Factors Related to Early Marginal Bone Loss in Dental Implants—A Multicentre Observational Clinical Study
, Kauê Farias Collares 1, César Dalmolin Bergoli 2, Mateus Bertolini Fernandes dos Santos 2, Pedro Henrique Corazza 1,* and Mutlu Özcan 3,*Round 1
Reviewer 1 Report
I have read your revised manuscript and I regret to inform you that, although the manuscript has been improved a little bit, my main concerns have not been addressed adequately and the manuscript, at least in its current form, does not meet the criteria for novelty and impact expected.
The results appear to be too preliminary and incomplete for publication at the present time. The groups are to inconsistent, e.g. the MBL should be separately evaluated in group with bone grafts, groups with full dentures and infra-leveled, etc. Unfortunately, the authors mixed oranges with apples and tried to draw some scientific conclusions but failed. I do understand the financial aspect of implant-supported treatments and working at University, however, these are not scientifically sound reasons to be presented by researchers trying to write evidence-based papers. MBL around implants is a hot topic in modern implantology and if a paper with flaws in design and execution is published, it might be used as an erroneous argument in the discussion and do more harm than good.
I regret that the outcome could not have been more favorable in this case.
Author Response
Response to Reviewer 1 Comments
Dear Reviewer
Thank you for your reply and for considering our manuscript for publication in the Applied Sciences.
The point-by-point responses (in red text) to the comments are following.
Title: “Factors related to early marginal bone loss in dental implants - A Multicentre Observational Clinical Study”
Comments and Suggestions for Authors
I have read your revised manuscript and I regret to inform you that, although the manuscript has been improved a little bit, my main concerns have not been addressed adequately and the manuscript, at least in its current form, does not meet the criteria for novelty and impact expected.
The results appear to be too preliminary and incomplete for publication at the present time. The groups are to inconsistent, e.g. the MBL should be separately evaluated in group with bone grafts, groups with full dentures and infra-leveled, etc. Unfortunately, the authors mixed oranges with apples and tried to draw some scientific conclusions but failed. I do understand the financial aspect of implant-supported treatments and working at University, however, these are not scientifically sound reasons to be presented by researchers trying to write evidence-based papers. MBL around implants is a hot topic in modern implantology and if a paper with flaws in design and execution is published, it might be used as an erroneous argument in the discussion and do more harm than good.
I regret that the outcome could not have been more favorable in this case.
R: All considerations from the previous review were answered and used to improve the text. The results of the present study are not preliminary. They are the final results of the research, which clearly demonstrated that marginal bone loss occurs before the second surgical stage and is greater in implants with high torque.
Following the suggestions of the first revision, the authors made it clear that all implants were installed at the bone or infra bone level. All evaluations considered the period between surgery and the second surgical stage. Thus, the installation of a total or partial denture after this period was not relevant for the outcome of the present study.
Reviewer 2 Report
Dear authors,
We have read with interest your manuscript. The methods and results are clearly presented, with conclusions supported by the results. The MBL of implants is of prime interest for clinical applications.
Our main concerns are that the informations brought are not really new (MBL is directly impacted by torque during implantation), and that the multiplication of considered factors lead to subgroups with few patients (diabete, hypertension, age, sex, arch, position....)
Therefore, we have no reason not to accept your manuscript for publication, with the restriction that the overall conclusions are not really new, but confirms previous data.
Side remarks:
>> Methods section : 2.6 Measuring the distance... : "The radiographs were taken by the same operator" : We assume there were at least 2 operators (1 per clinical center)
>> Table 3 and 4 : the multiplication of considered factors dilute the main information. Additionally, we had difficulties to understand the meaning of results for Individual Level (Age, Sex): there were such significant differences?
Yours faithfully,
Author Response
Response to Reviewer 2 Comments
Dear Reviewer
Thank you for your reply and for considering our manuscript for publication in the Applied Sciences.
The point-by-point responses (in red text) to the comments are following.
Title: “Factors related to early marginal bone loss in dental implants - A Multicentre Observational Clinical Study”
Comments and Suggestions for Authors
Dear authors,
We have read with interest your manuscript. The methods and results are clearly presented, with conclusions supported by the results. The MBL of implants is of prime interest for clinical applications.
Our main concerns are that the informations brought are not really new (MBL is directly impacted by torque during implantation), and that the multiplication of considered factors lead to subgroups with few patients (diabete, hypertension, age, sex, arch, position....)
Therefore, we have no reason not to accept your manuscript for publication, with the restriction that the overall conclusions are not really new, but confirms previous data.
R: The small sample size of some groups like diabetes was discussed as a limitation of the study: “Regarding diabetes, the significance indicated in the continuous approach was not con-firmed in the dichotomous approach, probably due to the small sample size of the group with diabetes. An increase in the sample size of this group would better illustrate the initial situation of MBL in diabetic patients.”
Side remarks:
Methods section : 2.6 Measuring the distance... : "The radiographs were taken by the same operator" : We assume there were at least 2 operators (1 per clinical center)
R: Thank you. The sentence was adjusted accordingly: “The radiographs were taken by two calibrated operators (one per clinical center) and all were performed using the long cone parallelism technique”.
Table 3 and 4: the multiplication of considered factors dilute the main information. Additionally, we had difficulties to understand the meaning of results for Individual Level (Age, Sex): there were such significant differences?
R: This difference is probably not clinically significant. This point was mentioned in the discussion: “In this study, analyzing the outcome using a dichotomous approach, patient age and sex were not significant factors.”
Reviewer 3 Report
The manuscript submitted to Applied Sciences entitled “Factors related to early marginal bone loss in dental implants - A Multicentre Observational Clinical Study” is an original research article which aim to analyze the effect of clinical and patient-related factors on marginal bone loss.
On my opinion the article is interesting, well written, with good English. Anyway, there are some minor issues to address.
- English language: minor spell check required.
- Abstract: Please structure abstract to attract readers attention.
- Introduction: My main suggestion is to include a brief sentence on osseodensification technique for implant surgery using the following reference. doi: 3390/app10238623.
- Materials and Methods: This section has been properly prepared.
- Results: This section has been properly prepared.
- Discussion: This section has been properly prepared.
- Conclusion: Further studies on this topic are needed.
- Figures: Please improve quality and resolution.
- Abbreviations: Insert a summary of abbreviations used in the text prior to “Reference” section.
After making the indicated changes, the article will be suitable for publication.
Thanks for the opportunity to review this manuscript.
Author Response
Response to Reviewer 3 Comments
Dear Reviewer
Thank you for your reply and for considering our manuscript for publication in the Applied Sciences.
The point-by-point responses (in red text) to the comments are following.
Title: “Factors related to early marginal bone loss in dental implants - A Multicentre Observational Clinical Study”
Comments and Suggestions for Authors
The manuscript submitted to Applied Sciences entitled “Factors related to early marginal bone loss in dental implants - A Multicentre Observational Clinical Study” is an original research article which aim to analyze the effect of clinical and patient-related factors on marginal bone loss.
On my opinion the article is interesting, well written, with good English. Anyway, there are some minor issues to address.
English language: minor spell check required.
R: Thank you for your considerations. The English was checked.
Abstract: Please structure abstract to attract readers attention.
R: Thank you. The authors believe the abstract reflects what happened in the study.
Introduction: My main suggestion is to include a brief sentence on osseodensification technique for implant surgery using the following reference. doi: 3390/app10238623.
R: Thank you. The sentence was added to the introduction. “Bone height and density are two important parameters for a predictable successfull results in implantology. Bone compaction and osseodensification technique positively affect the primary implant stability values in cancellous bone, allowing high insertion torque”.
Materials and Methods: This section has been properly prepared.
Results: This section has been properly prepared.
Discussion: This section has been properly prepared.
Conclusion: Further studies on this topic are needed.
R: This sentence had been added to the end of the discussion. However, it was carried over to the conclusion, in accordance with the reviewer's suggestion.
Figures: Please improve quality and resolution.
R: The paper does not contain figures.
Abbreviations: Insert a summary of abbreviations used in the text prior to “Reference” section.
R: The abbreviations had been previously added prior to “Reference”.
After making the indicated changes, the article will be suitable for publication.
Thanks for the opportunity to review this manuscript.
R: Thank you.
Reviewer 4 Report
Dear authors,
Thank you for choosing me as a reviewer of this manuscript. The aim of the presented manuscript was to evaluate the effect of clinical and patient-related factors on marginal bone loss. The sample was composed of individuals treated at two dental schools in southern Brazil. I found the article very interesting. The problem is actual and the introduction section is reliable and comprehensive with an actual review of the literature. The material and methods section describes the methods used exhaustively. The discussion section could be improved in my opinion authors should consider the issue wider
The manuscript ends with the appropriate conclusions.-please remove the numbers (1,2,3….)
Authors should refill the Author Contributions, Funding, Institutional Review Board Statement, etc…..
Thank you and Best Regards to the authors
Author Response
Response to Reviewer 4 Comments
Dear Reviewer
Thank you for your reply and for considering our manuscript for publication in the Applied Sciences.
The point-by-point responses (in red text) to the comments are following.
Title: “Factors related to early marginal bone loss in dental implants - A Multicentre Observational Clinical Study”
Dear authors,
Thank you for choosing me as a reviewer of this manuscript. The aim of the presented manuscript was to evaluate the effect of clinical and patient-related factors on marginal bone loss. The sample was composed of individuals treated at two dental schools in southern Brazil. I found the article very interesting. The problem is actual and the introduction section is reliable and comprehensive with an actual review of the literature. The material and methods section describes the methods used exhaustively. The discussion section could be improved in my opinion authors should consider the issue wider
The manuscript ends with the appropriate conclusions.-please remove the numbers (1,2,3….)
Authors should refill the Author Contributions, Funding, Institutional Review Board Statement, etc…..
Thank you and Best Regards to the authors
R: Thank you. The numbers were removed from the conclusion. The requested items have been filled.
Round 2
Reviewer 1 Report
Dear Authors,
In my opinion, even though your paper is properly written when it comes to structure, it's design, presentation and execution are not good enough to be granted publication in a high impact-factor journal. So it is not about the discussion or replies to my comments, but it simply does not meet the standards of scientific soundness and its overall merit is low as I have already written in my previous comments.
This manuscript is a resubmission of an earlier submission. The following is a list of the peer review reports and author responses from that submission.
Round 1
Reviewer 1 Report
First of all I'd urge the authors to check all the numbers in the statistics really carefully as they do not add up (e.g. Table 1/ variable: smoking: 44+7+5=56; diabetes: 48+8=56; the same goes with the number of implants e.g. variable: protection). If for some reson, some patients were excluded it should be clearly stated as it influences the overall results. The description of surgical procedures is poor- there is no information regarding implant position re the bone level, bone quality in different areas and the values of IT used in these regions. Where are the results of blood tests and Vit D levels mentioned in the MM section? There is also no info regarding the antibiotics prescribed nor dosage. I do not understand why some of the loadings exceeded those mentioned in the literature- some implants were loaded after 9 months, some after 8-7-6- this is inconsistent in line 160. The article lacks in the description of managment of completely edentulous patients- if the complete dentures were used this could have influenced MBL. Why the authors did not use CBCTs to evaluate the MBL? There is also ni info on how many implants per pt were used.
The article has some potential but it needs to be completely rewritten before it may be considered for publication
Reviewer 2 Report
Dear authors.
Very good work done but the scientific repercussion is low.
You have finished the study in December 2018, the authors could have presented a follow-up of longer than 6 months.
I recommend that you reevaluate the results with a longer follow-up and can write a new article.
Best regards
Reviewer 3 Report
Dear authors,
We have read with interest your manuscript, about results from a clinical study.
The topic is of high interest, as it is a direct application from clinical situations. We appreciate all the efforts about rigorous and clear statistical analysis.
However, we have major concerns about the way you presented your study, and the results:
This is an observational study, in which you tried to consider all the factors that might have influenced the results.
But, as you said in the discussion: "It is very difficult to find so many important variables at a single study; it has some limitations" and "The procedures steps were not randomized, since the main factor of the study 'Torque' cannot be accurately predicted before the surgery. Even evaluating 226 sites, the sample size can be considered low".
By including so many variables and factors in your analysis, you cannot bring any clear conclusion, usable for further clinical applications.
i.e smoking: "There was no difference between the MBL of smoking and non-smoking patients." But we know without any doubt that smoking has a huge impact on implant results. You had only 8 smokers in your study... And you stated it in your manuscript: "This finding should be analyzed with caution due to the small size of the smoking group".
The main results, in our understanding, is the correlation between Torque and MBL. To our point of view, this is the core of your manuscript, as it might have some major implications on clinical procedures: with your results, we can conclude that 'Torque' is a predictable factor. i.e: When placing an implant with a Torque over 60 (or other high Torque), we have a weaker prognostic.
There's only few words about Torque in your 'Discussion' section: it could be of great interest to develop more why some clinical situations lead to higher (or lower) Torque.
There are too many side data given in your manuscript. This lead to a confusion about the main results and potential conclusions. Luckily, your 'Conclusion' paragraph enlighten the all study.
Our recommendation is that your manuscript should be re-written, with less factors included in the statistical analysis, to focus on the main result: Torque influence.
Reviewer 4 Report
The manuscript submitted to Applied Sciences entitled “Factors related to early marginal bone loss in dental implants - A Multicentric Observational Clinical Study” is an original research article which aim to analyze the effect of clinical and patient-related factors on marginal bone loss.
On my opinion the article is interesting, well written, with good English. Anyway, there are some minor issues to address.
- English language: Minor corrections needed.
- Introduction: My main suggestion is to include a brief sentence on osseointegration and factors that can affect it: <<Osseointegration has been defined as a direct and functional connection between bone and an artificial implant. Both bone quality and quantity could influence the success of these procedures [doi:10.23812/20-96-L-53]>>.
- Materials and Methods: Please improve. Was IRB authorization requested?
- Results: This section has been properly prepared.
- Discussion: Do Authors think that the new implant shapes and geometries can reduce early marginal bone loss?
- Conclusion: Further studies on this topic are needed.
- Figures: Please improve quality and resolution.
- Abbreviations: Insert a summary of abbreviations used in the text prior to “Reference” section.
After making the indicated changes, the article will be suitable for publication.
Thanks for the opportunity to review this manuscript.
