Immersive reality innovation as an open and closed method tooth extraction simulator to increase the competency achievement of students and dentists
| 1. Background | |
|---|---|
| Registration Number | INA-QES4CC5 |
| Date of registry approval | 18-11-2024 |
| Registration Date | 15-11-2024 |
| Secondary identifiers | No |
| Name of issuing authority (for example protocol number, other registries, etc) | |
| Secondary identifier number | |
| Scientific study title | Immersive reality innovation as an open and closed method tooth extraction simulator to increase the competency achievement of students and dentists |
| Public (popular study title) | Immersive reality innovation as an open and closed method tooth extraction simulator to increase the competency achievement of students and dentists |
| 2. Sponsor and Funding | |
| Primary Sponsor | Not Specified |
| Source(s) of monetary or material support | Not Specified |
| Other partners | Universitas Padjajaran, Universitas Sumatera Utara, University of California |
| 3. Contact details | |
| Principal Investigator | |
| Principal investigator | Prof. Muhammad Ruslin, drg., M.Kes., Ph.D., Sp.BM (K) |
| City | Makassar |
| Country | Indonesia |
| Principal investigator's affiliation | Fakultas Kedokteran Gigi, Universitas Hasanuddin |
| Principal Investigator's email address | mruslin@unhas.ac.id |
| Public Queries | |
| Contact person name for public queries | Prof. Muhammad Ruslin, drg., M.Kes., Ph.D., Sp.BM (K) |
| Address for public queries | Jl. Marahaban Selatan No. 6 Bukit Baruga Antang |
| City | Makassar |
| Country | Indonesia |
| ZIP | 90234 |
| Affiliation for public queries | Fakultas Kedokteran Gigi, Universitas Hasanuddin |
| Email address for public queries | mruslin@unhas.ac.id |
| Phone number for public queries | 0811236191 |
| Scientific Queries | |
| Name of Contact for scientific queries | Prof. Muhammad Ruslin, drg., M.Kes., Ph.D., Sp.BM (K) |
| Address for scientific queries | Jl. Marahaban Selatan No. 6 Bukit Baruga Antang |
| City | Makassar |
| Country | Indonesia |
| ZIP | 90234 |
| Affiliation of scientific queries contact | Fakultas Kedokteran Gigi, Universitas Hasanuddin |
| Email address for scientific queries | mruslin@unhas.ac.id |
| 4. IRB & Regulatory | |
| Ethical Approval number | 001/KEPK FKG_RSGMP UH/EE/IX/2024 |
| Name of Ethics committee | Komite Etik Penelitian Kesehatan Fakultas Kedokteran Gigi dan Rumah Sakit dan Mulut Pendidikan Universitas Hasanuddin |
| Date of Ethic approval | 02-10-2024 |
| Contact details of Ethic Committee (phone, email, and office) | 082251958134 |
| Number of Persetujuan Pelaksanaan Uji Klinik (PPUK)/Persetujuan Protokol Uji BE (PPUB) | Not applicable |
| 5. Status | |
| Countries of recruitment | Indonesia |
| Study sites in Indonesia | Fakultas Kedokteran Gigi, Universitas Hasanuddin |
| Recruitment status | Initial |
| Date of first enrollment | 22-11-2024 |
| Targeted Sample size | 00090 - |
| Number of enrolled participants | All dental and oral patients |
| Date of study completion (last participant, last visit) | |
| 6. Study Design & Purpose | |
| Primary health condition(s) or problem(s) studied (e.g., depression, breast cancer,medication error) | Gigi Impaksi dan Gangren Pulpa |
| Purpose of the study | Treatment Planning |
| Study type | Observational |
| Method of allocation | |
| Description of the allocation concealment mechanism and sequence generation | |
| Masking | |
| Study intervention (study arm) | |
| Control intervention (control arm) | |
| Intervention assignment | |
| 7. Eligibility Criteria | |
| Gender inclusion criteria | Male, Female |
| Minimum age | 21 |
| Maximum age | Not Specified |
| Inclusion criteria | Kriteria inklusi subjek pada penelitian ini antara lain:
▪ Sampel merupakan mahasiswa kedokteran gigi, yang telah menempuh masa pendidikan sekurang-kurangnya 4 (empat) semester. ▪ Sampel memiliki pemahaman dasar mengenai pencabutan gigi teknik open dan closed method. |
| Exclusion criteria | Participants were unable to follow the research procedures until they were completed due to
health problems |
| 8. Study Outcome | |
| Primary Outcome | |
| Name of primary outcome | Knowledge and Skills |
| Metric/method of measurement | Quetionare |
| Timepoint(s) of measurement | Cross-Sectional |
| 9. Study Results | |
| Brief summary of study results | |
| Date of results summaries | |
| Participant flow | |
| Baseline characteristic | |
| Adverse events | |
| Outcome measures | |
| 10. Publication | |
| URL hyperlink(s) related to results and publications | https://jkamprs.springeropen.com/ |
| IPD sharing statement (Statement regarding the intended sharing of deidentified individual clinical trial participant-level data (IPD)) | No |
| Plan for IPD sharing (what IPD will be shared, when, by what mechanism, with whom, and for what types of analyses) | |
| Other important informations | Not Specified |