Ease of use of digital impression systems for dentists of different ages
| ISRCTN | ISRCTN59180426 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59180426 |
| Secondary identifying numbers | Version 1.0 (Date 11/10/2017) |
- Submission date
- 11/12/2017
- Registration date
- 27/02/2018
- Last edited
- 14/01/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Intraoral digital impression (IDI) is a new procedure introduced to dental practice to assure more comfort to the patient and improve quality and the time usage of dentists. Being new, IDI needs practice to become easier for dentists. The aim of this study is to compare the facility of learning and quality of impressions done by different practitioners of different age categories using IDI.
Who can participate?
Healthy volunteers aged 22 and over
What does the study involve?
Dentists of three age categories are recruited: category A are dentists aged over 40 with no previous experience in the use of IDI, category B are pre-graduate dental students aged under 25 with no previous experience in the use of IDI, and category C are practitioners experienced with IDI. Patients are assigned to the different groups of dentists. Each patient has conventional impressions using trays and silicone material, and models of their teeth are poured in plaster. Three randomly chosen groups start with the 3Shape system and the other three with the LAVA system (same procedure for the two systems). On the first day, the dentists have an introduction session to IDI systems, 15 minutes training on a plastic model, and create a digital impression of the patients (time and quality of the IDI are recorded). On day 2 and day 3 the dentists do 60 minutes of training on each other, rotating each 20 minutes, so each dentist can do 20 minutes practice, 20 minutes assisting, and 20 minutes as a patient. On day 4 the dentists create another digital impression of the patients (time and impression quality are recorded). By the end, the groups switch systems and the same steps are repeated so that each group has used both systems.
What are the possible benefits and risks of participating?
There are no risks of any kind for the patients participating in this study.
Where is the study run from?
1. Geneva School of Dentistry (Switzerland)
2. University Complutense Madrid (Spain)
When is the study starting and how long is it expected to run for?
December 2017 to March 2018
Who is funding the study?
University of Geneva (Switzerland)
Who is the main contact?
Prof. Irena Sailer
Contact information
Scientific
Division de Prothèse Fixe et Biomateriaux
Clinique Universitaire de Médecine Dentaire
Faculté de Médecine
Section de médecine dentaire
Rue Barthélemy-Menn 19
Geneva
1211
Switzerland
Study information
| Study design | Observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Ease of use and adaptability of clinicians of different generations to different intraoral digital impression systems |
| Study objectives | 1. No differences will be found between groups with respect to times spend completing the intraoral digital impressions 2. No differences will be found between groups with respect to quality of the digital models |
| Ethics approval(s) | Comité d'éthique du canton Geneve (ethics committee of Geneva canton) - approval pending |
| Health condition(s) or problem(s) studied | Intraoral digital impression - dentistry |
| Intervention | The study is held in 2 centers (Geneva school of dentistry and University Complutense Madrid). In each center, 6 dentists of 3 age categories will be recruited: Category A: dentists aged > 40 years with no previous experience in the use of Intraoral Digital Impression Systems Category B: pre-graduate dental students, aged < 25 years, with no previous experience in the use of Intraoral Digital Impression Systems Category C: control practitioners experienced with IDI systems 6 groups will be formed of 3 dentists: 1 of each category, and 1 patient will be assigned to each group. The recruitment of the 6 patients per center will be done prior to the attribution, patients are healthy adults with good oral hygiene and oral stability. Each patient will have conventional impressions using trays and silicone material, and models of his teeth will be poured in plaster to be the control models. Once formed, 3 randomly chosen groups will start with 3Shape system and the other 3 with the LAVA system (same procedure for the 2 systems), and by the end , groups will switch systems so that each group would have used both systems. On the first day, groups will have an introduction session to IDI systems, 15 min training on a plastic model, and baseline digital impression on patients (time and quality of Basleine IDI are recorded) Day 2 and day 3: 60 minutes of training on each other, rotating each 20 min, so each dentist can do 20 min practice, 20 min assisting, and 20 min as a patient Day 4: Test digital impression on patients (time and impression quality recorded) By the end, groups will switch systems so that each group would have used both systems and same steps are repeated. Impression times recorded will be analysed by computer. Using Geomagic X software, the quality of the IDI impressions will also be compared to the initial plaster models. |
| Intervention type | Behavioural |
| Primary outcome measure | Time needed to complete an intraoral digital impression, measured in minutes and seconds using a stopwatch, for the first impression (baseline impression) and the final impression done after two training sessions |
| Secondary outcome measures | Quality of the digital impressions compared to the initial plaster models, measured quantitatively by calculating using Geomagic X software: 1. Percentage of completeness of region of interest of digital model 2. Cumulative noise and errors of region of interest of digital model |
| Overall study start date | 01/12/2017 |
| Completion date | 30/03/2018 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 6 patients per center (12 patients in total) |
| Key inclusion criteria | 1. ≥22 years of age 2. Capable of providing written informed consent 3. Obtained informed consent from the patient 4. Intra-oral health 5. Patients with adequate oral hygiene Plaque Index <20%, BoP < 20% 6. Occlusal stability (fully dentate or partially edentulous: no more than 1 tooth missing per quadrant) |
| Key exclusion criteria | 1. Medical condition: ASA -score ≥ III 2. History of radiotherapy in the head and neck region 3. History of bisphosphonate medication 4. Women of childbearing potential with a positive urine pregnancy test 5. Patients unwilling or incapable of understanding and signing the informed consent 6. Dental disease: active caries or periodontal inflammation |
| Date of first enrolment | 01/12/2017 |
| Date of final enrolment | 01/02/2018 |
Locations
Countries of recruitment
- Spain
- Switzerland
Study participating centres
Rue Michel-Servet 1
Geneva
1211
Switzerland
Spain
Sponsor information
University/education
Division of fixed prosthodontics and biomaterials
Faculté de Médecine
Section de médecine dentaire
Rue Barthélemy-Menn 19
Geneva
1211
Switzerland
| Website | https://www.unige.ch/medecine/dentaire/fr/organ/de/divi/ |
|---|---|
"ROR" |
https://ror.org/01m1pv723 |
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- University of Geneva, UNIGE
- Location
- Switzerland
Results and Publications
| Intention to publish date | 01/04/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/12/2021 | 14/01/2022 | Yes | No |
Editorial Notes
14/01/2022: Publication reference added.
