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

NCT06833385 | Active Not Recruiting

• 1 other identifier: 17-2025-0002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Patient With Early Loss of Primary Teeth

Outcome Measures

Primary Outcomes (1)

• Patient Preference for Impression Technique

  Immediately after the second impression (within the same visit)

Study Arms (2)

Intraoral Scanning First, PVS Impression Second

EXPERIMENTAL

Diagnostic Test: Intraoral Scanning; Diagnostic Test: PVS Impression

PVS Impression First, Intraoral Scanning Second

EXPERIMENTAL

Diagnostic Test: Intraoral Scanning; Diagnostic Test: PVS Impression

Interventions

Intraoral Scanning DIAGNOSTIC_TEST

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

Intraoral Scanning First, PVS Impression Second; PVS Impression First, Intraoral Scanning Second

PVS Impression DIAGNOSTIC_TEST

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.

Intraoral Scanning First, PVS Impression Second; PVS Impression First, Intraoral Scanning Second

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• cooperative healthy 6-11 years old child

You may not qualify if:

• uncooperative with experience with technique

Sponsors & Collaborators

• Yasmine Ahmed Mortada Abd Elfatah: lead

Study Sites (1)

Dentistry

Asyut, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer in Pediatric Dentistry and Dental Public Health Departme,Faculty of Dentistry, Assiut University, Assiut, Egypt.

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 18, 2025
• Study Start: February 1, 2025
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)