PONE-D-21-14369

Comparison of clinical esthetic outcomes of immediately placed implants with and without immediate provisionalization in single-tooth implants of the esthetic area: A protocol for systematic review and meta-analysis

PLOS ONE

Dear Dr. cui,

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Kind regards,

Spyridon N. Papageorgiou, DDS, Dr Med Dent

Academic Editor

PLOS ONE

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Partly

Reviewer #2: No

Reviewer #3: Yes

Reviewer #4: Yes

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2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Partly

Reviewer #2: No

Reviewer #3: Yes

Reviewer #4: Yes

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3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Reviewer #1: No

Reviewer #2: No

Reviewer #3: Yes

Reviewer #4: Yes

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4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: No

Reviewer #2: No

Reviewer #3: Yes

Reviewer #4: Yes

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5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: No

Reviewer #2: No

Reviewer #3: Yes

Reviewer #4: Yes

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6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: The study plans to evaluate immediately placed single implants in the aesthetic region. However, the manuscript is not suitable and I am sorry to suggest a reject for its publication. Major problem with the study is that the results section is missing.

Language: The standard of English in the manuscript needs to be edited.There are many errors involving spelling and grammar. The manuscript would benefit from a thorough proof-read by a writer that has experience in writing/editing English based manuscripts for empirical peer reviewed science journals.

Abstract: I found abstract quite confusing, It should be a summary of the study. While in its present form, the authors mention how they had planned the work

• Introduction should be re-checked thoroughly for English language and fluency.

• First paragraph in my opinion, is not written well and should be written more clearly. There are many mistakes effecting the flow of the text. For example:

• RCT: Please explain this abbreviation in line 83 (which is used for the first time in text).

• Material- Methods should explain how the study was conducted, so it cannot be in future tense. Please apply corrections to this major problem with the text. It can be written: The study was planned as…, the work was conducted as… etc…

• I couldn’t understand the multiple parenthesis. Line 118,121

• Line 147: Primary outcome indicators. The primary outcome of this study will be the esthetic outcome assessed by the objective index and patient satisfaction.

What is objective index? Can authors explain what they mean, it is not clear if it is PES/WES or smt additional.

• Results section is missing

Discussions

• Discussions should be re-written according to the results.

Reviewer #2: This so-called protocol is not necessary, not at all. There are well established guidelines for systematic reviews for years and years, such as the well-known PRISMA guidelines. There is no need to establish search terms: these are logically connected to the subjected being reviewed. The proposal of local databases such as Chinese databases is inadequate, as this limits the authors that can search and read eligible articles from these, namely only those who speak the language. The same is valid for the inclusion criterion establishing Chinese as one of the languages. The esthetic outcomes are very well-established in the literature, as well as the ones for implant survival and for patient reported outcome measures. The guidelines for meta-analyses are also very well established. And not everyone has Review Manager as the preferred software to conduct meta-analysis. The same is valid for RR; some do prefer to calculate OD instead. Thus, this protocol is completely not necessary and absolutely does not add any novelty, not at all.

Reviewer #3: I had the opportunity to review the manuscript entitled “Comparison of clinical esthetic outcomes of immediately placed implants with and without immediate provisionalization in single-tooth implants of the esthetic area: A protocol for systematic review and meta-analysis.” and I recommend minor revisions to consider it for publication in the journal PLOS one.

Summary:

Suggestion:

The summary appear to be well written and readable. However, there are some key point to be addressed. First of all, Could the authors clarify how the risk of bias, such as age, gender and comorbidities will be handled?.

On the other hand, could authors explain what are the major contributions of this work?, since there different systematic reviews reported in literature covering the same topic?.

There are important characteristics of the patients that have not been considered in the document, representing risks of bias, such as age, gender, and comorbidities. I believe it is important to define how that information will be handled. On the other hand, in the literature, there are different systematic reviews reported on the subject. It is essential to describe what is the difference between those articles already published with this one?. What would be the new information that this document can provide?.

Issues:

The authors presented an organized and easy to follow manuscript. However, there are several issues which need to be addressed before this paper can be accepted for publication:

I recommend using MESH words for keywords, as an example: Immediate Dental Implant Loading.

Abstract:

1. I recommend specifying the objective at the end of the background in both the abstract and the full text.

2. In line 31 of the abstract and line 108 of the materials and methods, the MEDLINE and PubMed databases are indicated separately; considering PubMed is a repository of the MEDLINE database, I find it redundant.

3. I think it is necessary to highlight information from the meta-analysis in the abstract.

4. I suggest rewriting the abstract's conclusion because it has already been mentioned in the other sections above.

Background:

1. In line 83, the reader is informed that a systematic review will be carried out with RCTs from the last years. However, in line 35 of the abstract, the article reports that the information collected will be from inception until May 2021. I think it should be clarified.

Materials and Methods:

1. In line 103, it is reported that as part of the outcomes study is the plaque index; however, it is not mentioned in the outcomes item from line 146.

2. I consider it important to provide the date on which the search strategy was conducted.

3. Are there no considerations regarding criteria such as age, gender, or comorbidities in the inclusion and exclusion criteria? Healing can be altered with pathologies such as diabetes. How will the data of these patients be managed?

4. Considering that it is a study of evidence synthesis, do you think limiting the language would not alter the evidence?

5. The exclusion criteria should not be written in the article as the antagonistic sentence of the inclusion criteria (example: numerals a and d, between lines 140 and 144).

6. In the "Study selection and data extraction" section, the reviewers evaluate the titles and abstracts of the articles; however, the evaluation of the full text was not mentioned.

7. Regarding data extraction, I suggest specifying that the data from the primary outcomes, such as those related to esthetics, or secondary outcomes, such as satisfaction, survival, and plaque index, will be extracted. On the other hand, I have some questions: will the participants' characteristics not be extracted? Age and comorbidities will not influence the healing process? Will gender not affect the esthetic perspective?

8. In addition to the above, I recommend a subgroup analysis according to the outcome measures.

9. A publication bias assessment will not be performed?

10. I believe that it is appropriate to specify for the reader the type of evaluation that GRADE does.

11. I consider it essential to write the references of the tools used in the systematic review and meta-analysis methodology.

Discussion:

1. In the literature, there are different systematic reviews reported on the subject. What is the difference between this article and those already published?.

2. In line 215 of the discussion, the objective of the article was cited. I think it should be defined at the end of the background, and it is not necessary to explicitly mention it again in the discussion.

Reviewer #4: This protocol is well structured with a systematic review that addresses an interesting topic, a review registered in PROSPERO, PRISMA checklist, methodologically correct. But, there are some parts of the text wording that can be improved.

Abstract

Page 8, Line 35- "Each database will be searched from inception to May 2021." A clearer way of writing might be: The search will be carried out in the databases for articles published until May 2021.

Introduction

Page 10, line 83- “We will conduct a systematic review and meta-analysis of many RCTs published in the past few years…” As the search was not completed, I recommend removing the “many” and replacing “past few years” with “article published until May 2021”.

Materials and Methods

Page 8, line 31-“An electronic search of MEDLINE, EMBASE, PubMed, Web of Science,” – Authors should use the term: Pubmed/Medline, as the search will not be performed separately.

Page 11, line 98- "P (population): patients immediately placed single-tooth implants in the esthetic area." What are the references used by the authors in defining the aesthetic area? In the PROSPERO protocol, the authors mention using up to the second premolar, but premolars are posterior teeth, due to the force that affects these teeth.

Page 11, line 102- “O (outcome): implant survival rate, marginal bone level changes, marginal gingival level, plaque index, probing depth, the rate of peri-implantitis or peri-implant mucositis, esthetic outcomes, and patient satisfaction. ” In this section the author can determine which outcomes are primary and which are secondary.

Page 12, line 111- “The search keywords will include”, this term can be replaced by: The search strategy will include.

Page 13, line 142- "(b) studies involving the application of any additional therapy that could have affected the healing outcomes;" Determine what these therapies are.

Discussion

Page 17, line 219- “We hope the meta-analysis can objectively evaluate the technique”. I suggest the “we rope” exclusion.

Page 17, line 224- “We will conduct the systematic review and meta-analysis according to the PRISMA statement and the Cochrane Collaboration Handbook” I suggest writing it this way: This systematic review and meta-analysis is in accordance with the PRISMA statement and the Cochrane Collaboration Handbook

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Reviewer #1: No

Reviewer #2: No

Reviewer #3: No

Reviewer #4: No

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Attachments

Attachment

Submitted filename: PLOS ONE REVIEW.docx

Comparison of clinical esthetic outcomes of immediately placed implants with and without immediate provisionalization in single-tooth implants of the esthetic area: A protocol for systematic review and meta-analysis

PONE-D-21-14369R1

Dear Dr. cui,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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Kind regards,

Spyridon N. Papageorgiou, DDS, Dr Med Dent

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #2: No

Reviewer #3: Yes

Reviewer #4: Yes

**********

2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #2: No

Reviewer #3: Yes

Reviewer #4: Yes

**********

3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

**********

4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #2: No

Reviewer #3: No

Reviewer #4: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #2: My opinion about the protocol has not changed. This protocol is completely not necessary and absolutely does not add any novelty. If PLOS One accept to publish this manuscript, it will be for exchange of money (the publication fee that is paid by the authors or their institution), because guidelines for systematic reviews are already well established for years. Instead of writing and submitting a protocol about "immediately placed implants with and without immediate provisionalization in single-tooth implants of the esthetic area", I could pretty well write very similar protocols about dental implant failure and the influence of smoking, or of bruxism, or of periodontal disease, or of radiotherapy etc. The main thing that would change is the terms of search. And I would "profit" by being the authors of multiple publications without doing much, and PLOS One would profit with the publication fee every time.

Reviewer #3: The authors applied the suggestions in the first review. Therefore, I consider that the document is suitable for publication.

Reviewer #4: The authors made the requested changes and the systematic review protocol is now clearer and easier to understand. Regarding the study methodology, the protocol is correct.

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7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #2: No

Reviewer #3: No

Reviewer #4: No