Abstract
Background With the introduction of the new dental licensing regulations (ZApprO) in Germany, preclinical teaching time was substantially reduced, particularly affecting practical training. To support students’ learning under these conditions, a formative Objective Structured Clinical Examination (OSCE) was implemented early in the preclinical curriculum. This study aimed to evaluate the impact of an early formative OSCE on undergraduate dental students’ learning behavior, self-assessment, and exam preparation.
Methods A total of 71 undergraduate dental students (mean age 22 years) participated voluntarily in a formative OSCE in preventive dentistry during the summer semester 2022 and winter semester 2022/23. Students were randomly assigned to an intervention group (OSCE halfway through the semester) or a control group (OSCE shortly before the final exam). The OSCE included five stations developed according to the National Competence-Based Learning Objectives Catalog for Dentistry. Students completed pseudonymized questionnaires at two time points (T0: after OSCE; T1: after the final exam). The questionnaire assessed learning behavior (including strategies for dealing with difficult material and use of additional resources), self-assessment (perceived learning status and exam readiness), motivation, and exam preparation. Statistical analyses were performed using Mann–Whitney U and Wilcoxon tests.
Results Participation in the formative OSCE enabled students to better evaluate their learning status and identify individual learning needs for the final exam. Although both groups started exam preparation at similar times (T0: p=0.422; T1: p=0.674), the intervention group reported higher initial motivation and greater awareness of knowledge gaps after the OSCE. Differences were also observed in how students dealt with difficult material and in their use of supplementary learning resources.
Conclusions An early formative OSCE fosters undergraduate dental students’ self-assessment, reflection on learning behavior, and awareness of learning needs, thereby supporting more targeted exam preparation. However, it does not necessarily lead to an earlier start of study activities. Implementing formative OSCEs in the middle of the semester, accompanied by structured feedback, may further enhance their educational impact.
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Article
ERCT Criteria Breakdown
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Level 1 Criteria
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C
Class-level RCT
- Randomization was at the individual student level (within one course cohort), not at the class or school level, and no tutoring exception applies.
- "Students were randomly assigned to two groups." (p. 2 of 8)
Relevant Quotes:
1) "Students were randomly assigned to an intervention group (OSCE halfway through the semester) or a control group (OSCE shortly before the final exam)." (p. 1 of 8)
2) "Students were randomly assigned to two groups." (p. 2 of 8)
3) "The preventive dentistry lecture series in the second preclinical semester at Johannes Gutenberg University Mainz served as the study setting." (p. 2 of 8)
Detailed Analysis:
ERCT criterion C requires randomization at the class level (or stronger, e.g., school-level) to reduce contamination across students who share instruction and social learning environments.
The paper describes a single course setting (one lecture series at one university) and states that students were randomized to two timing conditions. There is no indication that intact classes, course sections, or schools were randomized.
The tutoring/personal-teaching exception does not apply because the intervention is not one-to-one tutoring; it is a change in the timing of a formative OSCE within a cohort.
Final: Criterion C is not met because randomization occurred at the individual student level, not the class (or school) level.
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E
Exam-based Assessment
- Outcomes were measured via self-report questionnaires (and the OSCE was ungraded with no recorded scores), not via standardized exam-based assessment outcomes.
- "Data were collected using two structured, pseudonymized questionnaires administered at two time points (T0: directly after the OSCE; T1: after the final exam)." (p. 2 of 8)
Relevant Quotes:
1) "Students completed pseudonymized questionnaires at two time points (T0: after OSCE; T1: after the final exam)." (p. 1 of 8)
2) "Data were collected using two structured, pseudonymized questionnaires administered at two time points (T0: directly after the OSCE; T1: after the final exam)." (p. 2 of 8)
3) "Items on learning strategies were based on the validated LIST questionnaire [6], while items on exam preparation, motivation, and perceived learning status were developed specifically for this study and pretested for clarity." (p. 2 of 8)
4) "As the OSCE was implemented as a formative, ungraded assessment, no performance scores were recorded for analytical purposes, and students did not receive individual results. Therefore, no correlation with final exam grades was possible." (p. 2 of 8)
Detailed Analysis:
ERCT criterion E requires that the study uses standardized, exam-based assessments as outcome measures (i.e., objective exam outcomes, not bespoke/self-report instruments).
Here, the outcomes are collected using questionnaires (including study-specific items), and the OSCE is explicitly ungraded with no recorded performance scores used in analysis. The paper does not report standardized exam score outcomes as the study endpoints.
Final: Criterion E is not met because the measured outcomes are questionnaire-based and OSCE performance outcomes were not recorded/analyzed as standardized exam results.
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T
Term Duration
- The intervention-to-outcome interval is within the same semester (week 7 OSCE vs week 12 final exam), which is shorter than a full academic term follow-up from intervention onset.
- "The intervention group (IG) completed a formative OSCE halfway through the semester (week 7), while the control group (CG) completed the OSCE in week 11, shortly before the final exam in preventive dentistry (week 12)." (p. 2 of 8)
Relevant Quotes:
1) "The intervention group (IG) completed a formative OSCE halfway through the semester (week 7), while the control group (CG) completed the OSCE in week 11, shortly before the final exam in preventive dentistry (week 12)." (p. 2 of 8)
2) "Data were collected using two structured, pseudonymized questionnaires administered at two time points (T0: directly after the OSCE; T1: after the final exam)." (p. 2 of 8)
Detailed Analysis:
ERCT criterion T requires that outcomes are measured at least one full academic term after the intervention begins (typically about 3-4 months).
In this study, the experimental manipulation is the timing of the OSCE. For the intervention group, the OSCE occurs in week 7 and the later measurement point is after the final exam in week 12. This implies roughly five weeks between the intervention (early OSCE) and the later outcome measurement.
The paper does not document a term-length follow-up window from the intervention timing to outcome measurement; rather, all measurements occur within the same semester shortly after the OSCE.
Final: Criterion T is not met because the documented follow-up after the intervention is shorter than one academic term.
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D
Documented Control Group
- The control condition is described, but the paper does not provide clearly reported control-group baseline characteristics and/or baseline performance separately by group.
- "A total of 71 dental students participated voluntarily: 32 in summer semester 2022 and 39 in winter semester 2022/23. The average age was 22 years (range 19-28); 18 were male and 53 female." (p. 2 of 8)
Relevant Quotes:
1) "Students were randomly assigned to two groups." (p. 2 of 8)
2) "The intervention group (IG) completed a formative OSCE halfway through the semester (week 7), while the control group (CG) completed the OSCE in week 11, shortly before the final exam in preventive dentistry (week 12)." (p. 2 of 8)
3) "A total of 71 dental students participated voluntarily: 32 in summer semester 2022 and 39 in winter semester 2022/23. The average age was 22 years (range 19-28); 18 were male and 53 female." (p. 2 of 8)
4) "Data were collected using two structured, pseudonymized questionnaires administered at two time points (T0: directly after the OSCE; T1: after the final exam)." (p. 2 of 8)
Detailed Analysis:
ERCT criterion D requires a well-documented control group, which includes (at minimum) clear group-specific characteristics and baseline performance/baseline outcome measures that allow readers to assess comparability of control vs intervention.
The paper defines the control condition (OSCE in week 11) and provides overall sample demographics. However, it does not provide clearly stated baseline characteristics separately for control vs intervention.
Additionally, the first measurement point is "directly after the OSCE" (T0), which is not a pre-intervention baseline for either group, because each group completes the OSCE at a different time.
Final: Criterion D is not met because the control group is not documented with clearly reported group-specific baseline data.
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Level 2 Criteria
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S
School-level RCT
- The study randomized individual students within one university course, not multiple schools (or equivalent institutions/sites).
- "The preventive dentistry lecture series in the second preclinical semester at Johannes Gutenberg University Mainz served as the study setting." (p. 2 of 8)
Relevant Quotes:
1) "The preventive dentistry lecture series in the second preclinical semester at Johannes Gutenberg University Mainz served as the study setting." (p. 2 of 8)
2) "Students were randomly assigned to two groups." (p. 2 of 8)
Detailed Analysis:
ERCT criterion S requires randomization at the school/site level (i.e., among multiple institutions or implementation sites).
The paper reports a single setting (one lecture series at one university) and student-level random assignment to two groups. There is no evidence of multiple schools/sites being randomized.
Final: Criterion S is not met because randomization was not at the school (site) level.
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I
Independent Conduct
- The paper does not report an independent external evaluation team; core study roles were performed by the author group.
- "Conceptualization, A.H., T.J.P.-G. and F.B.; Methodology, A.H. and L.Z.; Validation, A.H; Resources, A.H.; Data curation, A.H.; Writing-original draft, T.J.P.-G.; Supervision, J.D.; Project administration, J.D." (p. 8 of 8)
Relevant Quotes:
1) "The stations were developed according to the National Competence-Based Learning Objectives Catalog for Dentistry (NKLZ) and a standardized blueprint provided by the Rudolf Frey Learning Clinic." (p. 2 of 8)
2) "We would also like to thank Irene Schmidtmann and her colleagues at the Institute for Medical Biometry, Epidemiology, and Informatics for their advice and support in the statistical analysis." (p. 8 of 8)
3) "Conceptualization, A.H., T.J.P.-G. and F.B.; Methodology, A.H. and L.Z.; Validation, A.H; Resources, A.H.; Data curation, A.H.; Writing-original draft, T.J.P.-G.; Supervision, J.D.; Project administration, J.D." (p. 8 of 8)
Detailed Analysis:
ERCT criterion I requires independent conduct, meaning the study is conducted/evaluated by a team independent from the intervention designers, reducing bias.
The paper indicates core roles (conceptualization, methodology, resources, data curation, supervision, project administration, and writing) were performed by the author team. While the authors acknowledge advice/support in statistical analysis, this is not described as an independent external evaluation team conducting the trial or its evaluation.
Final: Criterion I is not met because independent conduct is not evidenced by the study descriptions and author contributions.
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Y
Year Duration
- Outcomes were measured within a single semester (week 7 OSCE to week 12 exam), far short of 75% of an academic year.
- "The intervention group (IG) completed a formative OSCE halfway through the semester (week 7), while the control group (CG) completed the OSCE in week 11, shortly before the final exam in preventive dentistry (week 12)." (p. 2 of 8)
Relevant Quotes:
1) "The intervention group (IG) completed a formative OSCE halfway through the semester (week 7), while the control group (CG) completed the OSCE in week 11, shortly before the final exam in preventive dentistry (week 12)." (p. 2 of 8)
2) "Data were collected using two structured, pseudonymized questionnaires administered at two time points (T0: directly after the OSCE; T1: after the final exam)." (p. 2 of 8)
Detailed Analysis:
ERCT criterion Y requires outcome measurement at least 75% of an academic year after the intervention begins.
The described timeline for the intervention and measurement is within one semester, with the key difference between groups occurring between week 7 and week 11 and final measurement after a week 12 exam. This is substantially less than 75% of an academic year.
Final: Criterion Y is not met because outcomes were measured within only part of a single semester.
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B
Balanced Control Group
- Both groups received the same OSCE resources (same format/stations and duration), and the only difference (timing) is the intended treatment variable, so resource imbalance does not confound the intervention effect.
- "The aim of the study was to compare different timings of a single formative OSCE, not to compare OSCE versus no OSCE. Therefore, no group without OSCE participation was included." (p. 2 of 8)
Relevant Quotes:
1) "All students participated in the OSCE." (p. 2 of 8)
2) "The aim of the study was to compare different timings of a single formative OSCE, not to compare OSCE versus no OSCE. Therefore, no group without OSCE participation was included." (p. 2 of 8)
3) "The formative OSCE consisted of five stations (morphology of teeth, oral hygiene, instruments, anatomy of the oral cavity, dental hard tissue defects and caries diagnosis). Each station lasted eight minutes, with a two-minute changeover period." (p. 2 of 8)
4) "The intervention group (IG) completed a formative OSCE halfway through the semester (week 7), while the control group (CG) completed the OSCE in week 11, shortly before the final exam in preventive dentistry (week 12)." (p. 2 of 8)
Detailed Analysis:
ERCT criterion B checks whether the control group receives comparable educational time/resources, unless any difference in resources is explicitly the treatment variable being tested.
Here, both groups received the same OSCE (same five stations and station duration). The experimental manipulation is the timing of the OSCE (week 7 vs week 11), which inherently changes how much time students have to use the formative experience before the week 12 exam. That timing difference is the study's intended treatment variable ("different timings"), not an unintended resource imbalance.
Under the criterion B decision logic: there is no extra budget/ instructional input given only to the intervention group beyond the OSCE itself, and any timing-related "extra time to react" is integral to what is being tested.
Final: Criterion B is met because both groups receive equivalent OSCE resources, with timing intentionally varied as the treatment variable.
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Level 3 Criteria
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R
Reproduced
- As of the ERCT check date, no independent peer-reviewed replication of this specific randomized timing study was found.
Relevant Quotes:
1) "The aim of this study was therefore to analyze the effect of a one-time formative OSCE in the second preclinical semester on students’ learning behavior, self-assessment, and exam preparation in preventive dentistry." (p. 2 of 8)
Detailed Analysis:
ERCT criterion R requires an independent replication by a different research team in a different context, published in a peer-reviewed journal.
The paper does not describe itself as a replication study, and it does not cite an independent replication of this specific RCT design (randomized timing of a one-time formative OSCE with questionnaire-based outcomes).
Internet searches performed for replications included: queries by DOI (10.1186/s12909-025-08533-5), exact title phrase, and author names (Pfeiffer-Grötz; Basten; Hollinderbäumer; Zöll; Deschner). No clearly independent peer-reviewed replication of this specific study was identified as of 2026-02-15.
Final: Criterion R is not met because no independent replication evidence was found.
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A
All-subject Exams
- Criterion E is not met (no standardized exam-based outcomes), therefore criterion A cannot be met under the ERCT rules.
- "Data were collected using two structured, pseudonymized questionnaires administered at two time points (T0: directly after the OSCE; T1: after the final exam)." (p. 2 of 8)
Relevant Quotes:
1) "Data were collected using two structured, pseudonymized questionnaires administered at two time points (T0: directly after the OSCE; T1: after the final exam)." (p. 2 of 8)
2) "As the OSCE was implemented as a formative, ungraded assessment, no performance scores were recorded for analytical purposes, and students did not receive individual results. Therefore, no correlation with final exam grades was possible." (p. 2 of 8)
Detailed Analysis:
ERCT criterion A requires all-subject standardized exam-based assessment, and the ERCT rules state that if criterion E is not met, criterion A is not met.
This study's measured outcomes are questionnaire-based and the OSCE was ungraded with no recorded performance scores analyzed, so criterion E fails. Therefore, criterion A must also fail.
Final: Criterion A is not met because criterion E is not met and the study does not use standardized all-subject exam outcomes.
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G
Graduation Tracking
- The study measured outcomes only through the final exam within the same semester and (since criterion Y is not met) cannot satisfy graduation tracking; no follow-up-to-graduation papers were found.
- "Data were collected using two structured, pseudonymized questionnaires administered at two time points (T0: directly after the OSCE; T1: after the final exam)." (p. 2 of 8)
Relevant Quotes:
1) "Data were collected using two structured, pseudonymized questionnaires administered at two time points (T0: directly after the OSCE; T1: after the final exam)." (p. 2 of 8)
2) "The intervention group (IG) completed a formative OSCE halfway through the semester (week 7), while the control group (CG) completed the OSCE in week 11, shortly before the final exam in preventive dentistry (week 12)." (p. 2 of 8)
Detailed Analysis:
ERCT criterion G requires tracking participants through graduation at the relevant educational stage. Additionally, ERCT rules state: if criterion Y (Year Duration) is not met, then criterion G is not met.
In this paper, the latest reported measurement time is "after the final exam" in the same semester. No outcomes are reported beyond that exam window, and there is no description of follow-up to any graduation milestone.
Internet searches for follow-up publications by the same author team (queries by DOI and exact title, plus author-name searches) did not identify any subsequent peer-reviewed papers reporting graduation tracking for this cohort as of 2026-02-15.
Final: Criterion G is not met because the study does not track to graduation, and criterion Y is not met.
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P
Pre-Registered
- No pre-registration statement, registry/platform ID, or timing evidence is provided, and no external preregistration record was found by DOI/title searches.
Relevant Quotes:
1) "The study was previously presented to the Ethics Committee Rhineland-Palatinate, which waived the requirement for a formal procedure number as the project was classified as educational quality assurance." (p. 2 of 8)
2) "For this reason, there is no procedure number for this study." (p. 8 of 8)
Detailed Analysis:
ERCT criterion P requires an explicit pre-registration reference (registry/platform and ID) and evidence that registration occurred before data collection began.
The paper provides an ethics/quality-assurance description and explicitly notes there is no procedure number, but it does not provide any preregistration registry name (e.g., OSF, ISRCTN, ClinicalTrials.gov/DRKS), any registration identifier, or any preregistration date.
Additional internet searches by DOI and exact title (including searches for OSF/preregistration pages) did not locate a clear preregistered protocol record for this study as of 2026-02-15.
Final: Criterion P is not met because no preregistration ID/date evidence is reported or found.
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