Self-AssessmentNCT06567236
E4D Compare Adapted to Preclinical Endodontics
A study testing 3D software in people with Self-Assessment and Self-Perception, run by Texas A&M University at 1 site in United States.
Trial summary
Based on pilot study's promising results, we decided to further investigate the impact of adapting Planmeca Romexis Compare software to evaluate pulpal access preparations on second-year dental students' technical performance, self-evaluation skills and opinions. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Self-Assessment, Self-Perception
- What is being tested?
- 3D software
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2023to 8 May 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Second-year dental students enrolled in DDDS 719 Integrated Practice of Dentistry Lab II during 2022-2023 at Texas A\&M School of Dentistry
- Students who have completed fixed prosthodontics preclinical course
- Students attending the endodontics preclinical course.
Who cannot join
- First, third and fourth-year dental students at Texas A\&M School of Dentistry
- Second-year dental students NOT enrolled in DDDS 719 Integrated Practice of Dentistry Lab II during 2022-2023 at Texas A\&M School of Dentistry
- Students who are not interested in participating.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: E4D Compare Adapted to Evaluate Pulpal Access Cavity Preparation in the D2 Preclinical Endodontics Course: Educational Randomized Controlled Trial
Based on pilot study's promising results, we decided to further investigate the impact of adapting Planmeca Romexis Compare software to evaluate pulpal access preparations on second-year dental students' technical performance, self-evaluation skills and opinions. No educational records, grades, coursework, or any other assignments that are completed as part of the regular class will be analyzed as part of this study.
- Conditions
- Self-Assessment, Self-Perception
- Being tested
- 3D software
- Keywords
- Endodontics, Predental education, Educational technology, Teaching methods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D softwareOther
Participants in the experimental arm will receive extra training on Planmeca Romexis Compare Software adapted to evaluate endodontic access preparation.
| Study group | Role | What they receive |
|---|---|---|
| Traditional teaching method | No intervention | Participants will be exposed to traditional teaching method. |
| 3D software teaching method. | Experimental | Participants will be exposed to traditional teaching method and 3D software teaching method. Receives: Other: 3D software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-assessment - traditional method vs traditional method plus 3D software method
Compare self-assessment after traditional method only and with extra 3D software method
Measured: baseline, 2 weeks, 4 weeks, 5 weeks and 7 weeks
Grading - traditional method vs traditional method plus 3D software method
Compare technical skills after traditional method only and with extra 3D software method
Measured: baseline, 2 weeks, 4 weeks, 5 weeks and 7 weeks
Secondary outcomes (1)
Grading - traditional/visual grading vs 3D software grading
Compare traditional/visual grading to 3D software grading using different tolerance levels
Measured: baseline, 2 weeks, 4 weeks, 5 weeks and 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start27 Feb 2023
- Primary completion8 May 2023
- Study completion8 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Self-AssessmentStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567236
- Sponsor's protocol ID
- IRB2022-1492-CD-EXM
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Poly A, Burnett JE, Buie CA, Schweitzer JL. Three-dimensional software adapted to evaluate endodontic access cavity preparation. J Dent Educ. 2023 Dec;87 Suppl 3:1848-1851. doi: 10.1002/jdd.13216. Epub 2023 Apr 11. No abstract available.
PubMed 37016471
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E4D Compare Adapted to Evaluate Pulpal Access Cavity Preparation in the D2 Preclinical Endodontics Course: Educational Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06567236
- Acronym / sponsor ID
- IRB2022-1492-CD-EXM
- Conditions
- Self-Assessment, Self-Perception
- Keywords
- Endodontics, Predental education, Educational technology, Teaching methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 8 May 2023 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 22 Aug 2024 (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.
Based on pilot study's promising results, we decided to further investigate the impact of adapting Planmeca Romexis Compare software to evaluate pulpal access preparations on second-year dental students' technical performance, self-evaluation skills and opinions. No educational records, grades, coursework, or any other assignments that are completed as part of the regular class will be analyzed as part of this study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional teaching method | No intervention | –Participants will be exposed to traditional teaching method. |
| 3D software teaching method. | Experimental | Other: 3D softwareParticipants will be exposed to traditional teaching method and 3D software teaching method. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Second-year dental students enrolled in DDDS 719 Integrated Practice of Dentistry Lab II during 2022-2023 at Texas A\&M School of Dentistry
- Students who have completed fixed prosthodontics preclinical course
- Students attending the endodontics preclinical course.
Key exclusion criteria (3 listed)
- First, third and fourth-year dental students at Texas A\&M School of Dentistry
- Second-year dental students NOT enrolled in DDDS 719 Integrated Practice of Dentistry Lab II during 2022-2023 at Texas A\&M School of Dentistry
- Students who are not interested in participating.
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 |
|---|---|---|
| 3D softwareParticipants in the experimental arm will receive extra training on Planmeca Romexis Compare Software adapted to evaluate endodontic access preparation. | Other | 3D software teaching method. |
Primary outcome
Self-assessment - traditional method vs traditional method plus 3D software method
Time frame: baseline, 2 weeks, 4 weeks, 5 weeks and 7 weeks
Compare self-assessment after traditional method only and with extra 3D software method
Grading - traditional method vs traditional method plus 3D software method
Time frame: baseline, 2 weeks, 4 weeks, 5 weeks and 7 weeks
Compare technical skills after traditional method only and with extra 3D software method
1 secondary outcome
Grading - traditional/visual grading vs 3D software grading
Time frame: baseline, 2 weeks, 4 weeks, 5 weeks and 7 weeks
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 22 Aug 2024.
- Background: PubMed 37016471Poly A, Burnett JE, Buie CA, Schweitzer JL. Three-dimensional software adapted to evaluate endodontic access cavity preparation. J Dent Educ. 2023 Dec;87 Suppl 3:1848-1851. doi: 10.1002/jdd.13216. Epub 2023 Apr 11. No abstract available.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D software in people with Self-Assessment and Self-Perception, run by Texas A&M University at 1 site in United States.
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 3 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 22 Aug 2024. 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 United States. 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?
Self-assessment - traditional method vs traditional method plus 3D software method (time frame: baseline, 2 weeks, 4 weeks, 5 weeks and 7 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06567236, which also lists 1 linked publication.
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 22 Aug 2024.