Primary Molars Restoration Using Different Pediatric Crowns.

May 10, 2025 updated by: Nehal Salman

CAD/CAM Crowns Versus Prefabricated Zirconia and Stainless Steel Crowns for Restoration of Primary Molars: A Prospective Study.

study aims to compare hybrid ceramic CAD/CAM and prefabricated zirconia ans stainless steel crowns restoring primary molars through In-vivo evaluation of the clinical outcomes in terms of; crown retention, stain resistance and periodontal and gingival health as well as parental/child satisfaction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

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
      • Alexandria, Egypt, 21648
        • Nehal Salman

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

4 years to 7 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age range of the patients from 5 to 8 years old.
  2. Have no history of spontaneous pain or swelling.
  3. Patients willing to return for follow-up examinations and evaluation.
  4. Medically free patients or with controlled systemic disease ASA I or II.
  5. No active periodontal diseases.
  6. Patients with posterior pulpotomized tooth/teeth indicated for crown restoration (e.g. 2-3mm of teeth above cement-enamel junction).

Exclusion Criteria:

  1. Children with intellectual, severe emotional or behavioral problems.
  2. Presence of parafunctional habits such as clenching or bruxism.
  3. Abnormal tooth mobility, gingival swelling, fistulous tract, or non-vital pulps.
  4. Non-restorable teeth.
  5. Radiographic positive signs of thickened or interrupted periodontal membrane space, internal root resorption, periapical or furcal radiolucency

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Zirconia crowns
Other: CAD/CAM crowns
CAD/CAM crowns
Active Comparator: CAD/CAM crowns
Other: CAD/CAM crowns
CAD/CAM crowns
Active Comparator: Stainless-steel crowns
Other: CAD/CAM crowns
CAD/CAM crowns

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical success
Time Frame: 1 year
United States Public Health Service (USPHS) index
1 year

Collaborators and Investigators

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

Sponsor

Nehal Salman

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)

November 25, 2021

Primary Completion (Actual)

November 25, 2022

Study Completion (Actual)

November 25, 2022

Study Registration Dates

First Submitted

October 28, 2019

First Submitted That Met QC Criteria

October 28, 2019

First Posted (Actual)

October 30, 2019

Study Record Updates

Last Update Posted (Actual)

May 14, 2025

Last Update Submitted That Met QC Criteria

May 10, 2025

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 318

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.

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