Comparing the fit of ceramic inlays made from silicone and digital impressions of the mouth
| ISRCTN | ISRCTN84062376 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84062376 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | SPP-R-001 |
| Sponsor | Instituto Odontologico Integral Avanzado, SL |
| Funder | Instituto Odontologico Integral Avanzado, SL |
- Submission date
- 17/05/2021
- Registration date
- 07/06/2021
- Last edited
- 08/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Inlays are a type of tooth restoration used to treat cavities in the teeth. Inlays are fitted into the grooves of the tooth and the shape of the hole/cavity. Computer-aided design/computer-aided manufacturing (CAD-CAM) can be used to produce inlays with a better fit, which is crucial to avoid bacterial leakage and clinical complications. Using a traditional impression technique (using a silicone putty to create a mould of the tooth) may assure a precise reproduction with a close fit. The aim of this study is to compare inlays made based on digital impressions using CAD/CAM techniques or traditional silicone impression techniques.
Who can participate?
Healthy adults who are in need of one or two inlays on molar teeth
What does the study involve?
An inlay will be made for each tooth that requires an inlay from dental impressions taken traditionally (using putty) or made using digital impression techniques. The fit of each crown is determined using a microscope. How well each of the crowns fit will then be compared.
What are the possible benefits and risks of participating?
A benefit of taking part in the study is that participants are able to receive their dental inlays at a discounted price. The risks of participating are minor and include the general risks associated with dental surgery.
Where is the study run from?
University of Granada (Spain)
When is the study starting and how long is it expected to run for?
September 2019 to January 2021
Who is funding the study?
Instituto Odontologico Integral Avanzado (IOIA) (Spain)
Who is the main contact?
Mr. Franklin G. Vargas Corral
fgvargas@ioia.es
Contact information
Scientific
AVDA. del Conocimiento, 41. O A001
Granada
18016
Spain
 ORCID ID |
0000-0003-0831-9828 |
|---|---|
| Phone | +34 (0)691163753 |
| fgvargas@ioia.es |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Clinical evaluation comparing the fit of ceramic inlays obtained from silicone and digital intraoral impressions |
| Study objectives | There is no difference in accuracy between the fit of the inlays fabricated with the digital impression and the conventional impression. |
| Ethics approval(s) | Approved 12/05/2020, comite etico de la universidad de Granada (Ethical committee of Granada University, Vicerrectorado De Investigacion Y Transferencia, University of Granada, 48 Gran via De Colon, Granada, 18071, Spain; +34 (0)958243008; investigacion@ugr.es), ref: #1456/CEIH/2020 |
| Health condition(s) or problem(s) studied | Dental cavities |
| Intervention | Each tooth included in the study is the investigation unit (or specimen). Each tooth is prepared for inlay, and two impressions are taken on each tooth (one digital and one conventional). One inlay is produced for each tooth with a conventional impression or digital impression. Randomization is conducted using a mobile application. After fitting the definitive restoration to the clinical preparation, with no occlusal checkup, it is placed in the oral cavity and an impression is taken of the occlusal and non-occlusal interfaces using polyvinyl siloxane addition silicone. Samples are stored in transparent, hermetic bags that are coded to ensure their analysis in a blinded fashion. The same restoration used for the measurements is then cemented in the dental preparation for which it was prepared. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Inlays made using CAD/CAM techniques, inlays made using silicone impression techniques |
| Primary outcome measure(s) |
Marginal gap of ceramic inlays measured using white light confocal microscopy between 3 and 8 days after the replication of the fit |
| Key secondary outcome measure(s) |
Overextension of ceramic inalys measured using white light confocal microscopy between 3 and 8 days after the replication of the fit |
| Completion date | 01/01/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 31 |
| Total final enrolment | 31 |
| Key inclusion criteria | 1. In need of 1-2 (if located in contra-lateral quadrants and opposing arches) inlays on molar teeth 2. Subject tooth/teeth are free of clinical symptoms 3. No requirement for additional endodontic treatment expressed by the presence of a periapical radiolucency around an endodontically treated tooth or a root canal filling <3 months 4. Adequate level of oral hygiene expressed by the absence of signs of periodontal inflammation, bleeding on probing, and periodontal pocket depth <4 mm |
| Key exclusion criteria | 1. Advanced periodontitis affecting the mobility of the teeth (mobility degree 2 or higher) 2. Clinical history of bruxism 3. Pregnant or lactating females 4. Marginal preparation situated deeper than 1 mm subgingival |
| Date of first enrolment | 18/05/2020 |
| Date of final enrolment | 01/09/2020 |
Locations
Countries of recruitment
- Spain
Study participating centre
Prosthodontic Section
Campus de Cartuja S/N
Granada
18071
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 23/02/2024 | 08/08/2024 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
08/08/2024: Publication reference added.
08/02/2022: The intention to publish date was changed from 01/01/2022 to 01/06/2022.
01/06/2021: Trial's existence confirmed by the ethics committee of the University of Granada.
