- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02364414
The Accuracy of Direct Digital Intra-oral Scanning Measurements Compared to Measurements on Study Models
The purpose of this study is to compare the accuracy of measurements derived from a commercially available direct intra-oral scanning system with those taken from plaster study models, and to compare cost implications of both systems.
The investigators will test the hypotheses:
- There is no systematic difference between measurements taken from the Trios scanner and study models.
- There is no difference in the cost of producing digital models.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Northamptonshire
-
Kettering, Northamptonshire, Storbritannia, NN16 8UZ
- Kettering General Hospital NHS Foundation Trust
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Age range 11 years old to 18 years old.
- Orthodontic patients with a range of malocclusions.
- Dentition without abnormal morphology.
- Adult/permanent dentition from the first molar to first molar in both arches.
Exclusion Criteria:
- Patients under 11 years old and over 18 years old.
- Carious teeth or teeth with significantly altered anatomy.
- Periodontal disease with significant gingival swelling.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: Cohort
Orthodontic patients, aged 11-18 who fulfill the inclusion/exclusion criteria and provide written informed consent to participate will undergo intra-oral scan.
This will be repeated 2 weeks later.
|
Direct intra-oral scan of teeth and dentition
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Measurement of tooth widths, arch lengths, overjet, overbite, crown heights and labio lingual widths
Tidsramme: Within six weeks of initial intervention
|
All dental study models, and 3D scans will have all the above measurements carried out. There are 22 patients and each will have had study models made and these will be measured twice on two separate occasions, and all scans measured twice. The measurements will be compared and analysed to see if the 3D scans accurately represent the tooth sizes and measurements that have been carried out on the dental study models (gold standard). |
Within six weeks of initial intervention
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Cost
Tidsramme: within 6 months of initial intervention
|
To determine the difference in cost between the two systems
|
within 6 months of initial intervention
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Julian O'Neill, BDS FFDRCS MOrth, Kettering General Hospital NHS Foundation Trust
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Santoro M, Galkin S, Teredesai M, Nicolay OF, Cangialosi TJ. Comparison of measurements made on digital and plaster models. Am J Orthod Dentofacial Orthop. 2003 Jul;124(1):101-5. doi: 10.1016/s0889-5406(03)00152-5.
- Han UK, Vig KW, Weintraub JA, Vig PS, Kowalski CJ. Consistency of orthodontic treatment decisions relative to diagnostic records. Am J Orthod Dentofacial Orthop. 1991 Sep;100(3):212-9. doi: 10.1016/0889-5406(91)70058-5.
- Rheude B, Sadowsky PL, Ferriera A, Jacobson A. An evaluation of the use of digital study models in orthodontic diagnosis and treatment planning. Angle Orthod. 2005 May;75(3):300-4. doi: 10.1043/0003-3219(2005)75[300:AEOTUO]2.0.CO;2.
- Fleming PS, Marinho V, Johal A. Orthodontic measurements on digital study models compared with plaster models: a systematic review. Orthod Craniofac Res. 2011 Feb;14(1):1-16. doi: 10.1111/j.1601-6343.2010.01503.x. Epub 2010 Nov 22.
- Cuperus AM, Harms MC, Rangel FA, Bronkhorst EM, Schols JG, Breuning KH. Dental models made with an intraoral scanner: a validation study. Am J Orthod Dentofacial Orthop. 2012 Sep;142(3):308-13. doi: 10.1016/j.ajodo.2012.03.031.
- Bell A, Ayoub AF, Siebert P. Assessment of the accuracy of a three-dimensional imaging system for archiving dental study models. J Orthod. 2003 Sep;30(3):219-23. doi: 10.1093/ortho/30.3.219.
- Lee SP, Delong R, Hodges JS, Hayashi K, Lee JB. Predicting first molar width using virtual models of dental arches. Clin Anat. 2008 Jan;21(1):27-32. doi: 10.1002/ca.20580.
- Machen DE. Legal aspects of orthodontic practice: risk management concepts. The diagnostic dilemma. Am J Orthod Dentofacial Orthop. 1991 Apr;99(4):381-2. doi: 10.1016/s0889-5406(05)81419-2. No abstract available.
- Tomassetti JJ, Taloumis LJ, Denny JM, Fischer JR Jr. A comparison of 3 computerized Bolton tooth-size analyses with a commonly used method. Angle Orthod. 2001 Oct;71(5):351-7. doi: 10.1043/0003-3219(2001)0712.0.CO;2.
- Zilberman O, Huggare JA, Parikakis KA. Evaluation of the validity of tooth size and arch width measurements using conventional and three-dimensional virtual orthodontic models. Angle Orthod. 2003 Jun;73(3):301-6. doi: 10.1043/0003-3219(2003)0732.0.CO;2.
- Quimby ML, Vig KW, Rashid RG, Firestone AR. The accuracy and reliability of measurements made on computer-based digital models. Angle Orthod. 2004 Jun;74(3):298-303. doi: 10.1043/0003-3219(2004)0742.0.CO;2.
- Keim RG, Gottlieb EL, Nelson AH, Vogels DS 3rd. 2008 JCO study of orthodontic diagnosis and treatment procedures, part 1: results and trends. J Clin Orthod. 2008 Nov;42(11):625-40. No abstract available.
- Mayers M, Firestone AR, Rashid R, Vig KW. Comparison of peer assessment rating (PAR) index scores of plaster and computer-based digital models. Am J Orthod Dentofacial Orthop. 2005 Oct;128(4):431-4. doi: 10.1016/j.ajodo.2004.04.035.
- Pani SC, Hedge AM. Impressions in cleft lip and palate--a novel two stage technique. J Clin Pediatr Dent. 2008 Winter;33(2):93-6.
- Sousa MV, Vasconcelos EC, Janson G, Garib D, Pinzan A. Accuracy and reproducibility of 3-dimensional digital model measurements. Am J Orthod Dentofacial Orthop. 2012 Aug;142(2):269-73. doi: 10.1016/j.ajodo.2011.12.028.
- Kachalia PR, Geissberger MJ. Dentistry a la carte: in-office CAD/CAM technology. J Calif Dent Assoc. 2010 May;38(5):323-30.
- Meyer BJ, Mormann WH, Lutz F. [Optimization of the powder application in the Cerec method with environment-friendly propellant systems]. Schweiz Monatsschr Zahnmed. 1990;100(12):1462-8. German.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- Rdb394 v6.1
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