Digital Versus Conventional Impression Techniques in Children

NCT04220957 | Completed

• 1 other identifier: LF8
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The impression is a necessary step for the orthodontic diagnosis. Digital impression has recently been introduced by means of intraoral optical scanners. To date, few studies have compared the conventional alginate impression with the digital impression with intraoral scanners. These studies have shown that digital impression could have some advantages in terms of satisfaction and less discomfort for the pediatric patient. Only one study is randomized and has analyzed patients between 10 and 17 years of age. There are, therefore, no randomized trials for patients under 10 years of age. The objective of the study is to compare the conventional alginate impression with the digital impression of both dental arches in orthodontic patients between 6 and 10 years of age with a randomized crossover design. In particular, the preference, comfort, impression taking time and other subjective aspects will be analyzed. This is a monocentric, controlled, superiority, randomized, crossover, open study. Inclusion criteria: \- Orthodontic patients between 6 and 10 years of age. Exclusion criteria:

• Noncompliant patients
• patients with syndromes or systemic diseases
• patients suffering from cleft lip and palate. The patient will be asked which of the 2 dental arch impression procedures they prefer. In addition, patients will be provided with a questionnaire including VAS (Visual Analogue Scale) for comfort, pain, gag reflex and breathing difficulty. The VAS will consist of scales from 0 to 10. As for the calculation of the sample size, this has been done by considering a null hypothesis for a proportion of 50% in the preference between the two treatments and an alternative hypothesis of 80%. For alpha set at 0.05, a power of 80% and a dropout rate of 10%, 24 patients are required. Descriptive statistics will be performed for all variables (frequency and percentage for qualitative variables and mean and standard deviation for quantitative variables). For the primary endpoint variable, impression procedure preference, the test will be performed for one proportion and the 95% confidence interval will be calculated using the Clopper-Pearson method. With regard to the secondary endpoint variables, duration of the procedure, comfort, pain, gag reflex, breathing difficulty, the 2 procedures will be compared with the t-test for paired data. An Intention-To-Treat analysis will be performed. In case more than 5 deviations from the protocol will occur, a sensitivity analysis will also be performed per protocol.

Conditions

Dental Impression Technique

Outcome Measures

Primary Outcomes (1)

• Patient's preference for either digital or conventional impression techniques

  The patient will be asked "If you had to take another impression which one of the 2 impression techniques would you prefer?" The patient will mark on a sheet of paper which one of the 2 impression techniques he/she prefers.

  30 minutes

Secondary Outcomes (5)

• Comfort during impression taking

  15 minutes

• Pain during impression taking

  15 minutes

• Gag reflex during impression taking

  15 minutes

• Respiratory difficulty

  15 minutes

• Duration of the impression procedure

  15 minutes

Study Arms (2)

Digital Impression Technique

EXPERIMENTAL

Impression with an intraoral scanner (TRIOS 3, 3Shape, Denmark)

Other: Digital Impression Technique

Conventional Impression Technique

ACTIVE COMPARATOR

Conventional impression with alginate (Orthoprint, Zhermack)

Other: Conventional Impression Technique

Interventions

Digital Impression Technique OTHER

Digital impressions of both arches will be taken by using an intraoral scanner (Trios 3, 3Shape, Denmark) by adhering to the scanning pattern recommended by the company for routine diagnosis and recording.

Digital Impression Technique

Conventional Impression Technique OTHER

Conventional Impression Technique of both arches will be taken with alginate (Orthoprint, Zhermack) on conventional stainless steel impression trays.

Conventional Impression Technique

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Orthodontic patients between 6 and 10 years of age.

You may not qualify if:

• Noncompliant patients
• patients with syndromes or systemic diseases
• patients suffering from cleft lip and palate.

Sponsors & Collaborators

• University of Florence: lead

Study Sites (1)

SOD Odontostomatologia

Florence, 50127, Italy

Location

Related Publications (1)

• 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 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professsor

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: January 7, 2020
• Study Start: September 11, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: May 19, 2022

Record last verified: 2022-05

Locations

IT (1)