Comparing the accuracy of digital impressions with conventional impressions
| ISRCTN | ISRCTN16111844 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16111844 |
| Secondary identifying numbers | C.I.011/170 |
- Submission date
- 08/09/2015
- Registration date
- 29/09/2015
- Last edited
- 27/11/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Taking impressions of teeth (dental impressions) are vital for all dental restoration surgeries. Traditionally, dentists take impressions by asking the patient to “bite down” on synthetic putty, so that a 3D mold of the teeth could be made. In recent years, the use of computerised systems has been used more and more in dentistry. Many dentists now use digital impression and scanning systems to take accurate impressions of the teeth, which are considered to be a faster and more accurate way of taking dental impressions. The aim of this study is to find out whether dental crowns (a tooth-shaped "cap" that is placed over a tooth) made using traditional impression methods (putty) or a digital impression system fit better in the patient.
Who can participate?
Healthy adults who are in need of one or two crowns on pre-molar teeth.
What does the study involve?
Two dental crowns are made for each tooth that requires a crown, one made from dental impressions taken traditionally (using putty) and one made using digital impression techniques. The fit of each crown is determined using a microscope. How well each of the crowns fit is then 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 crown 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?
Universidad Complutense de Madrid (Spain)
When is the study starting and how long is it expected to run for?
September 2010 to June 2012
Who is funding the study?
Straumann Implant system (Spain)
Who is the main contact?
Miss Cristina Zarauz
Contact information
Public
Tandheelkunde Boerhaave
Dintelstraat 60
Amsterdam
1078 VV
Netherlands
Study information
| Study design | Observational case crossover study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case crossover study |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | Clinical evaluation comparing the fit of all-ceramic crowns obtained from silicone and digital intraoral impressions |
| Study objectives | Null hypothesis: There is no difference in accuracy between the fit of the crowns fabricated with the digital impression and the conventional impression. |
| Ethics approval(s) | Comité Ético de Investigaciones Clínicas CEIC (Ethical commette for clinical investigations, Spain), 02/03/2011, ref: E-09/377 |
| Health condition(s) or problem(s) studied | Accuracy of fit of crowns fabricated by 2 different impression systems, for healthy patients. |
| Intervention | Each tooth included in the study was the investigation unit (or specimen). Each tooth was prepared for crown, and 2 impressions were taken on each tooth (one digital & one conventional). 2 crowns were produced for each tooth, one with the conventional impression, and one with the digital impression. These 2 crowns were tried on the prepared tooth, to replicate the misfit, and were left embedded in the replicated misfit, to be taken to process to the lab. Through embedding, this very thin layer of silicone (50 microns sometimes), is better stabilised. A third crown was produced by the conventional impression system (as it is still gold standard), to cement after we had done accuracy testing. Both impressions are commercially available and CE marketed and routinely employed as a standard of care. Added burden mounted to 5-10 minutes of extra chair time, as 2 impressions were taken, instead of one (impressions have no negative effect on the patient whatsoever), and later, at timepoint 2, it meant a total of 10 more minutes for the patient, as we did the accuracy testing before cementation of the final crown. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Marginal misfit of zirconia-ceramic crowns measured in micrometers between 3 and 8 days after the replication of the fit. |
| Secondary outcome measures | Internal fit of zirconia-ceramic crowns measured in micrometers between 3 and 8 days after the replication of the fit. |
| Overall study start date | 15/09/2010 |
| Completion date | 01/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 26 crowns in the 21 patients. |
| Key inclusion criteria | 1. In need of one or two (if located in contra-lateral quadrants and opposing arches) single crowns on pre-(molar) teeth 2. Subject tooth 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 | 27/01/2011 |
| Date of final enrolment | 20/03/2012 |
Locations
Countries of recruitment
- Spain
Study participating centre
Madrid
28040
Spain
Sponsor information
Industry
Edificio Arroyo - A
Avda. de Bruselas, 38 - Planta 1
Alcobendas
Madrid
28108
Spain
| Website | http://www.straumann.es/ |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/09/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The research is accepted for publication in the Journal for Clinical Oral Investigations. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2016 | Yes | No |
Editorial Notes
27/11/2015: Publication reference added.
