Time and Cost-implications of Intraoral Scans Vs Alginate Impressions

NCT06345989 | Not Yet Recruiting

• 2 other identifiers: 187157340246
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND: Alginate impressions have long been a staple in orthodontics, but with recent technological advancements, digital impressions via intraoral scans are gaining increasing popularity. While much research has focused on patient preference and the accuracy of these techniques, there is a notable gap in the literature regarding chair side time and associated costs. Existing studies on chair side time comparisons between alginate impressions and intraoral scanning yield inconsistent results, underscoring the need for further investigation. This study aimed to evaluate the chair side time and cost implications of intraoral scanning and alginate impressions. OBJECTIVES: The primary objective is to compare the chair side time taken for alginate impressions and intraoral scanning of orthodontic patients aged 9 years and over in an orthodontic department at a district general hospital. The secondary objective is to evaluate the costs associated with alginate impressions and intraoral scanning of orthodontic patients described above. DESIGN, SETTING AND PARTICIPANTS: A prospective, single-centre, parallel-arm randomised controlled trial (1:1 allocation) to be undertaken in a district general hospital. Sixty-eight orthodontic patients aged nine and above, requiring study models, will be recruited during new patient appointments at the Orthodontic Department at Queen's Medical Centre, Nottingham. Patients will be randomly assigned to either the intraoral scan or alginate impression group, with chair side time recorded for each procedure, including retakes. The IOS group will use the 3Shape TRIOS scanner, while the alginate group will follow standard procedures. The costs of each technique will be calculated following the procedure. Ethical approval was obtained from a Health Research Authority Research Ethics Committee. OUTCOMES: N/A CONCLUSIONS: N/A

Conditions

Alginate Impression; Intraoral Scanner; Time; Cost

Keywords

Orthodontics; Alginate; Impression; Intraoral; Scanner

Outcome Measures

Primary Outcomes (1)

• Chairside time taken for alginate impressions vs intraoral scans.

  To compare the mean chairside time taken for alginate impression taking and intraoral scanning of orthodontic patients aged 9 years and over, in an orthodontic department at a district general hospital.

  12 months

Secondary Outcomes (1)

• Cost implications of alginate impressions vs intraoral scans.

  12 months

Study Arms (2)

Alginate impression

ACTIVE COMPARATOR

Alginate impression

Procedure: Alginate impression

Intraoral scan

ACTIVE COMPARATOR

Intraoral scan using Trios 3Shape Scanner

Procedure: Intraoral scan

Interventions

Alginate impression PROCEDURE

Alginate impressions are a traditional method for creating dental moulds which are used in orthodontic records. Plastic trays are sized to fit the upper and lower jaws, and the alginate is mixed into a putty before being placed in the trays. The putty is then used to take detailed impressions of the patient's teeth. To capture an accurate bite registration, the patient bites down on a piece of warmed wax.

Alginate impression

Intraoral scan PROCEDURE

Intraoral scanners capture multiple images of the mouth, which are combined to create a three-dimensional model of the patient's upper and lower teeth. The scanning wand is passed methodically over the surface of the teeth to gather all the necessary information, which is displayed in real-time on a computer screen.

Intraoral scan

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Orthodontic patients aged 9 years and above requiring study models, having attended the orthodontic department at Nottingham University Hospitals for a new patient assessment.

You may not qualify if:

• Patients who will not be undergoing orthodontic treatment in secondary care (referral back to primary care).
• Patients with contraindications to either impression method (e.g., severe gag reflex, claustrophobia, medical history that would preclude the taking of dental impressions).
• Patients with severe dental anxiety.
• Patients with cleft lip and/or palate.

Sponsors & Collaborators

• University of Sheffield: lead
• Nottingham University Hospitals NHS Trust: collaborator

Study Sites (1)

Queens Medical Centre, Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Related Publications (11)

• Bosoni C, Nieri M, Franceschi D, Souki BQ, Franchi L, Giuntini V. Comparison between digital and conventional impression techniques in children on preference, time and comfort: A crossover randomized controlled trial. Orthod Craniofac Res. 2023 Nov;26(4):585-590. doi: 10.1111/ocr.12648. Epub 2023 Mar 20.

  PMID: 36891891 BACKGROUND

• Burhardt L, Livas C, Kerdijk W, van der Meer WJ, Ren Y. Treatment comfort, time perception, and preference for conventional and digital impression techniques: A comparative study in young patients. Am J Orthod Dentofacial Orthop. 2016 Aug;150(2):261-7. doi: 10.1016/j.ajodo.2015.12.027.

  PMID: 27476358 BACKGROUND

• Burzynski JA, Firestone AR, Beck FM, Fields HW Jr, Deguchi T. Comparison of digital intraoral scanners and alginate impressions: Time and patient satisfaction. Am J Orthod Dentofacial Orthop. 2018 Apr;153(4):534-541. doi: 10.1016/j.ajodo.2017.08.017.

  PMID: 29602345 BACKGROUND

• Christopoulou I, Kaklamanos EG, Makrygiannakis MA, Bitsanis I, Tsolakis AI. Patient-reported experiences and preferences with intraoral scanners: a systematic review. Eur J Orthod. 2022 Jan 25;44(1):56-65. doi: 10.1093/ejo/cjab027.

  PMID: 34089258 BACKGROUND

• Glisic O, Hoejbjerre L, Sonnesen L. A comparison of patient experience, chair-side time, accuracy of dental arch measurements and costs of acquisition of dental models. Angle Orthod. 2019 Nov;89(6):868-875. doi: 10.2319/020619-84.1. Epub 2019 Jul 1.

  PMID: 31259615 BACKGROUND

• Grunheid T, McCarthy SD, Larson BE. Clinical use of a direct chairside oral scanner: an assessment of accuracy, time, and patient acceptance. Am J Orthod Dentofacial Orthop. 2014 Nov;146(5):673-82. doi: 10.1016/j.ajodo.2014.07.023. Epub 2014 Oct 28.

  PMID: 25439218 BACKGROUND

• 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.

  PMID: 32005465 BACKGROUND

• Mangano A, Beretta M, Luongo G, Mangano C, Mangano F. Conventional Vs Digital Impressions: Acceptability, Treatment Comfort and Stress Among Young Orthodontic Patients. Open Dent J. 2018 Jan 31;12:118-124. doi: 10.2174/1874210601812010118. eCollection 2018.

  PMID: 29492177 BACKGROUND

• Mangano F, Gandolfi A, Luongo G, Logozzo S. Intraoral scanners in dentistry: a review of the current literature. BMC Oral Health. 2017 Dec 12;17(1):149. doi: 10.1186/s12903-017-0442-x.

  PMID: 29233132 BACKGROUND

• Sivaramakrishnan G, Alsobaiei M, Sridharan K. Patient preference and operating time for digital versus conventional impressions: a network meta-analysis. Aust Dent J. 2020 Mar;65(1):58-69. doi: 10.1111/adj.12737. Epub 2019 Dec 19.

  PMID: 31749234 BACKGROUND

• Yilmaz H, Aydin MN. Digital versus conventional impression method in children: Comfort, preference and time. Int J Paediatr Dent. 2019 Nov;29(6):728-735. doi: 10.1111/ipd.12566. Epub 2019 Aug 13.

  PMID: 31348834 BACKGROUND

Study Officials

• Norah Flannigan

  University of Sheffield

  STUDY CHAIR

Central Study Contacts

Miss H Hook, BDS

CONTACT

0115 924 9924; hannah_hook@outlook.com

Andrew Flett

CONTACT

andrewflett1@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the study, blinding to intervention will not be possible for the participants or clinicians during data acquisition. All data analysis will be carried out blinded using a coded data set.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective single-centre parallel arm randomised controlled trial, with an allocation ratio of 1:1 to investigate the difference in chairside time and cost of alginate impressions vs intraoral scans.

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 3, 2024
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 5, 2025

Record last verified: 2024-12

Locations

GB (1)