Quality of Life Following Dental Rehabilitation with Customized Subperiosteal Implants: A Pilot Cohort Study

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

Dear Authors, 

Thanks for the opportunity to review your paper titled "

Quality of life following dental rehabilitation with customized 2

subperiosteal implants: Α cohort study"

 and I appreciate the effort you've put into your research.

The  aim of this study was to assesses oral health-related quality of life in patients with subperiosteal implants

My concerns: 

1. The introduction should be improved according to the recent publication 
2. A comprehensive and thorough explanation of these implants is required
3. Methods and materials: no sample size was performed 
4. the outcomes are of limited significance
5. The results are clearly reported
6. The discussion should be improved in accordance with other articles on the topic
7. The strength and limitations must be improved

Author Response

Dear Authors, 

Thanks for the opportunity to review your paper titled "Quality of life following dental rehabilitation with customized subperiosteal implants: Α cohort study" and I appreciate the effort you've put into your research.

The  aim of this study was to assesses oral health-related quality of life in patients with subperiosteal implants

My concerns:

 

Comment 1: The introduction should be improved according to the recent publication

 

Response 1: We thank the reviewer for this helpful comment. The Introduction has been revised accordingly to better reflect the current literature on customized subperiosteal implants. In addition, the Discussion section was also updated to incorporate and discuss the most recent relevant publications on the topic, in order to better contextualize our findings within the contemporary evidence base (Introduction, Lines 79-86; Discussion 304-323).

 

Comment 2: A comprehensive and thorough explanation of these implants is required

 

Response 2: We thank the reviewer for this valuable comment. The Introduction has been revised accordingly by adding a concise explanatory description of customized subperiosteal implants, including their anatomical position, structural characteristics, and the role of digital planning and CAD/CAM manufacturing in their contemporary design and clinical application (Introduction, Lines 79-86)

 

Comment 3: Methods and materials: no sample size was performed

 

Response 3: Thank you for this comment. This point has already been mentioned in the manuscript. Specifically, in Section 2.6 (Study Size) we state that “The study size was determined by the number of eligible patients treated within the predefined recruitment period. Given the nature of the study, no formal sample size calculation was performed.”  In addition, in Section 2.7 (Statistical analysis) we already note the implications of the limited sample by stating that “Given the small sample size…” non-parametric methods were used, that analyses of floor and ceiling effects were exploratory because of the “limited sample size,” and that results were interpreted cautiously due to the “exploratory design and small cohort size.” In addition, the Discussion/Conclusion, we already acknowledge that the findings should be interpreted with caution because of the small sample size and limited generalizability. Finally, to make this clearer throughout the manuscript, we revised the title and the relevant text to explicitly identify the present work as a pilot study, which is consistent with the absence of a formal sample size calculation and the exploratory nature of the analyses (Title, Line 3; Abstract, Line 38; Discussion, Line 360).

 

Comment 4: the outcomes are of limited significance

 

Response 4: Thank you for this important comment. We agree that the significance of the outcomes is limited by the very small sample size, observational design, and short follow-up period. However, because there are still relatively few studies on this topic, we believe that these preliminary findings may contribute useful early evidence. Accordingly, we have revised the manuscript to emphasize that the results should be interpreted cautiously and considered hypothesis-generating rather than conclusive (Discussion, Lines 373-378).

 

Comment 5: The results are clearly reported

 

Response 5: Thank you for your comment.

 

Comment 6: The discussion should be improved in accordance with other articles on the topic

 

Response 6: We thank the reviewer for this constructive comment. The Discussion section has been revised accordingly and further strengthened through integration of additional relevant literature on customized subperiosteal implants and related treatment alternatives. In particular, we expanded the discussion to better contextualize our findings in relation to previously published studies, with emphasis on clinical indications, patient selection, treatment planning, and comparative considerations with other rehabilitation options for severe jaw atrophy (Discussion, Lines 304-323).

 

Comment 7: The strength and limitations must be improved

 

Response 7: Thank you for your comment. The Strenghts and Limitation section have been revised accordingly (Discussion, Lines 373-378, 396-399).

Reviewer 2 Report

Comments and Suggestions for Authors

This study addresses a clinically relevant topic with a novel approach, demonstrating promising short-term improvements in patient-reported outcomes. However, the extremely small sample size (n=9), single-center design, lack of a control group, and short follow-up period fundamentally limit the validity and generalizability of the conclusions. While the methods are generally sound for the scale of the study, these limitations necessitate a substantial revision to temper the claims and more clearly position the work as preliminary/hypothesis-generating.

The study is based on a very small sample size (N=9), which critically limits statistical power, the generalizability of findings, and the ability to detect clinically meaningful effects or conduct subgroup analyses. Acknowledge more forcefully that the current results are highly preliminary and hypothesis-generating rather than conclusive. Explicitly state that the study serves as a pilot or feasibility study.

The study design is a single-arm cohort study without a control group, making it impossible to attribute observed improvements solely to the intervention. Reframe the conclusions to reflect the observational nature and the inability to establish causality. Emphasize that future studies should incorporate comparative designs.

The study assesses outcomes only at 12 months post-surgery, which is a relatively short period for evaluating the long-term success, stability, and complication rates of dental implants. Complications such as peri-implantitis or eventual implant failure often manifest beyond the first year. This limits the clinical utility and predictive value of the study. Explicitly state in the Abstract and Conclusion that the findings are "short-term" and underscore the necessity for long-term follow-up studies.

The manuscript reports floor and ceiling effects but states "no formal hypothesis testing was applied to floor and ceiling effects," yet then presents them as "observed." Clarify the descriptive nature of these observations. Rephrase to avoid implying a statistically confirmed observation.

Significantly temper claims, emphasizing the preliminary nature of findings due to the very small sample size and observational design.

Author Response

Comment 1: This study addresses a clinically relevant topic with a novel approach, demonstrating promising short-term improvements in patient-reported outcomes. However, the extremely small sample size (n=9), single-center design, lack of a control group, and short follow-up period fundamentally limit the validity and generalizability of the conclusions. While the methods are generally sound for the scale of the study, these limitations necessitate a substantial revision to temper the claims and more clearly position the work as preliminary/hypothesis-generating.

 

Response 1: We thank the reviewer for this important comment. In response, we have revised the manuscript throughout to more appropriately reflect the preliminary nature of the study and to temper the interpretation of the findings. Specifically, relevant amendments have been made across the Title, Abstract, Discussion, and Conclusion to clearly acknowledge the very small sample size, the single-center design, the absence of a control group, and the relatively short follow-up period as important limitations affecting the validity and generalizability of the results. Overall, the manuscript has been updated throughout to ensure that the claims are fully aligned with the exploratory scope of the study (Title, Line 3; Abstract, Line 38; Discussion, Line 360)

 

Comment 2: The study is based on a very small sample size (N=9), which critically limits statistical power, the generalizability of findings, and the ability to detect clinically meaningful effects or conduct subgroup analyses. Acknowledge more forcefully that the current results are highly preliminary and hypothesis-generating rather than conclusive. Explicitly state that the study serves as a pilot or feasibility study.

 

Response 2: Thank you for your comment. We have revised the limitation section accordingly (Discussion, Lines 373-378).

 

Comment 3: The study design is a single-arm cohort study without a control group, making it impossible to attribute observed improvements solely to the intervention. Reframe the conclusions to reflect the observational nature and the inability to establish causality. Emphasize that future studies should incorporate comparative designs.

 

Response 3: We thank the reviewer for this important comment. We carefully reviewed the entire manuscript and revised the wording in the relevant sections to avoid any phrasing that could confuse readers or imply overinterpretation of the findings. We would like to clarify that we did not intend to claim causality, as this is an observational single-arm cohort study. Accordingly, the language was refined to better reflect the descriptive and observational nature of the study (Abstract, Lines 38-39; Discussion, Line 358).

 

Comment 4: The study assesses outcomes only at 12 months post-surgery, which is a relatively short period for evaluating the long-term success, stability, and complication rates of dental implants. Complications such as peri-implantitis or eventual implant failure often manifest beyond the first year. This limits the clinical utility and predictive value of the study. Explicitly state in the Abstract and Conclusion that the findings are "short-term" and underscore the necessity for long-term follow-up studies.

 

Response 4: Thank you for this important comment. We have revised the Abstract to explicitly describe the findings as short-term and to highlight the need for long-term follow-up studies (Abstract, Lines 38-39). We would also like to note that this issue is already acknowledged in the Conclusion, where the findings are referred to as short-term clinical outcomes (Conclusion, Line 405).

 

Comment 5: The manuscript reports floor and ceiling effects but states "no formal hypothesis testing was applied to floor and ceiling effects," yet then presents them as "observed." Clarify the descriptive nature of these observations. Rephrase to avoid implying a statistically confirmed observation.

 

Response 5: We thank the reviewer for this helpful comment. To clarify this, we revised the wording in the Results section (Lines, 272-274) to report these findings as descriptive proportions rather than as statistically confirmed effects. We also revised the Discussion section (Lines 396-399) to clarify that the postoperative clustering of scores suggests possible scale saturation and should be interpreted descriptively.

 

Commnet 6: Significantly temper claims, emphasizing the preliminary nature of findings due to the very small sample size and observational design.

 

Response 6: We thank the reviewer for this important comment. We agree that, given the very small sample size and observational design, the findings should be presented more cautiously. Accordingly, we tempered the wording to better emphasize the preliminary nature of the results. Specifically, we revised the Title (Line 3), Abstract (Lines 38–42) and the Discussion (Lines 360) to avoid overstating the strength of the evidence and to clarify that the findings should be interpreted cautiously.

Reviewer 3 Report

Comments and Suggestions for Authors

First of all I want to congratulate the authors regarding the scientific work! This manuscript presents a cohort study evaluating oral health-related quality of life (OHRQoL) and patient satisfaction following rehabilitation with customized subperiosteal implants in patients with severe alveolar atrophy. The authors report significant improvements in OHIP-14 scores and patient satisfaction (NRS) at 12 months postoperatively, with minimal complications and stable implant outcomes.

The topic is clinically relevant and timely, particularly given the renewed interest in patient-specific subperiosteal implants enabled by digital planning and CAD/CAM technologies. The use of validated patient-reported outcome measures (PROMs) represents a strength, and the manuscript aligns with current trends emphasizing patient-centered outcomes in oral and maxillofacial surgery.

However, the study is limited by a very small sample size (n = 9), lack of a control group, and short follow-up period. I have a few recommendations in order to improve the manuscript:

-in the title, please add PILOT STUDY

-keywords must be MeSH registered

-in the introduction section please strengthen the research gap statement

-the number of the patients included in the study significantly limits statistical power and generalizability. Although the authors state that no formal sample size calculation was performed, a justification of sample size or discussion of feasibility constraints should be included. Please expand the limitations section regarding statistical power and external validity.

-while improvements in PROMs are clearly demonstrated, the manuscript would benefit from a more detailed explanation of clinical decision-making criteria for selecting subperiosteal implants.

-please make comparison with alternative treatment options (e.g., zygomatic implants, bone grafting) on the discussion section, focused on nndications and contraindications, patient selection criteria, comparative advantages / disadvantages

-some aspects require further detail: please clarify whether the study is prospective or retrospective (currently somewhat ambiguous)

-provide more detail on calibration of evaluators and handling of potential measurement bias

-the statement “no participants were lost to follow-up” is positive but unusual in small cohorts—clarify follow-up compliance

-the implant placement must respect the anatomic landmarks. Please discuss and cite the following article https://www.mdpi.com/2077-0383/14/2/636

 

Author Response

Comment 1: First of all I want to congratulate the authors regarding the scientific work! This manuscript presents a cohort study evaluating oral health-related quality of life (OHRQoL) and patient satisfaction following rehabilitation with customized subperiosteal implants in patients with severe alveolar atrophy. The authors report significant improvements in OHIP-14 scores and patient satisfaction (NRS) at 12 months postoperatively, with minimal complications and stable implant outcomes.

The topic is clinically relevant and timely, particularly given the renewed interest in patient-specific subperiosteal implants enabled by digital planning and CAD/CAM technologies. The use of validated patient-reported outcome measures (PROMs) represents a strength, and the manuscript aligns with current trends emphasizing patient-centered outcomes in oral and maxillofacial surgery.

 

Response 1: We sincerely thank the reviewer for the positive and encouraging comments and for recognizing the clinical relevance and patient-centered focus of our study.

 

Comment 2: However, the study is limited by a very small sample size (n = 9), lack of a control group, and short follow-up period. I have a few recommendations in order to improve the manuscript:

-in the title, please add PILOT STUDY

 

Response 2: We thank the reviewer for this helpful comment. We agree that the very small sample size, lack of a control group, and short follow-up period are important limitations of the present study. In response to the reviewer’s suggestion, we have revised the title to identify the study as a pilot cohort study (Title, Line 3) and have further revised the Abstract and Discussion to emphasize the preliminary nature of the findings (Abstract, Line 38; Discussion, Line 360).

 

Comment 3: -keywords must be MeSH registered

 

Response 3: Thank you for this valuable suggestion. The keywords have been revised accordingly to ensure consistency with MeSH-registered terminology (Keywords, Lines 50-51).

 

Comment 4: -in the introduction section please strengthen the research gap statement

 

Response 4: Thank you for this helpful comment. The Introduction has been revised to strengthen the research gap statement by highlighting the limited available evidence on patient-reported outcomes, particularly oral health-related quality of life and patient satisfaction, following rehabilitation with customized subperiosteal implants in patients with severe alveolar atrophy (Introduction, Lines 109-114).

 

Comment 5: -the number of the patients included in the study significantly limits statistical power and generalizability. Although the authors state that no formal sample size calculation was performed, a justification of sample size or discussion of feasibility constraints should be included. Please expand the limitations section regarding statistical power and external validity.

 

Response 5: The limitation section has been revised accordingly (Discussion, Lines 373-378).

 

Comment 6: -while improvements in PROMs are clearly demonstrated, the manuscript would benefit from a more detailed explanation of clinical decision-making criteria for selecting subperiosteal implants.

 

Response 6: We thank the reviewer for this helpful comment. The Discussion section has been revised accordingly to provide a clearer explanation of the clinical decision-making process for selecting customized subperiosteal implants, with particular emphasis on indications, case selection, and the clinical situations in which this treatment option may be preferred over conventional alternatives (Discussion, Lines 304-323).

 

Comment 7: -please make comparison with alternative treatment options (e.g., zygomatic implants, bone grafting) on the discussion section, focused on nndications and contraindications, patient selection criteria, comparative advantages / disadvantages

 

Response 7: We thank the reviewer for this valuable suggestion. The Discussion section has been revised accordingly to include a comparison between customized subperiosteal implants and alternative treatment options, particularly zygomatic implants and bone grafting procedures, focusing on indications, contraindications, patient selection criteria, and their respective advantages and disadvantages (Discussion, Lines 304-323).

 

Comment 8: -some aspects require further detail: please clarify whether the study is prospective or retrospective (currently somewhat ambiguous)

 

Response 8: Thank you for this comment. We have clarified in the Materials and Methods section that this study was designed as a prospective cohort study (Materials and Methods, Line 125).

 

Comment 9: -provide more detail on calibration of evaluators and handling of potential measurement bias

 

Response 9: Thank you for this comment. We have revised the “Strategies to reduce bias” section to provide additional details on the standardized assessment procedures used to minimize potential measurement bias (Materials and Methods, Lines 193-196).

 

Comment 10: -the statement “no participants were lost to follow-up” is positive but unusual in small cohorts—clarify follow-up compliance

 

Response 10: Thank you for this comment. We have revised the manuscript to clarify follow-up compliance by specifying that all enrolled patients completed the 12-month follow-up and were included in the final analysis (Materials and Methods, Lines 161-162).

 

Comment 11: -the implant placement must respect the anatomic landmarks. Please discuss and cite the following article https://www.mdpi.com/2077-0383/14/2/636

 

Response 11: Thank you for this valuable suggestion. We agree that respect for anatomical landmarks is essential during implant placement. However, in the present study all customized subperiosteal implants were placed exclusively in the maxilla, whereas the suggested article focuses on variability of mandibular osseous landmarks and the mandibular foramen in relation to inferior alveolar nerve block. Therefore, we believe that this reference is not directly relevant to the anatomical context of our study and was not added to the revised manuscript.

Round 2

Reviewer 2 Report

Comments and Suggestions for Authors

This cohort study investigates the quality of life and patient satisfaction following dental rehabilitation with customized subperiosteal implants in nine adult patients with severe alveolar atrophy. The study employed validated questionnaires (OHIP-14, NRS) preoperatively and 12 months postoperatively, demonstrating significant improvements in both oral health-related quality of life and patient satisfaction, with a favorable short-term complication profile. 

Nevertheless, the small number of patients included in the study limits the generalizability of the findings, a limitation that is now noted in the manuscript.

In conclusion, the authors have revised and completed the manuscript in accordance with the recommendations.

 

Reviewer 3 Report

Comments and Suggestions for Authors

The manuscript has been improved and can be published!