Comparing the accuracy of Intraoral scanning (IOS) versus stereophotogrammetry (SPG) for impressions of dental implants for toothless patients
| ISRCTN | ISRCTN12501259 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12501259 |
| Secondary identifying numbers | Version 01 |
- Submission date
- 22/03/2021
- Registration date
- 13/10/2021
- Last edited
- 04/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
The purpose of this project is to compare the accuracy of two digital impression techniques that can be used to create dental prosthetics to replace missing teeth. Defining the level of accuracy of these technologies will allow dentists to improve the workflow for creating these prosthetics and reduce the discomfort for patients. Traditionally these prosthetics are created using a plaster impression of the mouth which is then used as a mould to create the prosthetic. The ongoing development of digital technologies led to a more accurate and sophisticated way to achieve the exact 3D position of dental implants even in completely toothless jaws. Intraoral digital optical scanning (IOS) has been claimed as an alternative to the conventional implant impression even though the complete-arch implant impression by means of IOS is still considered one of the most challenging. Stereophotogrammetry (SPG) technology uses a double stereo camera to detect where the scan bodies are positioned.
Who can participate?
Healthy adults requiring a complete-arch implant-supported fixed dental prosthesis (FDP) of the upper and lower jaw
What does the study involve?
Eligible participants will have a plaster implant impression made of the area of their mouth where the teeth are missing and so a prosthetic is required. A plaster implant impression is currently considered the gold standard for this procedure and will be used to make the models for the prosthetic to be produced. Following this digital impressions will be taken using both SPG and IOS techniques to scan the mouth. The digital impressions will be compared by the researcher.
What are the possible benefits and risks of participating?
It is hoped that this study will benefit future patients by improving the prosthetic workflow and reducing patient discomfort.
Participation in the study is completely voluntary and participants can withdraw at any time.
Where is the study run from?
Policlinico Tor Vergata (Italy)
When is the study starting and how long is it expected to run for?
From January 2021 to October 2021
Who is funding the study?
Investigator-initiated and funded
Who is the main contact?
Dr Paolo Carosi, carosipaolo29@gmail.com
Contact information
Public
Via della Ricerca scientifica 1
Rome
00133
Italy
 ORCID ID |
0000-0002-2442-1091 |
|---|---|
| Phone | +39 3277998699 |
| Paolo.carosi@alumni.uniroma2.eu |
Scientific
Via della Ricerca scientifica 1
Rome
00133
Italy
| ORCID ID |
0000-0002-6152-3337 |
|---|---|
| Phone | +3928849818 |
| lorenzo.arcuri@uniroma2.it |
Study information
| Study design | Interventional non-randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 39675_PIS_09Dec2019.pdf |
| Scientific title | Intraoral scanning (IOS) versus stereophotogrammetry (SPG) for complete-arch implant impression: A prospective in vivo study on 15 edentulous jaws |
| Study acronym | IOSVSSPG |
| Study objectives | To assess the accuracy of IOS and stereophotogrammetry for complete-arch implant impressions in vivo. |
| Ethics approval(s) | Approved 28/10/2020, Independent Ethical Committee Policlinico Tor Vergata (Viale Oxford, 81, 00133 Roma RM, Italy; +39 06-2090 0035; alessandra.nistri@ptvonline.it), ref: 203.20 |
| Health condition(s) or problem(s) studied | Implant-supported complete arch restorations of edentulous jaw |
| Intervention | The recruited patients of our study received a full-arch implant supported rehabilitation by means of a screw-retained fixed prosthesis in the last 3 years. After the Ethical Committee approval we scanned with IOS and with SPG the patients and obtained STL files, which have been analyzed and superimposed in order to obtain accuracy data. There will be no follow-up of patients. Assuming Euclidean distance as primary measure of discrepancy, the aim of this study will be to determine whether stereophotogrammetry significantly increases the expected accuracy in comparison to IOS. Reference scan: Implant transfers were screwed onto the implants and gypsum impressions were taken. Consequently, the impressions were poured and digitized by means of a structured blue light 3D optical desk scanner (E4, 3Shape, Copenaghen, Denmark) with a declared accuracy of 4 μm (ISO 12836), properly calibrated before the scanning, in order to achieve a standard tessellation language (STL) file to be used as reference. The digital file obtained was used also as a master model for the definitive complete-arch rehabilitation. Test scans: The IOS device investigated was a cabled pen grip (Trios3, 3Shape A/S, Copenhagen, Denmark) with the software version 1.6.10.1. It is a powder-free scanner, based on confocal microscopy laser technology. The SPG device investigated was The PICcamera® (PICdental, Madrid, Spain) is a stereo-camera that records implant positions in the mouth by means of photogrammetry. It comprises two CCD cameras specially designed and optimized for clinical use, which accurately determine the position of the implants by means of the identification of abutments screwed on implants with unique individual coding (PICabutment®, PICdental). One operator, an expert in digital impressions recorded 2 impressions with the IOS and the SPG on each patient according to the guidelines of the device producers. Data processing and accuracy assessment: The 30 test STL files were aligned to the reference scan with dedicated software (Geomagic Studio 12, 3DSystems, Rock Hill, SC, USA), according to a 0.01 mm alignment tolerance, and 2 alignment optimizations were accomplished after the file superimposition. At last, linear and angular deviations between each test scan and the reference scan were measured for any analogue, analyzing the previously superimposed files through a dedicated measurement software (Hyper Cad S, Cam HyperMill, Open Mind Technologies, Milano, Italy). Linear deviations were assessed for each analogue on the three space axis (X longitudinal, Y lateral, and Z vertical). Negative and positive values depend on the alignment of each test scan with the reference scan and, considering the reference axis system used, must be interpreted as follows: negative values on the X, Y, and Z axis featured a scan body positioned frontward, left, and downward respectively, while the positive ones are in the opposite direction on each axis. 3D deviation was calculated using Euclidean distance. Angular deviations were assessed as the angles formed by the two lines passing perpendicularly through the centers of the test image and the reference image of each implant. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Accuracy measured by analyzing linear and angular deviations between each test scan and the reference scan using a dedicated measurement software (Hyper Cad S, Cam HyperMill, Open Mind Technologies, Milano, Italy) |
| Secondary outcome measures | The effect of stereophotogrammetry versus IOS, adjusting for possible confounding factors, will be measured using the General Linear Model at multivariate analysis |
| Overall study start date | 08/01/2021 |
| Completion date | 15/10/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 15 arches (84 implants) |
| Key inclusion criteria | 1. Healthy patients aged ≥18 years 2. Full mouth bleeding and full mouth plaque index lower than or equal to 25% 3. Bone height for at least 10 mm long implants 4. Bone width of at least 5 mm and 6 mm for narrow (NP 3.75/3.5 mm) and regular (RP 4.3 mm) implants, respectively 5. Fresh extraction sockets with an intact buccal wall 6. At least 4 and 5 mm of bone beyond the root apex in the mandible and maxilla 7. Minimal insertion torque of 45 Ncm |
| Key exclusion criteria | 1. General medical (American Society of Anesthesiologists, ASA, class III or IV) and/or psychiatric contraindications 2. Pregnancy and/or breastfeeding 3. Any interfering medication such as steroid therapy or bisphosphonate therapy 4. Alcohol and/or drug abuse 5. Heavy smoking (>10 cigarettes/day) 6. Radiation therapy to head or neck region within 5 years 7. Untreated periodontitis 8. Acute and chronic infections of the adjacent tissues or natural dentition 9. Severe maxillomandibular skeletal discrepancy 10. High and moderate parafunctional activity 11. Absence of opposite teeth |
| Date of first enrolment | 29/03/2021 |
| Date of final enrolment | 30/05/2021 |
Locations
Countries of recruitment
- Italy
Study participating centre
Roma
00133
Italy
Sponsor information
University/education
Via Montpellier, 1
Rome
00133
Italy
| Phone | +39 (0)6 7259 6798 |
|---|---|
| segr-studenti-odonto@med.uniroma2.it | |
| Website | http://web.uniroma2.it/home.php?newlang=italian |
"ROR" |
https://ror.org/02p77k626 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 15/10/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 will be available upon request from the corresponding author Paolo Carosi (Paolo.carosi@alumni.uniroma2.eu) as raw data from the publication date of the article for 1 year. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 09/12/2019 | 04/10/2021 | No | Yes |
Additional files
Editorial Notes
04/10/2021: Trial’s existence confirmed by Independent Ethical Committee Policlinico Tor Vergata.
