Comparative Evaluation of Pediatric Patient Comfort, Time, and Preference Between Digital Scans and Rubber Base Impressions. Crossover Study Randomized Controlled Trial

February 13, 2025 updated by: Yasmine Ahmed Mortada Abd Elfatah
The comfort of impression methods and the time they require are important because it is known that children are more stressed in their encounter with the dentist than the elderly, and their chairside times are shorter. The comparison of impression methods in terms of comfort, preference, and time has been studied only in young adults or adult patients. thus this study will assess pediatric patient comfort, time, and preference between digital scans and rubber base impressions.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

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

  • Egypt
      • Assiut, Egypt
        • Dentistry

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

No

Description

Inclusion Criteria:

  • cooperative healthy 6-11 years old child

Exclusion Criteria:

  • uncooperative with experience with technique

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intraoral Scanning First, PVS Impression Second
Diagnostic test: Intraoral Scanning
Participants will first undergo intraoral scanning using a digital scanner to capture a 3D image of their dental arches. The procedure is non-invasive and requires no impression material. After one week, the same participants will undergo a polyvinyl siloxane (PVS) impression using conventional impression trays and materials
Diagnostic test: PVS Impression
Participants will first undergo a polyvinyl siloxane (PVS) impression, where an impression tray filled with PVS material is used to capture the shape of their dental arches. After one week, the same participants will undergo intraoral scanning using a digital scanner for a 3D image of their dentition.
Experimental: PVS Impression First, Intraoral Scanning Second
Diagnostic test: Intraoral Scanning
Participants will first undergo intraoral scanning using a digital scanner to capture a 3D image of their dental arches. The procedure is non-invasive and requires no impression material. After one week, the same participants will undergo a polyvinyl siloxane (PVS) impression using conventional impression trays and materials
Diagnostic test: PVS Impression
Participants will first undergo a polyvinyl siloxane (PVS) impression, where an impression tray filled with PVS material is used to capture the shape of their dental arches. After one week, the same participants will undergo intraoral scanning using a digital scanner for a 3D image of their dentition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient Preference for Impression Technique
Time Frame: Immediately after the second impression (within the same visit)
Immediately after the second impression (within the same visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yasmine Ahmed Mortada Abd Elfatah

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)

February 1, 2025

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

February 13, 2025

First Submitted That Met QC Criteria

February 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 13, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 17-2025-0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to patient confidentiality concerns and ethical considerations. The collected data is specific to the study objectives and not intended for

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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