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CompletedNCT06422611DigitalUpdated May 21, 2024

Comparing Dental Impression Methods for Children

An observational study in Dental Impression, Pediatric Dentistry, Satisfaction, sponsored by Ege University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 7 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-21.

Sponsored by Ege University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
60
Ages
7 Years to 12 Years
Sex
All
01

Study summary

The precision of dental restorations and the production of dental models has improved due to the acceleration of technical advancement and the introduction of computer-aided manufacturing.

The study's objective is to compare the conventional imprint approach with a digital one in order to compare patients' comfort levels, preferences, and treatment times among pediatric patients.

Read the detailed description

In this study, 60 volunteers without any prior exposure to traditional or digital impressions took part. Using a C-type impression medium, conventional impressions of the maxillary and mandibular dental arches were taken. Digital impressions are taken using an intra-oral scanner at the same appointment. Following the impressions, a standardized questionnaire was used to assess the individuals' attitudes, preferences, and perceptions of the impression procedures. The Wong-Baker Pain Rating Scale was used to assess the perceived source of stress and Frankl Behavioural Scale was used for assessing behaviour. After taking the impression, the processing phases of the impression techniques (working time, etc.), and parental satisfaction were noted.

02

Conditions studied

  • Dental Impression, Pediatric Dentistry, Satisfaction

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03

In context

Personal Satisfaction

143 studies on the registry are indexed under Personal Satisfaction; 50 are open to participants now.

This study's enrollment of 60 is below the median of 120 across 23 observational studies indexed under Personal Satisfaction.

Browse Personal Satisfaction studies →

Lead sponsor

Ege University is the lead sponsor of 375 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients who needed routine diagnostic records were included in our study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • not to have a history of digital or conventional impression taking
  • not to have temporomandibular joint and periodontal discomfort
  • not to be using psychiatric or neuropathic drugs

Exclusion criteria

Exclusion Criteria:

  • history of digital or conventional impression taking
  • TMJ disorder
  • Using any kind of drug that interferes pain perception
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • Digital

    Impression was taken with intraoral scanners

    Device: Impression methods

  • Conventional

    Impression was taken with silicone impression material

    Device: Impression methods

Interventions

  • DeviceImpression methods

    Both digital and conventional impressions were taken from same patients

06

What researchers measure

Primary outcomes

  1. Assessing patient preference and treatment comfort

    Parental satisfaction was measured with a structured questionnaire.The Wong-Baker Pain Rating Scale was used to assess the perceived source of stress and Frankl Behavioural Scale was used for assessing behaviour. A survey was designed to test 3 areas of patient satisfaction regarding the impression experience: comfort, time, and novelty. The survey consisted of 7 statements with a 100-mm visual analog scale (VAS) below each statement anchored with "agree" and "disagree." The survey also included questions to determine whether the patient had previous experience with impressions.

    Time frame: March 2023-June 2023

07

Study locations

1 site
  • Ege University
    Izmir, 35040, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2023 to primary completion in May 2023, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 16, 2024
First posted
May 21, 2024
StartActual
Apr 20, 2023
Primary completionActual
May 30, 2023
CompletionActual
Aug 20, 2023
Last update
May 21, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06422611
Lead sponsor
Ege University
Responsible party
Dilsah Cogulu (Professsor, Ege University) — Principal investigator
First posted
May 21, 2024
Start date
Apr 20, 2023
Primary completion
May 30, 2023
Completion
Aug 20, 2023
Last update
May 21, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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