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N/A N=86 Randomized Single-blind Treatment

Orthodontic Patient Experience of Intraoral Scans Versus Alginate Impressions

Orthodontic Patient Experience

Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Orthodontic Patient Comfort — 9.2; 7.7 score on a scale — p=0.0006

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Intraoral scan (Procedure); Alginate impressions (Procedure)
Age
Pediatric, Adult, Older Adult · 10+ yrs
Sex
All
Sponsor
University Hospitals of Derby and Burton NHS Foundation Trust
Primary completion
Jan 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Orthodontic Patient Comfort
9.2; 7.7 0.0006 sig
SECONDARY
Experience of Pain
-3.5; -3.3 0.1230
SECONDARY
Relative Speed of Impression
-3.5; -3.4 0.0439 sig
SECONDARY
Nausea and/or Coughing
12.6; 6.7 0.0213 sig
SECONDARY
Likely Recommendation
6.4; 4.1 0.0146 sig
SECONDARY
Ease of Impression for the Operator
-1.6; -8.8 0.0817
SECONDARY
Confidence Taking the Impression for the Operator
-1.9; -2.6 0.1347
SECONDARY
Relative Speed of Impression for the Operator
-8.1; -14.2 0.0200 sig
SECONDARY
Operator Experience of Sickness or Coughing
-26.9; -19.6 <0.00005 sig
SECONDARY
Chairside Time Taken to Complete Impression Method
-88.8; -151.1 <0.00005 sig
SECONDARY
Operator Preference
3; 1

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.

Eligibility Criteria

Inclusion Criteria

  • 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).

Exclusion Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05194956). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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