Condition category
Oral Health
Date applied
08/09/2015
Date assigned
29/09/2015
Last edited
27/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Miss Cristina Zarauz

ORCID ID

Contact details

Tandheelkunde Boerhaave
Dintelstraat 60
Amsterdam
1078 VV
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

C.I.011/170

Study information

Scientific title

Clinical evaluation comparing the fit of all-ceramic crowns obtained from silicone and digital intraoral impressions

Acronym

Study hypothesis

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

Comité Ético de Investigaciones Clínicas CEIC (Ethical commette for clinical investigations, Spain), 02/03/2011, ref: E-09/377

Study design

Observational case crossover study

Primary study design

Observational

Secondary study design

Case crossover study

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

15/09/2010

Overall trial end date

01/06/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

26 crowns in the 21 patients.

Participant 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

Recruitment start date

27/01/2011

Recruitment end date

20/03/2012

Locations

Countries of recruitment

Spain

Trial participating centre

Universidad Complutense de Madrid
Plaza de Ramón y Cajal 3
Madrid
28040
Spain

Sponsor information

Organisation

Straumann Implant system

Sponsor details

Edificio Arroyo - A
Avda. de Bruselas
38 - Planta 1
Alcobendas
Madrid
28108
Spain

Sponsor type

Industry

Website

http://www.straumann.es/

Funders

Funder type

Industry

Funder name

Straumann Implant System

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The research is accepted for publication in the Journal for Clinical Oral Investigations.

Intention to publish date

30/09/2015

Participant level data

Available on request

Results - basic reporting

Publication summary

2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26362778

Publication citations

Additional files

Editorial Notes

27/11/2015: Publication reference added.