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

NCT ID: NCT06833385

Last Updated: 2025-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pediatric Patient With Early Loss of Primary Teeth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intraoral Scanning First, PVS Impression Second

Group Type EXPERIMENTAL

Intraoral Scanning

Intervention Type 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

PVS Impression

Intervention Type 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.

PVS Impression First, Intraoral Scanning Second

Group Type EXPERIMENTAL

Intraoral Scanning

Intervention Type 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

PVS Impression

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* cooperative healthy 6-11 years old child

Exclusion Criteria

* uncooperative with experience with technique
Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Yasmine Ahmed Mortada Abd Elfatah

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yasmine Ahmed Mortada Abd Elfatah

Lecturer in Pediatric Dentistry and Dental Public Health Departme,Faculty of Dentistry, Assiut University, Assiut, Egypt.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dentistry

Asyut, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

17-2025-0002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.