Table 5.

Reporting checklist for studies evaluating direct and indirect restorations

Section and topic	Item no	Recommendations
Title	1	Indicate the type of study and important parameters (material, Black’s classification, primary or permanent teeth)
Abstract	2	Structured summary of study design, methods, results, and conclusions
Introduction		Introduce and justify
Background/rationale	3	Scientific and clinical background including the intended indication and clinical use of the restorative procedures and/or materials. Justify research needs
Objectives	4	Study objectives and hypotheses
Methods		Describe
Study design	5	Indicate the study design, e.g., randomized controlled clinical trial, clinical trial, case control study, case study, or epidemiological, observational, or diagnostic study, and if the study protocol was designed prospectively or retrospectively. Describe the study setting, e.g., university- or practice-based and the allocation of interventions, e.g., split-mouth or parallel-arm design. Report relevant dates, time intervals including periods of recruitment, and follow-ups
Sample size	6	Intended sample size and how it was determined (sample size calculation). Include typically no more than one restoration per study arm
Patients	7	Patient population, e.g., children, adolescents, adults, elderly, etc. In- and exclusion criteria for patients, procedures for screening, selection, and randomization. Where and when potentially eligible participants were identified (setting, location, and dates). Give the eligibility criteria, screening, and selection procedures. Report numbers of individuals in each stage of study, e.g., numbers potentially eligible, examined for eligibility, confirmed eligible, included in the study, completing follow-up, and analyzed. Give reasons for nonparticipation or drop-out in each stage
Teeth	8	Exclusion and inclusion criteria for tooth selection, cleaning, and processing prior to beginning of the study/placing restoration. Account for all teeth that were included, restored, and monitored. Report the number of included teeth separately for each type of restoration, e.g., according to Black’s classification, etc. Report indications or reasons for restoration, tooth type, number of restored surfaces, and tooth-related dental history, i.e., caries, endodontic treatment, or trauma
Restorative interventions and materials	9	Provide complete and detailed information about the clinical setting, workflow, instruments, and materials (product and batch number, manufacturer) for all restorative procedures. Indicate operator initials
Evaluation of restorations	10a	Provide complete and detailed information about the evaluation setting, workflow, illumination, cleaning, drying, instruments, and procedures for repeated diagnostic evaluation of all restorations. Indicate examiner initials
	10b	Define primary and secondary outcome parameters. Report and describe which categories of the FDI criteria set were selected and why and how they were used
	10c	Report and describe if additional clinical or laboratory evaluations were performed by which researcher, e.g., sensibility testing, intraoral photographs, 3D wear analysis on digital models, or scanning electron microscopy analysis of marginal adaptation on replica models, etc
Blinding	11	Indicate if operator(s), examiner(s), patients, and statistician(s) were blinded or if an independent evaluation procedure was included, e.g., on photographs
Training and calibration	12	Details of theoretical and practical training, training setting, and results from calibration for operators and examiners, e.g., Kappa values, should be given
Operators and examiners	13	Report the role and level of clinical and/or diagnostic (research) experience of each operator and examiner, e.g., years of relevant clinical experience. Visual acuity of both operators and examiners should be reported
Data handling and statistics	14	Describe all statistical methods for evaluating the longevity of restorations and its quality over time including descriptive data for each of the chosen categories. Explain how variables and missing data were handled in the analyses. Indicate the used statistical methods to analyze the survival probability, e.g., Kaplan–Meier statistics/curves, and to compare different groups, e.g., log-rank test, Wilcoxon signed rank test, Bonferroni corrections, multivariate analyses or Cox regression, or proportional hazards models
Results		Report
Study population and/or teeth	15	Flow of participants, using a diagram. Report numbers of the included patients and teeth in relation to test and control groups
Characterization of the study population	16	Characterize the study population (age, female/male ratio, dental health status, oral hygiene, etc.)
Outcome data	17a	Report adverse events and undesirable effects
	17b	Provide complete descriptive and explorative data of quality and longevity of tested restorations. Kaplan–Meier statistics/curves illustrate the cumulative survival probability over the study period
	17c	Present results from comparative analysis
Discussion		Discuss
Study population	18	Conclude whether the study population is representative for the target group. Furthermore, include a statement if the study sample met the requirements from the sample size calculation. Evaluate dropout and attrition rates
Data interpretation	19	Summarize the important findings from the study and interpret the data in relation to the recently published literature. Consider potential methodological differences between studies and its influence on the comparability. Furthermore, discuss the (clinical) relevance of the study results and the potential implications for dental practice. Compare the results with those of similar clinical studies and assess deviations if present
Strength and limitation	20	Consider methodological strengths and limitations of the used study design. Report potential sources of bias, statistical uncertainty, and lacking generalizability. Discuss both direction and magnitude of any potential bias
Conclusion	21	Draw a well-balanced and unbiased study conclusion
Other information		If applicable
Ethics	22	Indicate the ethical committee/institutional review board and trial registration number
Funding	23	Mention sources of funding and other support. Explain the role of funders
Conflict of interest	24	Summarize potential conflicts of interest for each of the authors