Digital Versus Conventional Impression Techniques in Children

Not Applicable

Completed

• Conditions: Dental Impression Technique
• Interventions: Other: Digital Impression Technique; Other: Conventional Impression Technique

• Registration Number: NCT04220957
• Lead Sponsor: University of Florence

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-03
• Study First Submitted QC: 2020-01-04
• Study First Posted: 2020-01-07
• Study Start: 2021-09-11
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-13
• Last Update Posted: 2022-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Digital Impression Technique	Digital Impression Technique	Impression with an intraoral scanner (TRIOS 3, 3Shape, Denmark)
Conventional Impression Technique	Conventional Impression Technique	Conventional impression with alginate (Orthoprint, Zhermack)

Primary Outcome Measures

Name	Time	Method
Patient's preference for either digital or conventional impression techniques	30 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Comfort during impression taking	15 minutes	VAS (Visual Analogue Scale) from 0 to 10 with 0 corresponding to "very uncomfortable" and 10 corresponding to "maximum comfort"
Gag reflex during impression taking	15 minutes	VAS (Visual Analogue Scale) from 0 to 10 with 0 corresponding to "no gag reflex" and 10 corresponding to "vomiting"
Respiratory difficulty	15 minutes	VAS (Visual Analogue Scale) from 0 to 10 with 0 corresponding to "no respiratory difficulty" and 10 corresponding to "maximum respiratory difficulty"
Duration of the impression procedure	15 minutes	Time recorded in minutes
Pain during impression taking	15 minutes	VAS (Visual Analogue Scale) from 0 to 10 with 0 corresponding to "no pain" and 10 corresponding to "very painful"

Trial Locations

Locations (1)

SOD Odontostomatologia; 🇮🇹 Firenze, Italy