MalocclusionNCT03405961
A Comparison of Conventional Versus Digital PAR (Peer Assessment Rating) Scores Using an Intraoral Scanner
An observational study of Malocclusion, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion
- What is being tested?
- Carestream 3600 intra oral scan
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Oct 2018to 7 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: orthodontic patients at Kingston Hospital
Who may be able to join
- 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
Who cannot join
- patients with fixed or bonded appliances
- age <11 or >50
- Inability to gain informed consent due to communication barriers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
CS 3600 intra oral scanner is already licenced for the use in dentistry and is routinely used by some dental practitioners to substitute conventional impressions and plaster models in restorative, implant and orthodontic diagnosis and treatment planning. The scanner is 220 x 38 x 58 mm in size and operates with video capture technology. It emits no radiation.
Peer Assessment Rating (PAR) is an objective way of quantifying how severe a malocclusion is by scoring orthodontic study models. It can also be used to assess treatment outcome. All National Health Service (NHS) orthodontic providers in the United Kingdom are contractually bound to submit PAR score changes for at least 20 of their treated cases plus 10% of the remainder of their case load every year. Traditionally, PAR scoring is performed manually on plaster casts by a trained and calibrated individual. The plaster casts must be retained as part of the patient's medical records and hence consume considerable amounts of storage space. The process of manual scoring is also time intensive. Digital models 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. The purpose of this study is to assess the accuracy of PAR scores obtained from digital models with those obtained manually from conventional models for the same patient at one given point in time.
Aims: Against this background, the aim of this study is to compare digital PAR scoring using the CS 3600 intraoral scanner with conventional PAR scoring.
Objectives: The objectives are to investigate whether PAR scoring on models acquired through direct and indirect digitisation produces any significant errors when compared with conventional PAR scoring on plaster models. The study will also seek to measure the chairside time taken to produce upper and lower full arch scans and bite registration with CS 3600 versus the time taken to produce equivalent alginate impressions and wax bite. Furthermore, the time taken for digital scoring will be measured and compared with the conventional method. Finally, patient preference with regard to intraoral scans versus impressions will be investigated.
Method: The sample size was confirmed using a power calculation. The sample will consist of 66 orthodontic patients at Kingston Hospital, excluding any patients with fixed appliances or bonded components. All patients will receive conventional impressions as well as intraoral scans, serving as their own controls. Plaster casts poured from the impressions will also be scanned to produce indirect digital models. PAR scoring will then be performed by one investigator on all three models (plaster casts, direct and indirect digital models) for comparison. A second investigator will record the time taken to perform scans and impressions as well as the time taken to complete digital and conventional scoring. Immediately after the clinical procedure patients will be given a questionnaire evaluating their preference.
Data analysis: Data from the PAR scorings and questionnaires will be recorded and analysed using SPSS following consultation with a bio-statistician. The data will then be graphically represented in the form of tables and charts.
- Conditions
- Malocclusion
- Being tested
- Carestream 3600 intra oral scan
- Keywords
- PAR scoring, Digital study models
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carestream 3600 intra oral scanDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Carestream 3600 intra oral scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (5)
The length of time (in minutes) taken to obtain conventional impressions
The time taken to take conventional impressions (from insertion into the mouth until removal from the mouth) will be measured using a stop watch. The time taken to create digital impressions (from activating the scanner until completion of the scan, including any areas that need to be re-scanned) will also be measured using a stop watch.
Measured: 6 months
The length of time (in minutes) taken to obtain digital scans
The time taken to take conventional impressions (from insertion into the mouth until removal from the mouth) will be measured using a stop watch. The time taken to create digital impressions (from activating the scanner until completion of the scan, including any areas that need to be re-scanned) will also be measured using a stop watch.
Measured: 6 months
The cost involved in creating digital scans
In order to calculate the cost of conventional models, the sum of the following will be calculated: cost of impression material (the amount of impression material used will be recorded), cost of impression tray, cost of tray adhesive, disinfection cost, laboratory and transport cost.
In order to calculate the cost of digital impressions, the sum of the following will be calculated: cost of scanner and software, cost of disposable scanner tip covers
Measured: 6 months
The cost involved in creating conventional models
In order to calculate the cost of conventional models, the sum of the following will be calculated: cost of impression material (the amount of impression material used will be recorded), cost of impression tray, cost of tray adhesive, disinfection cost, laboratory and transport cost.
In order to calculate the cost of digital impressions, the sum of the following will be calculated: cost of scanner and software, cost of disposable scanner tip covers
Measured: 6 months
Do patients prefer conventional impressions or intraoral scans?
This will be assessed by means of a questionnaire consisting of 3 validated questions. The questions are designed to establish which of the two procedures the patient found 1. more comfortable, 2. quicker and 3. which they would prefer to undergo again.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start15 Oct 2018
- Primary completion15 Dec 2018
- Study completion7 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Kingston Hospital NHS Trust
- Responsible party
- Sponsor
- Investigators
- Martyn Cobourne, BDS MOrth, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405961
- Sponsor's protocol ID
- IRAS 230630
- Status last verified
- Feb 2019
- First submitted
- 18 Dec 2017
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only pseudonymised data will be shared. No patient identifiable material will be shared with other researchers.
Publications
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.
PubMed 32005465
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03405961
- Acronym / sponsor ID
- IRAS 230630
- Conditions
- Malocclusion
- Keywords
- PAR scoring, Digital study models
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Kingston Hospital NHS Trust
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 7 Jan 2019 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
CS 3600 intra oral scanner is already licenced for the use in dentistry and is routinely used by some dental practitioners to substitute conventional impressions and plaster models in restorative, implant and orthodontic diagnosis and treatment planning. The scanner is 220 x 38 x 58 mm in size and operates with video capture technology. It emits no radiation.
Peer Assessment Rating (PAR) is an objective way of quantifying how severe a malocclusion is by scoring orthodontic study models. It can also be used to assess treatment outcome. All National Health Service (NHS) orthodontic providers in the United Kingdom are contractually bound to submit PAR score changes for at least 20 of their treated cases plus 10% of the remainder of their case load every year. Traditionally, PAR scoring is performed manually on plaster casts by a trained and calibrated individual. The plaster casts must be retained as part of the patient's medical records and hence consume considerable amounts of storage space. The process of manual scoring is also time intensive. Digital models 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. The purpose of this study is to assess the accuracy of PAR scores obtained from digital models with those obtained manually from conventional models for the same patient at one given point in time.
Aims: Against this background, the aim of this study is to compare digital PAR scoring using the CS 3600 intraoral scanner with conventional PAR scoring.
Objectives: The objectives are to investigate whether PAR scoring on models acquired through direct and indirect digitisation produces any significant errors when compared with conventional PAR scoring on plaster models. The study will also seek to measure the chairside time taken to produce upper and lower full arch scans and bite registration with CS 3600 versus the time taken to produce equivalent alginate impressions and wax bite. Furthermore, the time taken for digital scoring will be measured and compared with the conventional method. Finally, patient preference with regard to intraoral scans versus impressions will be investigated.
Method: The sample size was confirmed using a power calculation. The sample will consist of 66 orthodontic patients at Kingston Hospital, excluding any patients with fixed appliances or bonded components. All patients will receive conventional impressions as well as intraoral scans, serving as their own controls. Plaster casts poured from the impressions will also be scanned to produce indirect digital models. PAR scoring will then be performed by one investigator on all three models (plaster casts, direct and indirect digital models) for comparison. A second investigator will record the time taken to perform scans and impressions as well as the time taken to complete digital and conventional scoring. Immediately after the clinical procedure patients will be given a questionnaire evaluating their preference.
Data analysis: Data from the PAR scorings and questionnaires will be recorded and analysed using SPSS following consultation with a bio-statistician. The data will then be graphically represented in the form of tables and charts.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Device: Carestream 3600 intra oral scanPatient will receive upper and lower intra-oral scans which will be PAR scored directly by the computer |
| Indirect digital PAR score | – | Device: Carestream 3600 intra oral scanPatient 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. |
Who may qualify
- Ages
- 11 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- orthodontic patients at Kingston Hospital
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- patients with fixed or bonded appliances
- age <11 or >50
- Inability to gain informed consent due to communication barriers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carestream 3600 intra oral scanCarestream 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 | Device | Direct digital PAR score, Indirect digital PAR score |
Primary outcome
Peer Assessment Rating (PAR) score
Time frame: 6 months
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.
5 secondary outcomes
The length of time (in minutes) taken to obtain conventional impressions
Time frame: 6 months
The length of time (in minutes) taken to obtain digital scans
Time frame: 6 months
The cost involved in creating digital scans
Time frame: 6 months
The cost involved in creating conventional models
Time frame: 6 months
Do patients prefer conventional impressions or intraoral scans?
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- Derived from this study: PubMed 32005465Luqmani 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.
- Individual participant dataSharing planned: No. Only pseudonymised data will be shared. No patient identifiable material will be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martyn Cobourne, BDS MOrth principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malocclusion, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peer Assessment Rating (PAR) score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03405961, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2019.