Orthodontic Patient Experience of Intraoral Scans Versus Alginate Impressions

NCT05194956 | Completed Results

• 1 other identifier: UHDB/2021/022
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Orthodontic Patient; Intraoral Scan; Alginate impression; Conventional impression; Digital scan; Patient experience; Patient comfort; Preference

Outcome Measures

Primary Outcomes (1)

• Orthodontic Patient Comfort

  A 100mm modified Visual Analogue Scale (VA scale) measuring patient comfort during intraoral scanning taking versus alginate impressions taken in the orthodontic setting. A higher score would indicate a more negative experience. Minimum value: 0, Maximum value: 100

  Immediately following intervention

Secondary Outcomes (10)

• Experience of Pain

  Immediately following intervention

• Relative Speed of Impression

  Immediately following intervention

• Nausea and/or Coughing

  Immediately following intervention

• Likely Recommendation

  Immediately following intervention

• Ease of Impression for the Operator

  Immediately following intervention

Study Arms (2)

Arm 1 - Alginate impressions followed by digital intraoral scan

EXPERIMENTAL

The participant will have alginate impressions taken for orthodontic treatment records first. Followed by a digital intraoral scan a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.

Procedure: Intraoral scan; Procedure: Alginate impressions

Arm 2 - Digital intraoral scan followed by alginate impressions

EXPERIMENTAL

The participant will have a digital intraoral taken for orthodontic treatment records first. Followed by alginate impressions a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.

Procedure: Intraoral scan; Procedure: Alginate impressions

Interventions

Intraoral scan PROCEDURE

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.

Arm 1 - Alginate impressions followed by digital intraoral scan; Arm 2 - Digital intraoral scan followed by alginate impressions

Alginate impressions PROCEDURE

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.

Arm 1 - Alginate impressions followed by digital intraoral scan; Arm 2 - Digital intraoral scan followed by alginate impressions

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• New patients, aged 10 years and old, attending the Royal Derby Hospital orthodontic department, requiring study model impressions taken prior to commencing orthodontic treatment
• Participants must be capable of giving informed consent, or have an acceptable individual capable of giving consent on the patient's behalf (e.g. parent or guardian of a child under 16 years of age).

You may not qualify if:

• Patients who have had previous experience of impressions/intraoral scans in the last 2 years
• Cleft lip and/or palate patients
• Patient who have been involved in a study in the last 6 months or are currently part of a study

Sponsors & Collaborators

• University Hospitals of Derby and Burton NHS Foundation Trust: lead
• British Orthodontic Society Foundation: collaborator
• Derby Pump Priming Charitable Funds: collaborator
• Derby Clinical Trials Support Unit: collaborator

Study Sites (1)

Royal Derby Hospital

Derby, Derbyshire, DE22 3NE, United Kingdom

Location

Results Point of Contact

• Title: Mrs Trishna Patel
• Organization: University Hospitals of Derby and Burton NHS Trust

trishnaanil.patel@nhs.net

01332340131

Study Officials

• Alison Murray, BDS, MSc, FDS RCPS, MOrth RCS

  University Hospitals of Derby and Burton NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-centre prospective randomised controlled two-period crossover study

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 18, 2022
• Study Start: May 31, 2022
• Primary Completion: January 3, 2023
• Study Completion: January 3, 2023
• Last Updated: March 18, 2025
• Results First Posted: March 18, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The study data is anticipated to become available following publication. Study data will be archived for 5 years from the end of the study.
• Access Criteria: Analyses within a meta-analysis would be considered if it has been approved through an independent review committee. Requests may be submitted up to 5 years from the end of the study.

Locations

GB (1)