NCT03405961

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

October 15, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2018

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2019

Completed
Last Updated

March 1, 2019

Status Verified

February 1, 2019

Enrollment Period

2 months

First QC Date

December 18, 2017

Last Update Submit

February 28, 2019

Conditions

Keywords

PAR scoringDigital study models

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • 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

Study Arms (3)

Manual PAR score

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)

Direct digital PAR score

Patient will receive upper and lower intra-oral scans which will be PAR scored directly by the computer

Device: Carestream 3600 intra oral scan

Indirect digital PAR score

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.

Device: Carestream 3600 intra oral scan

Interventions

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

Direct digital PAR scoreIndirect digital PAR score

Eligibility Criteria

Age11 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

orthodontic patients at Kingston Hospital

You may qualify if:

  • Patients undergoing orthodontic treatment at Kingston Hospital
  • Patients who have completed their orthodontic treatment and are attending for retainer reviews at Kingston Hospital
  • age 11-50

You may not qualify if:

  • patients with fixed or bonded appliances
  • age \<11 or \>50
  • Inability to gain informed consent due to communication barriers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kingston Hospital

Kingston upon Thames, United Kingdom

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Martyn Cobourne, BDS MOrth

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2017

First Posted

January 23, 2018

Study Start

October 15, 2018

Primary Completion

December 15, 2018

Study Completion

January 7, 2019

Last Updated

March 1, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Only pseudonymised data will be shared. No patient identifiable material will be shared with other researchers.

Locations