Digital Analysis of Primary Teeth Crown Dimensions and Clinical Evaluation in a Sample of Egyptian Children (Digital Analys)

March 8, 2025 updated by: Reham Abdelwahed Melegy, Tanta University

The aim of this study will be conducted to:

  1. Digitally determine crown dimensions of primary teeth in a sample of Egyptian children.
  2. Clinical evaluation of prefabricated zirconia crowns according to the Egyptian sizes compared with the international standard zirconia crowns sizes for primary upper central incisors

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Currently, there is limited availability of primary tooth crown measurement for Egyptian children. SO, this study aims to digitally determine tooth crown dimensions of primary teeth in a group of Egyptian children and compare prefabricated zirconia crowns according to the Egyptian crown sizes with the international standard zirconia crowns sizes for primary upper central incisors.

Study Type

Interventional

Enrollment (Estimated)

59

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 Contact

Study Contact Backup

Study Locations

  • Egypt
      • Tanta, Egypt
        • Tanta University

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:

  • Children having normal fully erupted primary teeth and with no morphological variations.
  • Children with no history of orthodontic or prosthodontic treatment.
  • Children with normal overjet and overbite.
  • Sound interproximal & buccal / lingual walls with or without minimal occlusal pits & fissure incipient caries.
  • No previous interproximal & buccal / lingual restorations.
  • Intact mesial and distal marginal ridge.

Exclusion Criteria:

  • Children with gross carious lesions.
  • Children with hypo-mineralization, hypoplasia and fracture primary teeth.
  • Children with medical disabilities

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: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Primary Teeth Crown Dimensions in a Sample of Egyptian Children
Digitally determine crown dimensions of primary teeth in a sample of Egyptian children
Device: prefabricated CAD-CAM Zirconia crowns according to Egyptian sizes.
compare prefabricated zirconia crowns according to the Egyptian crown sizes with the international standard zirconia crowns sizes for primary upper central incisors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
crown dimensions of primary teeth in a sample of Egyptian children.
Time Frame: intra operative
Digitally determine crown dimensions of primary teeth in a sample of Egyptian children using intraoral scanner and Digital measurements of teeth dimensions by Meshmixer analyzing software.
intra operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical evaluation of prefabricated zirconia crowns according to the Egyptian sizes compared with the international standard zirconia crowns sizes for primary upper central incisors.
Time Frame: intra operative
Clinical evaluation of prefabricated zirconia crowns according to the Egyptian sizes compared with the international standard zirconia crowns sizes for primary upper central incisors by Modified United States Public Health Service (USPHS) criteria, and the gingival state near the primary performed crown will be assessed by using the Silness& Loe indices (1964) to record plaque index and gingival index.
intra operative

Collaborators and Investigators

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

Sponsor

Tanta University

Investigators

  • Principal Investigator: Reham Abdelwahed Melegy, MSC, Tanta University

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 (Estimated)

April 1, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

March 8, 2025

First Submitted That Met QC Criteria

March 8, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 8, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Digital Analysis of teeth
  • PED1-252299 (Registry Identifier: Research Ethics Committee Faculty of Dentistry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

for patient privacy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Subscribe