Health Knowledge, Attitudes, PracticePlaydentNCT05348018
Serious Games for Training in Oral Rehabilitation
A study testing Playing Serious Games during a four-week test period in addition to conventional lectures in people with Health Knowledge, Attitudes, Practice, run by Hôpital Rothschild at 1 site in France.
Trial summary
Coronavirus disease-19 (COVID-19) dramatically changed the learning conditions of dental students, with restricted access to training sessions and clinical practice. The "Playdent" project proposed the integration of serious games (SGs) in the third-year curriculum, based on tailor-made scenarios questioning the first… Read more about this study
- Who is it for?
- Ages 20 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Knowledge, Attitudes, Practice
- What is being tested?
- Playing Serious Games during a four-week test period in addition to conventional lectures
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteFrance
- Study dates
- 12 Feb 2021to 30 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- adult students (aged at least 18)
- enrolled in the third-year at the faculty of dental surgery of the University of Paris,
- agreeing to participate in the study
Who cannot join
- Third-year students who had repeated their courses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of Game-based Training in Oral Rehabilitation of Edentulous Patients in Undergraduate Dental Course
Coronavirus disease-19 (COVID-19) dramatically changed the learning conditions of dental students, with restricted access to training sessions and clinical practice. The "Playdent" project proposed the integration of serious games (SGs) in the third-year curriculum, based on tailor-made scenarios questioning the first dental visit of edentulous patients, and examined whether training with the games would advance students' learning outcomes.
Read the detailed description
Three Serious games proposed in addition to conventional lectures and practical exercises in oral rehabilitation of edentulous patients were supposed to improve knowledge and skills of undergraduates. However, in order to assess the influence of SGs on students' learning outcomes and subsequent satisfaction, a single-blind controlled protocol was designed. The null hypothesis was that SGs had no impact on the learning outcomes of undergraduate students.
- Conditions
- Health Knowledge, Attitudes, Practice
- Being tested
- Playing Serious Games during a four-week test period in addition to conventional lectures
- Keywords
- health education
- Medical subject headings
- Behavior, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Playing Serious Games during a four-week test period in addition to conventional lecturesDevice
Playing SGs during a four-week test period in addition to conventional lectures in oral rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| "test" group | Experimental | "test" group which accessed SGs during a four-week test period in addition to conventional lectures Receives: Device: Playing Serious Games during a four-week test period in addition to conventional lectures |
| "control" group | No intervention | "control" group which benefited solely from conventional lectures |
What is being measured
The primary outcome is the main question the study is designed to answer.
performance
Students' performance for managing a dental visit of edentulous patients were assessed by measuring score to a test developed by the teaching team. Scores were calculated ranging from 0 (no correct answer) to 15 (100% correct answers).
Measured: One month
Secondary outcomes (1)
students' satisfaction
a questionnaire was drawn up for the students in the form of an self-administered questionnaire, which included questions pertaining to their satisfaction ranging from 0 (=very unsatisfactory) to 10 (=very satisfactory).
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start12 Feb 2021
- Primary completion20 Apr 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Knowledge, Attitudes, PracticeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were allocated either to a "test" group which accessed Serious games during a four-week test period in addition to conventional lectures or to a "control" group which benefited solely from conventional lectures
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Rothschild
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Braud Adeline, Hôpital Rothschild
- Investigators
- Adeline Braud, PhD, Principal investigator, Unievrsité de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348018
- Sponsor's protocol ID
- PlY01
- Acronym
- Playdent
- Status last verified
- Mar 2023
- First submitted
- 19 Apr 2022
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Game-based Training in Oral Rehabilitation of Edentulous Patients in Undergraduate Dental Course
- ClinicalTrials.gov ID
- NCT05348018
- Acronym / sponsor ID
- Playdent / PlY01
- Conditions
- Health Knowledge, Attitudes, Practice
- Keywords
- health education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Hôpital RothschildUniversity, hospital or other
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Coronavirus disease-19 (COVID-19) dramatically changed the learning conditions of dental students, with restricted access to training sessions and clinical practice. The "Playdent" project proposed the integration of serious games (SGs) in the third-year curriculum, based on tailor-made scenarios questioning the first dental visit of edentulous patients, and examined whether training with the games would advance students' learning outcomes.
Detailed description
Three Serious games proposed in addition to conventional lectures and practical exercises in oral rehabilitation of edentulous patients were supposed to improve knowledge and skills of undergraduates. However, in order to assess the influence of SGs on students' learning outcomes and subsequent satisfaction, a single-blind controlled protocol was designed. The null hypothesis was that SGs had no impact on the learning outcomes of undergraduate students.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were allocated either to a "test" group which accessed Serious games during a four-week test period in addition to conventional lectures or to a "control" group which benefited solely from conventional lectures
| Arm | Type | Receives |
|---|---|---|
| "test" group | Experimental | Device: Playing Serious Games during a four-week test period in addition to conventional lectures"test" group which accessed SGs during a four-week test period in addition to conventional lectures |
| "control" group | No intervention | –"control" group which benefited solely from conventional lectures |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- adult students (aged at least 18)
- enrolled in the third-year at the faculty of dental surgery of the University of Paris,
- agreeing to participate in the study
Key exclusion criteria (1 listed)
- Third-year students who had repeated their courses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Playing Serious Games during a four-week test period in addition to conventional lecturesPlaying SGs during a four-week test period in addition to conventional lectures in oral rehabilitation | Device | "test" group |
Primary outcome
performance
Time frame: One month
Students' performance for managing a dental visit of edentulous patients were assessed by measuring score to a test developed by the teaching team. Scores were calculated ranging from 0 (no correct answer) to 15 (100% correct answers).
1 secondary outcome
students' satisfaction
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adeline Braud, PhD principal investigator
Unievrsité de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Playing Serious Games during a four-week test period in addition to conventional lectures in people with Health Knowledge, Attitudes, Practice, run by Hôpital Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
performance (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.