Orthodontic Patient Experience of Intraoral Scans Versus Alginate Impressions

NCT05194956 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2025-03-18

Study results available
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Summary

CONTEXT: Digital scanning systems are becoming more and more popular with the advent of the COVID-19 pandemic. The risks surrounding aerosol-generating procedures (AGP) has resulted in practitioners changing their normal practice and finding alternative methods to continue managing their patients. Digital (intraoral) scanners are often used to show patients treatment options and help in educating them regarding their oral hygiene as it produces an almost instant digital image of their teeth. Conventional methods using alginate impressions produce study models which are created in dental plaster or stone, involving a lab cost and a greater environmental impact but remain a popular method of recording a patient's teeth and bite.

OBJECTIVE: To investigate patient experience, operator experience and preference in intraoral scanning versus alginate impression taking in the orthodontic setting.

DESIGN, SETTING AND SUBJECTS: A randomised controlled two-period crossover trial to be conducted in a UK secondary care setting involving 84 participants ready to start orthodontic treatment, with no experience of impressions/intraoral scans in the last 2 years. Patients with cleft lip and/or palate or recent research involvement will be excluded.

OUTCOMES: A modified visual analogue scale, will be used to measure patient and operator reported outcomes (e.g. patient comfort, operator confidence, perceived time taken and induction of cough/gag reflex) following an alginate impression or an intraoral scan using Trios® 3 intraoral scanner (3Shape). The time taken for each procedure will also be measured. Lastly, operator preference will be recorded.

CONCLUSION: The proposed study aims to add to the limited evidence base, providing information regarding the use of intraoral scanners compared to alginate impressions from both the orthodontic patient and operator perspectives.

Conditions

  • Orthodontic Patient Experience

Interventions

PROCEDURE

Intraoral scan

An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen.

PROCEDURE

Alginate impressions

Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite.

Sponsors & Collaborators

  • British Orthodontic Society Foundation

    collaborator UNKNOWN
  • Derby Pump Priming Charitable Funds

    collaborator UNKNOWN
  • Derby Clinical Trials Support Unit

    collaborator UNKNOWN
  • University Hospitals of Derby and Burton NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Alison Murray, BDS, MSc, FDS RCPS, MOrth RCS · University Hospitals of Derby and Burton NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2023-01-03
Completion
2023-01-03

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05194956 on ClinicalTrials.gov