An interventional study of Intraoral scanner and Alginate impression in Dental Anxiety, sponsored by Hams Hamed Abdelrahman. Recruiting at 1 site in Egypt. Open to participants aged 4 Years to 6 Years. Per ClinicalTrials.gov, last updated 2024-10-02.
Sponsored by Hams Hamed Abdelrahman · Not applicable, Interventional, and Other
Background: Taking alginate impressions for preschoolers is challenging and might be disturbing for them. Therefore, intraoral scanners are suggested as a better alternative to the conventional alginate impression.
Objectives: The present study aims to evaluate and compare the level of patients' discomfort, dental anxiety, gag reflex, behavior and time required for taking alginate impressions with that of intraoral scanning.
Materials and methods: The study will be a randomized, controlled clinical trial, parallel design. A total of 666 pediatric dental patients aged from 4-6 years will be selected from the outpatient clinic of the of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University. Participants will be allocated into 2 groups. Children in the first group will receive digital impressions by an intraoral scanner, while those of the second group will receive conventional alginate impressions. Patients' discomfort will be evaluated by a modified VAS index supported with emojis. Dental anxiety will be evaluated using Facial Image Scale (FIS). Gag reflex will be assessed by Gag Severity Index (GSI). Child's behavior towards the impression technique in the 2 groups will be evaluated using Venham's Behavior rating scale. Time taken to complete the procedures will be recorded using a digital stopwatch.
Hams Hamed Abdelrahman is the lead sponsor of 111 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Other: Intraoral scanner
Other: Alginate impression
* The digital impressions will be made with the intraoral scanner following the procedure reported by the manufacturer. * The intraoral scanning process is divided into the lower jaw scan, upper jaw scan, and bite scan stages
Conventional impressions of both arches will be made according to the manufacturer's instructions, using steel impression trays and alginate
Change in child discomfort
Children's discomfort will be evaluated using a 100-mm modified VAS index supported with facial emojis.
Time frame: intraoperative
Change in dental anxiety
Dental anxiety will be recorded using the Facial Image Scale (FIS) Children will be asked to indicate which of the faces they feel most like at that moment, it is a 'state' measure of anxiety that provides an immediate reflection of how the child is feeling.
Time frame: intraoperative
Gag reflex
After taking the impressions, child's gag reflex will be assessed. Gag sensitivity is ranked on a scale from 1 (least severe) to 5 (most severe) using the Gagging Severity Index (GSI)
Time frame: post procedure
Assessment of level of child cooperation
Venham's Behavior rating scale classifies the child's behavior into 6 categories with scores ranging from 0 to 5. A score of 0 means total cooperation and a score of 5 refers to complete absence of compliance and cooperation and the requirement of physical restraint
Time frame: intraoperative
procedure time
Time taken from scanning and taking impression for the lower and upper jaws to the final bite registeration. Time will be recorded in minutes
Time frame: intraoperative
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