Comparative Study Between Zirconia Crowns and Endocrowns in Pulpotomized Primary Molars

April 20, 2020 updated by: Yassmine mohamed farouk el makawi, Nahda University

Clinical Evaluation of Endocrowns Versus Prefabricated Zirconia Crowns in Pulpotomized Primary Molars : A Pilot Prospective Clinical Study

Objectives: The new approach of pediatric esthetic dentistry intended to achieve a healthy beautiful smile rather than achieving only a beautiful smile. The objective of this study was to assess the clinical performance of ceramic Endocrowns and Zirconia crowns for the restoration of pulpotomized primary molars and parental satisfaction toward these crowns. Study design: Randomized clinical trial/split mouth design compared the clinical outcomes of two coronal restorations, on patients with bilateral carious second primary molars restoring one side with Endocrown (IPS e.max Press) and the other side with zirconia crown. Children attended Nahda University; Faculty of Dentistry clinics who need restorations screened for inclusion criteria till 20 patients are recruited (20 teeth for zirconia crown restorations and 20 for Endocrowns restorations). All children fulfilled the inclusion criteria were evaluated for factors including restoration integrity, marginal adaptation, marginal discoloration, oral health and overall clinical success at 3,6,12 months while parental satisfaction at 12 months follow up..

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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
      • Cairo, Egypt, 11234
        • Yassmine Mohamed Farouk El Makawi

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. . Free of systemic diseases.
  2. Age between 4 and 7 years.
  3. Takes no medication on regular basis.
  4. Has bilateral lower second primary molar with deep carious lesion, indicated for pulp therapy and crown restoration. (split mouth)
  5. Patient and parent compliance.

Exclusion Criteria:

  • 1. Non-restorable tooth. 2. Tooth near its exfoliation. 3. Tooth with extensive root resorption or periapical pathosis.

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Endocrown
Adhesive monoblock restoration for pulpotomized primary molars
Other: Endocrowns
Adhesive monoblock restoration for pulpotomized primary molars
ACTIVE_COMPARATOR: Zirconia crowns
Prefabricated primary full coverage crown
Other: Endocrowns
Adhesive monoblock restoration for pulpotomized primary molars

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Restoration integrity
Time Frame: one year
Modified USPHS(United States Public Health Service (USPHS), alpha criteria rating system)
one year
marginal adaptation
Time Frame: one year
Modified USPHS(United States Public Health Service (USPHS), alpha criteria rating system)
one year
marginal discoloration
Time Frame: one year
Modified USPHS(United States Public Health Service (USPHS), alpha criteria rating system)
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
parent satisfaction
Time Frame: immediate after intervention
5-point Likert scale Likert scale(0-4)
immediate after intervention

Collaborators and Investigators

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

Sponsor

Nahda 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 (ACTUAL)

February 2, 2018

Primary Completion (ACTUAL)

June 3, 2018

Study Completion (ACTUAL)

July 30, 2019

Study Registration Dates

First Submitted

August 22, 2019

First Submitted That Met QC Criteria

August 28, 2019

First Posted (ACTUAL)

August 29, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 22, 2020

Last Update Submitted That Met QC Criteria

April 20, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 186

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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