Digital Versus Conventional Impression Techniques in Children
Condition: Dental Impression Technique
Study type: Interventional

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.
    


Intervention name(s): Digital Impression Technique; Conventional Impression Technique
Intervention type(s): Other; Other
Intervention description(s): 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.; Conventional Impression Technique of both arches will be taken with alginate (Orthoprint, Zhermack) on conventional stainless steel impression trays.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic