When planning, conducting, and disseminating dental research, it is crucial to adhere to comprehensive ethical and scientific standards to ensure subject protection, data reliability, and meaningful contribution to knowledge.
Sources
Emanuel, E.J., Wendler, D., Grady, C., 2000. What makes clinical research ethical? JAMA 283, 2701–2711.
Resneck, J.S., Jr, 2024. - Revisions to the Declaration of Helsinki on Its 60th Anniversary: A Modernized Set of Ethical Principles to Promote and Ensure Respect for Participants in a Rapidly Innovating Medical Research Ecosystem. JAMA. 2025 Jan 7;333(1):15-17. doi: 10.1001/jama.2024.21902 -
Schwendicke F, Uribe SE, Jakubovics NS.. The Science System at the Limit: A Call to Action for Considerate Publishing J Dent Res. 2025. 10.1177/00220345251349804
You must have an in-depth understanding of the subject. This means you are familiar with the authors, institutions, hypotheses, methods, and results already available in the literature. After reading the literature extensively and exhaustively, you identified a timely, relevant, and important gap in the knowledge that requires new research.
Phase 1: Planning and Design of Dental Research
This phase focuses on ensuring the foundational ethical and scientific integrity of the study.
1.1 Establish Ethical and Scientific Justification (The "Seven Requirements" of Emanuel et al. ):
Value:
Define a clear research question that will lead to "enhancements of health or knowledge" or "increase understanding of human biology" [Emanuel et al., 4].
Avoid trivial hypotheses or research that substantially overlaps with proven results [Emanuel et al., 14].
Ensure the results are likely to be disseminated and, if applicable, the intervention could be practically implemented [Emanuel et al., 14]. This justifies exposing subjects to risk and ensures responsible use of resources [Emanuel et al., 15].
Scientific Validity:
Design a methodologically rigorous study [Emanuel et al., 4, 21]. This includes having a clear scientific objective, using accepted principles and methods, and ensuring sufficient statistical power to test the objective definitively [Emanuel et al., 22].
Develop a plausible data analysis plan [Emanuel et al., 22].
If comparing therapies, ensure "clinical equipoise" (an honest null hypothesis) exists, meaning there is genuine uncertainty within the scientific community about which intervention is better [Emanuel et al., 23]. Invalid research, due to poor design, wastes resources and is unethical [Emanuel et al., 24].
Fair Subject Selection:
Determine inclusion and exclusion criteria based solely on scientific goals, not on vulnerability or privilege [Emanuel et al., 4, 25].
Ensure that groups who bear the risks are also in a position to enjoy the benefits of the research results [Emanuel et al., 29].
Include women, minorities, and children in the research where scientifically appropriate to maximise the study's benefits and value, ensuring generalisability of results [Emanuel et al., 26, 28].
Favourable Risk-Benefit Ratio:
Minimise potential risks to individual subjects within the context of good clinical practice [Emanuel et al., 4, 31, 32].
Enhance potential benefits to individual subjects; only health-related benefits directly from the research should be considered [Emanuel et al., 32, 33].
Ensure potential benefits to individuals and society outweigh the risks [Emanuel et al., 4, 31]. Do not consider extraneous benefits like payment when assessing this ratio [Emanuel et al., 33].
Independent Review:
Submit the research protocol for review by an ethics committee [Resneck, 91]. This committee should consist of individuals unaffiliated with the research, possessing diverse expertise (scientific, statistical, ethical, legal, and lay knowledge), to minimise conflicts of interest and ensure public accountability [Emanuel et al., 4, 38, 52; Resneck, 121, 122, 123].
Ensure the review encompasses both scientific and ethical aspects [Resneck, 91].
1.2 Regulatory Compliance and Documentation (EU Regulation No 536/2014 Focus):
Prepare a comprehensive application dossier including the detailed protocol [Resneck, 172, 173, 310].
Detail the objectives, design, methodology, statistical considerations, purpose, and organisation of the clinical trial in the protocol [Resneck, 310].
Specify compliance with EU Regulation and Good Clinical Practice (GCP) [Resneck, 311].
Include justification for involving specific populations (e.g., minors, incapacitated subjects, pregnant or breastfeeding women) if applicable, detailing how their specific needs and protections will be addressed [Resneck, 123, 124, 314, 320]. The trial must be essential for these groups or relate directly to their condition [Resneck, 195, 196, 199, 200, 202, 203].
Justify the gender and age allocation of subjects and explain any exclusions or underrepresentation [Resneck, 320].
Develop detailed recruitment and informed consent procedures [Resneck, 320, 348, 349, 350].
Outline arrangements for subject care after participation, if differing from normal care [Resneck, 321].
Describe the publication policy [Resneck, 323].
Confirm suitability of investigators (qualified, experienced in patient care) and clinical trial sites (adequate facilities, equipment, human resources) [Resneck, 236, 237, 351, 352].
Ensure systems for damage compensation are in place (e.g., insurance, guarantee) [Resneck, 266, 267, 353].
Plan for secure data handling and protection in accordance with data protection laws, including organisational and technical measures to prevent unauthorised access or loss [Resneck, 243, 323].
Prepare labelling for investigational and auxiliary medicinal products according to specified information requirements to ensure safety and data reliability [Resneck, 257, 258, 259, 261, 380-391].
Phase 2: Conducting the Research
This phase involves the execution of the study, with a strong emphasis on subject protection and data integrity.
2.1. Obtain Informed Consent:
Provide accurate, comprehensive, concise, clear, and understandable information to subjects or their legally designated representatives in a prior interview with a qualified team member [Emanuel et al., 40; Resneck, 185, 186].
Verify the subject's understanding of the information [Resneck, 188].
Ensure consent is written, dated, and signed, providing a copy to the subject/representative. If unable to write, use appropriate alternative means with an impartial witness [Resneck, 184].
Allow adequate time for the subject or representative to consider their decision [Resneck, 184].
For incapacitated subjects, obtain consent from their legally designated representative, ensuring information is adapted to the subject's understanding and their explicit wish to refuse/withdraw is respected [Resneck, 194, 195].
For minors, obtain consent from their legally designated representative and provide information adapted to their age and mental maturity. Respect their explicit wish to refuse or withdraw [Resneck, 198]. If they reach legal age during the trial, obtain their express informed consent to continue [Resneck, 201].
In emergency situations, obtain consent and information after the initial intervention only if strict conditions are met (e.g., unable to give prior consent, direct benefit expected, no prior objections, minimal risk) and seek subsequent informed consent without undue delay [Resneck, 205, 206, 207, 208, 209].
For cluster trials, if simplified consent is permitted, ensure the required information is given and the subject does not object. Document all refusals and withdrawals [Resneck, 191, 192, 193].
Ensure no undue influence (including financial) is exerted on subjects [Resneck, 181]. Compensation should only cover expenses and loss of earnings [Resneck, 195, 199, 204].
2.2 Maintain Subject Welfare and Data Integrity:
Continuously monitor the well-being of enrolled subjects [Emanuel et al., 44, 45].
Provide appropriate treatment for adverse reactions and, if necessary, remove subjects from the study [Emanuel et al., 44].
Protect subjects' privacy and confidentiality by managing information in accordance with applicable data protection laws [Emanuel et al., 44; Resneck, 180, 243].
Inform subjects of newly discovered risks or benefits related to the intervention or their clinical condition [Emanuel et al., 44].
Respect subjects' right to withdraw from the research at any time without penalty or having to provide justification [Emanuel et al., 44; Resneck, 183]. Note that withdrawal does not invalidate data collected before the revocation of consent [Resneck, 183].
Ensure adequate monitoring of the clinical trial by the sponsor to verify subject rights, safety, well-being, and data reliability/robustness [Resneck, 235].
Report all serious breaches of the regulation or protocol affecting subject safety/rights or data reliability without undue delay (within 7 days) [Resneck, 239, 240].
Take urgent safety measures if an unexpected event seriously affects the benefit-risk balance, notifying Member States without undue delay (within 7 days) [Resneck, 241, 242].
Report adverse events and suspected unexpected serious adverse reactions (SUSARs) to the sponsor and the relevant authorities (e.g., EU database) within specified timelines [Resneck, 222, 224, 227, 228].
Maintain a clinical trial master file containing essential documents for verification of conduct and data quality, ensuring it is readily available for inspection and archived for at least 25 years [Resneck, 244, 245].
Phase 3: Disseminating the Research
This phase focuses on responsible sharing of findings and contributing to the scientific community.
3.1 Ensure Transparency and Open Science:
Submit a summary of the clinical trial results to the EU database within one year of the trial's end, regardless of the outcome. This must include a summary understandable to laypersons [Resneck, 214].
Inform subjects of what was learned from the research to acknowledge their contribution [Emanuel et al., 44].
Preregister studies and deposit raw data to enhance transparency and reproducibility [Schwendicke et al., 404].
Adhere strictly to reporting guidelines for all publications [Schwendicke et al., 404].
Consider publishing peer review comments (open peer review) for greater accountability [Schwendicke et al., 404].
3.2 Responsible Publication:
Prioritise quality over quantity in publications [Schwendicke et al., 399, 404]. Focus on meaningful contributions rather than excessive or redundant publishing [Schwendicke et al., 402, 404].
Remain vigilant in identifying and avoiding predatory journals [Schwendicke et al., 400, 402, 405].
Carefully evaluate journals by consulting experienced mentors, colleagues, or librarians, and use reputable resources (e.g., World Association of Medical Editors’ guidelines, ThinkCheckSubmit.org, NIH recommendations) [Schwendicke et al., 406].
Verify email addresses, URLs, and other details associated with communications from journals [Schwendicke et al., 406].
If publishing a systematic review, assess and exclude low-quality studies to prevent their inadvertent acquisition of high-quality evidence status [Schwendicke et al., 401].
Advocate for stricter enforcement of ethical publishing standards [Schwendicke et al., 406].
Read here: Recommended format for a 'research protocol'
Clinical Trial Registration Form here
Plan your Data Management Plan (DMP) Template here or create in ARGOS. More information here.
For the protocol, consider all the items according to your research question and study design, as
Randomised controlled trials (RCTs): CONSORT guidelines, flowchart and structured abstract checklist
Systematic reviews and meta-analyses: PRISMA guidelines, flowchart and structured abstract checklist
Observational studies in epidemiology: STROBE guidelines (also refer to RECORD for observational studies using routinely collected health data) and MOOSE guidelines
If you are unsure which guidelines are the most relevant for your type of study, please use the online tool developed by the EQUATOR Network.
1.2. Obtain the ethical approval of your IRB
1.3 Publish your protocol:
or elsewhere as Trials
Ideally, it would be best to decide which journal to submit to before you start writing the final report to ensure you follow the specific journal's instructions.
There are three ways, in order of preference.
In the best case, your research question started with a question raised by previous research. In this case, you should opt for the same journal where the question was raised and indicate to the editor that your research aims to address the question raised in the article published in their journal.
If you are raising a problem from multiple previous research, then you should see which journal is the most cited in your references and choose that one.
if you are still in doubt, you can use an online tool.
However, be careful not to fall for predatory journal offers, which invite you to publish for a fee. Follow the guidelines at Think-Check-Submit
First, start with the objective or research question and then write the material and methods in detail. If you already have a good protocol published, the methods and introduction section should be ready. The start the descriptive analysis of the results, read here.
Then, perform the explanatory/hypothesis analysis and select a figure or table that summarises the main result or answer to the question.
With this table or figure in mind, write the result, the discussion, and the introduction. (You can modify the introduction from the Protocol)
With all this, you can write the abstract and, finally, the title.
In summary
Material and methods (almost complete in the Protocol)
Results
Discussion
Introduction (almost complete in the Protocol)
Summary
Title
I recommend writing in the following order:
Since you should have identified the appropriate design for the study question, you should write this section following any guidelines available on Equator-network according to the specific design.
The most common questions and designs are:
Randomised controlled trials (RCTs): CONSORT guidelines, flowchart and structured abstract checklist
Systematic reviews and meta-analyses: PRISMA guidelines, flowchart and structured abstract checklist
Observational studies in epidemiology: STROBE guidelines (also refer to RECORD for observational studies using routinely collected health data) and MOOSE guidelines
Diagnostic accuracy studies: STARD guidelines
Quality improvement studies: SQUIRE guidelines
Multivariate prediction models: TRIPOD guidelines
Economic evaluation studies: CHEERS guidelines
Animal pre-clinical studies: ARRIVE guidelines
Web-based surveys: CHERRIES guidelines
Studies using data from electronic health records: CODE-EHR guidelines
Artificial intelligence in Dentistry: Artificial intelligence in dental research: Checklist for authors, reviewers, readers
If you are unsure which guidelines are the most relevant for your type of study, please use the online tool developed by the EQUATOR Network.
In practice, this is where you start writing your article. After analysing the data, you get a figure representing the result and with that figure in mind, you structure the whole text.
When formulating the results section, it's important to remember that the results of a study do not prove anything. Research results can only confirm or reject the research problem underpinning your study. However, the act of articulating the results helps you to understand the problem from within, to break it into pieces, and to view the research problem from various perspectives.
The page length of this section is set by the amount and types of data to be reported. Be concise, using non-textual elements, such as figures and tables, if appropriate, to present results more effectively. In deciding what data to describe in your results section, you must clearly distinguish material that would normally be included in a research paper from any raw data or other material that could be included as an appendix. In general, raw data should not be included in the main text of your paper unless requested to do so by your professor.
Avoid providing data that is not critical to answering the research question. The background information you described in the introduction section should provide the reader with any additional context or explanation needed to understand the results. A good rule is to always re-read the background section of your paper after you have written up your results to ensure that the reader has enough context to understand the results [and, later, how you interpreted the results in the discussion section of your paper].
In general, the content of your results section should include the following elements:
An introductory context for understanding the results by restating the research problem that underpins the purpose of your study.
A summary of your key findings arranged in a logical sequence that generally follows your methodology section.
Inclusion of non-textual elements, such as, figures, charts, photos, maps, tables, etc. to further illustrate the findings, if appropriate.
In the text, a systematic description of your results, highlighting for the reader observations that are most relevant to the topic under investigation [remember that not all results that emerge from the methodology that you used to gather the data may be relevant].
Use of the past tense when refering to your results.
The page length of your results section is guided by the amount and types of data to be reported. However, focus only on findings that are important and related to addressing the research problem.
Using Non-textual Elements
Either place figures, tables, charts, etc. within the text of the result, or include them in the back of the report--do one or the other but never do both.
In the text, refer to each non-textual element in numbered order [e.g., Table 1, Table 2; Chart 1, Chart 2; Map 1, Map 2].
If you place non-textual elements at the end of the report, make sure they are clearly distinguished from any attached appendix materials, such as raw data.
Regardless of placement, each non-textual element must be numbered consecutively and complete with caption [caption goes under the figure, table, chart, etc.]
Each non-textual element must be titled, numbered consecutively, and complete with a heading [title with description goes above the figure, table, chart, etc.].
In proofreading your results section, be sure that each non-textual element is sufficiently complete so that it could stand on its own, separate from the text.
When writing the results section, avoid doing the following:
Discussing or interpreting your results. Save all this for the next section of your paper, although where appropriate, you should compare or contrast specific results to those found in other studies [e.g., "Similar to Smith [1990], one of the findings of this study is the strong correlation between motivation and academic achievement...."].
Reporting background information or attempting to explain your findings; this should have been done in your Introduction section, but don't panic! Often the results of a study point to the need to provide additional background information or to explain the topic further, so don't think you did something wrong. Revise your introduction as needed.
Ignoring negative results. If some of your results fail to support your hypothesis, do not ignore them. Document them, then state in your discussion section why you believe a negative result emerged from your study. Note that negative results, and how you handle them, often provides you with the opportunity to write a more engaging discussion section, therefore, don't be afraid to highlight them.
Including raw data or intermediate calculations. Ask your professor if you need to include any raw data generated by your study, such as transcripts from interviews or data files. If raw data is to be included, place it in an appendix or set of appendices that are referred to in the text.
Be as factual and concise as possible in reporting your findings. Do not use phrases that are vague or non-specific, such as, "appeared to be greater or lesser than..." or "demonstrates promising trends that...."
Presenting the same data or repeating the same information more than once. If you feel the need to highlight something, you will have a chance to do that in the discussion section.
Figures and tables: Vickers AJ, Assel MJ, Sjoberg DD, Qin R, Zhao Z, Koyama T, et al. Guidelines for Reporting of Figures and Tables for Clinical Research in Urology. Eur Urol. 2020. https://doi.org/10.1016/j.eururo.2020.04.048.
Statistics:
Assel M, Sjoberg D, Elders A, Wang X, Huo D, Botchway A, et al. Guidelines for reporting of statistics for clinical research in urology. BJU Int. 2019;123:401–10.
what is the main result, and what does it mean
what are the advantages and limitations of the design used and their impact on the interpretation of the results
comparison with other studies, with an emphasis on the methodologies used
what these results mean for the clinic
what remains to be known and future studies
More information PLOS
Identify what the problem is
Quantifies its magnitude: prevalence, incidence, severity, and vulnerability.
Describes what is known about the problem, with emphasis on the methodologies used
Describes what is not known, and why it is important to know this information.
State the objective of this research