- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06422611
Comparing Dental Impression Methods for Children (Digital)
May 19, 2024 updated by: Dilsah Cogulu, Ege University
Comparison of Traditional and Digital Impression Methods for Pediatric Patients in Terms of Satisfaction
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Izmir, Turkey, 35040
- Ege University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Patients who needed routine diagnostic records were included in our study.
Description
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:
- history of digital or conventional impression taking
- TMJ disorder
- Using any kind of drug that interferes pain perception
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Digital
Impression was taken with intraoral scanners
|
Both digital and conventional impressions were taken from same patients
|
|
Conventional
Impression was taken with silicone impression material
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Both digital and conventional impressions were taken from same patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessing patient preference and treatment comfort
Time Frame: March 2023-June 2023
|
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.
|
March 2023-June 2023
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 20, 2023
Primary Completion (Actual)
May 30, 2023
Study Completion (Actual)
August 20, 2023
Study Registration Dates
First Submitted
February 16, 2024
First Submitted That Met QC Criteria
May 19, 2024
First Posted (Actual)
May 21, 2024
Study Record Updates
Last Update Posted (Actual)
May 21, 2024
Last Update Submitted That Met QC Criteria
May 19, 2024
Last Verified
April 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- Ege U. Ethical Com. 23-4.1/5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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