscript. Thank you for your advice.

Thank you very much for the helpful comment. This point was included in the discussion section including the above mentioned reference.

Thank you very much for the helpful comment. This point was also included in the discussion section including the above mentioned reference.

- conclusion: lines 374-376: This is a repeat result, not a conclusion. Please correct this as a request.

The conclusion section was renewed and clarified.

- references: More than half of the references are older than 10 years. Please consider updating it.

Thank you very much for the helpful comment. References were adjusted and included. See manuscript.

Round 2

Reviewer 1 Report

All the comments have been addressed