A Single-site Self-controlled Comparative Study of Conventional Versus Digital Peer Assessment Rating (PAR) Using the Carestream (CS) 3600 Intraoral Scanner in Orthodontic Patients
Sponsor study identifier
observational
70
1 country
1
Study Start
October 15, 2018
Actual (reported)Primary Completion
December 15, 2018
Actual (reported)Study Completion
January 7, 2019
Actual (reported)In dentistry, Peer Assessment Rating (PAR) is an objective way of quantifying how maligned a patient's teeth are by scoring orthodontic study models. It can also be used to assess treatment outcome by comparing pre- and post-treatment scores. Traditionally, PAR scoring is performed manually on plaster casts by a trained and calibrated individual. The plaster casts consume considerable amounts of storage space and the process of manual scoring can be time consuming and expensive. The recent decades have seen a rise in popularity of intra oral scanners in dentistry to produce digital study models. These obviate the need for physical storage space and a software can be used to calculate PAR scores more conveniently and at a faster speed. A review of the current literature showed that the CS 3600 intra oral scanner by Carestream Dental demonstrated acceptable accuracy for clinical use. In this study, patients will receive the usual impressions and their moulds will be PAR scored manually (usual care pathway). In addition, they will also receive intra oral scans with Carestream 3600 and the digital models will be scored by a computer. Manual and digital scores will be compared and analysed for any significant discrepancies.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 7, 2019
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 18, 2017
Actual (reported)January 23, 2018
Actual (reported)October 15, 2018
Actual (reported)December 15, 2018
Actual (reported)January 7, 2019
Actual (reported)Peer Assessment Rating (PAR) score
PAR score is an objective and standardised way of quantifying how much the position of teeth deviate from an ideal. Sub-scores are given in 5 categories assessing the position of teeth to adjacent teeth in same jaw as well as the opposing jaw. The sub scores are weighted according to their importance as described by Richmond et al. (1992) and then added to give a total score. Total scores may range from 2 to approximately 50. The higher the score, the greater the deviation from ideal.
6 months
The length of time (in minutes) taken to obtain conventional impressions
6 months
The length of time (in minutes) taken to obtain digital scans
6 months
The cost involved in creating digital scans
6 months
The cost involved in creating conventional models
6 months
Do patients prefer conventional impressions or intraoral scans?
6 months
Patient will receive upper and lower impressions, which will be cast to produce plaster models. A calibrated individual will PAR score the casts in the traditional manner (regular care pathway)
Patient will receive upper and lower intra-oral scans which will be PAR scored directly by the computer
Patient will receive upper and lower impressions which will be cast to produce plater models (regular care pathway). The casts will be scanned with Carestream 3600 intra oral scanner and scored digitally by the computer.
Carestream 3600 is CE marked intra oral scanner manufactured by Carestream Dental. It is already licensed for use in dentistry to produce digital study models. The scanner is 220 x 38 x 58 mm large and operates using video capture technology. It emits no radiation. Carestream 3600 is connected to a computer via a USB port and a computer software (CS Model +) converts the scan into digital study models using trigonometric calculations. The software is then used to take measurements on the digital models and calculate PAR scores
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
orthodontic patients at Kingston Hospital
Kingston Hospital
Kingston upon Thames, United Kingdom
Luqmani S, Jones A, Andiappan M, Cobourne MT. A comparison of conventional vs automated digital Peer Assessment Rating scoring using the Carestream 3600 scanner and CS Model+ software system: A randomized controlled trial. Am J Orthod Dentofacial Orthop. 2020 Feb;157(2):148-155.e1. doi: 10.1016/j.ajodo.2019.10.011.
Martyn Cobourne, BDS MOrth
King's College London
70 participants (actual enrollment reported by the registry).
First Submitted
December 18, 2017
First Posted
January 23, 2018
Study Start
October 15, 2018
Actual (reported)Artificial Intelligence (AI) Empowered Smile Simulations: Do They Accurately Predict Actual Post Treatment Outcomes
Contact the study team to confirm eligibility.
Primary Completion
December 15, 2018
Actual (reported)Study Completion
January 7, 2019
Actual (reported)Last Updated
March 1, 2019
Record last verified: 2019-02
Only pseudonymised data will be shared. No patient identifiable material will be shared with other researchers.
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Source: ClinicalTrials.gov.
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