Relevance of the Operator’s Experience in Conditioning the Static Computer-Assisted Implantology: A Comparative In Vitro Study with Three Different Evaluation Methods

Round 1

Reviewer 1 Report

Dear authors,
Congratulations for your work. The research has merit and relevance, however there are several aspects that need improvement before full consideration for publication.

Abstract

 - the structure of the abstract needs to be reviewed. The results section is subjective and needs to provide some values in a more objective way. It is not clear whether there is a conclusion section in the abstract or if it is a mere expansion of the results.

Introduction

- This section provides sufficient evidence for the reader with good contextualization of the topic, however there is a need to improve the English. I highly recommend a thorough review of the entire manuscript by an English native speaker.

- More recent studies and systematic reviews can be referenced in regards to fully-guided surgery, guided system, IOS, etc.; to improve scientific soundness.

Yogui FC, Verri FR, de Luna Gomes JM, Lemos CAA, Cruz RS, Pellizzer EP. Comparison between computer-guided and freehand dental implant placement surgery: A systematic review and meta-analysis. Int J Oral Maxillofac Surg. 2021 Feb;50(2):242-250. doi: 10.1016/j.ijom.2020.08.004. Epub 2020 Sep 10. PMID: 32921557.

Siqueira R, Galli M, Chen Z, Mendonça G, Meirelles L, Wang HL, Chan HL. Intraoral scanning reduces procedure time and improves patient comfort in fixed prosthodontics and implant dentistry: a systematic review. Clin Oral Investig. 2021 Dec;25(12):6517-6531. doi: 10.1007/s00784-021-04157-3. Epub 2021 Sep 27. PMID: 34568955; PMCID: PMC8475874.

Oh KC, Shim JS, Park JM. In Vitro Comparison between Metal Sleeve-Free and Metal Sleeve-Incorporated 3D-Printed Computer-Assisted Implant Surgical Guides. Materials (Basel). 2021 Jan 29;14(3):615. doi: 10.3390/ma14030615. PMID: 33572781; PMCID: PMC7866124.

Siqueira R, Chen Z, Galli M, Saleh I, Wang HL, Chan HL. Does a fully digital workflow improve the accuracy of computer-assisted implant surgery in partially edentulous patients? A systematic review of clinical trials. Clin Implant Dent Relat Res. 2020 Dec;22(6):660-671. doi: 10.1111/cid.12937. Epub 2020 Sep 22. PMID: 32964614.

 

Material and methods

- there is missing information on the workflow followed for guide fabrication including design and printing.

- was the guide a bone-supported-guide, design on the surface of a dicom converted to stl file? The information on the type of guide and workflow followed is not clear.

- authors mentioned the inclusion of eleven acrylic models and later 6 models and a half were assigned to each group. Were 11 or 13 models included? What is the total of models and implants per group?

- did the same operator that placed the implants also secured the guides with a fixation pin? Was any extra step introduced to verify guide correct position? The source of deviation can come from both guide stabilization and implant placement. This should be addressed as a limitation since we could not evaluate in which step is the deviation occurring. 

- Was any sort of training on the implant guided system provided to the non-experienced operator? How were the operators calibrated?

- Authors mentioned the implants were placed independently in different sittings. How many sessions did it take for each operator to place all implants? How much time there was in between sessions? Were the number an interval of sessions comparable between the groups?

- How was the operative time recorded? Was there any standardization for start and end time? 

Statistical Analysis

- What was the sample size derived from the calculation provided by the authors?

Results

- Authors mentioned that both dentists reduced the operative timings over time. What was the magnitude of this improvement? Was it statistically significant? Provide values.

- There are two tables 4. In the second table for the heading "Intervallo" is not written in English.

Discussion

- This section is too long and cumbersome to read. Authors should focus on discussing the main objectives of the study avoiding repeating too much results and methodology from previous studies as enough background was provided in the introduction. Again, thorough review of the English is needed.

 

Conclusion

"The starting experience and the improvement over time resulted significantly relevant in implementing the implant placement reliability." This statement shouldn't be present in the conclusion since data was not provided on the improvement in operative time throughout the performance of the experiments. 

Author Response

Dear authors,

Congratulations for your work. The research has merit and relevance, however there are several aspects that need improvement before full consideration for publication.

Abstract

- the structure of the abstract needs to be reviewed. The results section is subjective and needs to provide some values in a more objective way. It is not clear whether there is a conclusion section in the abstract or if it is a mere expansion of the results.

Answer. The abstract was modified according to the Reviewer's comments. In particular, the resulting data on the accuracy has been reported, and a conclusion paragraph has been added. The English was corrected.

 

Introduction

- This section provides sufficient evidence for the reader with good contextualization of the topic, however there is a need to improve the English. I highly recommend a thorough review of the entire manuscript by an English native speaker.

- More recent studies and systematic reviews can be referenced in regards to fully-guided surgery, guided system, IOS, etc.; to improve scientific soundness.

Yogui FC, Verri FR, de Luna Gomes JM, Lemos CAA, Cruz RS, Pellizzer EP. Comparison between computer-guided and freehand dental implant placement surgery: A systematic review and meta-analysis. Int J Oral Maxillofac Surg. 2021 Feb;50(2):242-250. DOI: 10.1016/j.ijom.2020.08.004. Epub 2020 Sep 10. PMID: 32921557.

Siqueira R, Galli M, Chen Z, Mendonça G, Meirelles L, Wang HL, Chan HL. Intraoral scanning reduces procedure time and improves patient comfort in fixed prosthodontics and implant dentistry: a systematic review. Clin Oral Investig. 2021 Dec;25(12):6517-6531. DOI: 10.1007/s00784-021-04157-3. Epub 2021 Sep 27. PMID: 34568955; PMCID: PMC8475874.

Oh KC, Shim JS, Park JM. In Vitro Comparison between Metal Sleeve-Free and Metal Sleeve-Incorporated 3D-Printed Computer-Assisted Implant Surgical Guides. Materials (Basel). 2021 Jan 29;14(3):615. DOI: 10.3390/ma14030615. PMID: 33572781; PMCID: PMC7866124.

Siqueira R, Chen Z, Galli M, Saleh I, Wang HL, Chan HL. Does a fully digital workflow improve the accuracy of computer-assisted implant surgery in partially edentulous patients? A systematic review of clinical trials. Clin Implant Dent Relat Res. 2020 Dec;22(6):660-671. DOI: 10.1111/cid.12937. Epub 2020 Sep 22. PMID: 32964614.

Answer. The suggested studies have been organically enclosed in the paper and reported in the bibliography. The English has been reviewed.

 

 

 

 

Material and methods

- there is missing information on the workflow followed for guide fabrication including design and printing.

- was the guide a bone-supported-guide, designed on the surface of a dicom converted to STL file? The information on the type of guide and workflow followed is not clear.

Answer. Yes, it was. We specified better in the text.

 

- authors mentioned the inclusion of eleven acrylic models and later 6 models and a half were assigned to each group. Were 11 or 13 models included? What is the total of models and implants per group?

Answer. We apologize for the mistake. The model number for each operator was five and a half, for a total of eleven models. A total of 44 implants were placed by each operator. The text has been corrected accordingly.

 

- did the same operator that placed the implants also secured the guides with a fixation pin? Was any extra step introduced to verify guide correct position? The source of deviation can come from both guide stabilization and implant placement. This should be addressed as a limitation since we could not evaluate in which step is the deviation occurring.

Answer. We completely agree with the Reviewer's observation. We specified in the text that the more experienced operator fixed the guides to models, and the models were randomly assigned to each operator.

 

- Was any sort of training on the implant guided system provided to the non-experienced operator? How were the operators calibrated?

Answer. The non-experienced operator, theoretically aware of the procedure, was completely novice to general dental practice and implantology and did not take part in the planning phase. It was the first time for him to place implants even in vitro. No particular calibration had been applied since no method in the literature has been reliably ratified. We specified in the text.

 

- Authors mentioned the implants were placed independently in different settings. How many sessions did it take for each operator to place all implants? How much time was there in between sessions? Were the number and interval of sessions comparable between the groups?

Answer. The implants were placed in five consecutive sessions for each operator corresponding to the number of the models, including in the last session the half-part of the eleventh shared phantom.

The operators worked in the same emplacement, starting the unexpert one, with 15 minutes of intervals between each session. We added this information to the text.

 

- How was the operative time recorded? Was there any standardization for start and end time?

Answer. An external assessor managed the timer, and the counting was started for each implant site preparation and implant placement at the motor switch on and off. Every phase time was added to subsequent with a total value calculated for each implant site management. The statistical comparison between the two operators was accomplished considering the meantime for operative sitting on five models for each dentist, excluding the last shared model. We added this information in the text.

 

Statistical Analysis

- What was the derived from the calculation provided by the authors?

Answer. For the accuracy evaluation, the sample size was calculated considering an alpha error of 0,05, a power of 0,80, and an f-effect size of 0,40 considering the literature data effect. For this reason, a total of 88 implants was considered, distributed on eleven models. This consideration had been reported in the text yet. Regarding the operative timings, since no precedents are in the literature, the mean time of model management was considered on a total of 10 models and 80 implants.

We specified in the text.

 

 

 

Results

- Authors mentioned that both dentists reduced the operative timings over time. What was the magnitude of this improvement? Was it statistically significant? Provide values.

Answer. Since the magnitude of this improvement was not calculated, we prefer not to report this data. The relative observation has been erased.

 

- There are two tables 4. In the second table for the heading "Intervallo" is not written in English.

Answer. The errors have been corrected.

 

 

 

Discussion

- This section is too long and cumbersome to read. Authors should focus on discussing the main objectives of the study, avoiding repeating too many results and methodology from previous studies as enough background was provided in the introduction. Again, a thorough review of the English is needed.

Answer. The discussion was substantially modified according to the Reviewer's suggestion and the English revised.

 

 

Conclusion

"The starting experience and the improvement over time resulted significantly relevant in implementing the implant placement reliability." This statement shouldn't be present in the conclusion since data was not provided on the improvement in operative time throughout the performance of the experiments.

Answer. The sentence refers to the accuracy and not to the treatment time shortening. This datum is reported in the Results and table 4. We have specified this in the text.

 

 

Reviewer 2 Report

Dear Author, study is good but needs minor modifications - recheck English sentences and keep sentences short.; describe in chart the various software used in study, its use and alternative,; describe the limitations of study,; too many short forms are used so, describe them in the footnote in tables so the reader can relate it easily. discussion is very long, modify it. what is the need of study or importance of study - please describe in introduction clearly.

 

Author Response

 

Dear Author, study is good but needs minor modifications –

1- recheck English sentences and keep sentences short.;

2- describe in chart the various software used in the study, its use and alternative,;

3- describe the limitations of study,;

4- too many short forms are used so, describe them in the footnote in tables so the reader can relate it easily.

5- discussion is very long, modify it.

6- what is the need of study or importance of study - please describe in the introduction clearly.

Answer. The paper has been rewritten according to the Reviewer's suggestion. A graphic has been added to explain the flowchart. The discussion was rewritten to be more concise and focused on the topic, outlining the objectives, the merits and the limits of the study. The form was corrected, and the paper underwent a new English revision.

 

 

 

Round 2

Reviewer 2 Report

Dear authors,

congratulations for study

Author Response

Thank you for your effort in correcting our paper. The inappropriate citations have been removed.