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Clinical Trials/NCT04073901
NCT04073901
Completed
Not Applicable

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

Nahda University1 site in 1 country20 target enrollmentFebruary 2, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Paediatric
Sponsor
Nahda University
Enrollment
20
Locations
1
Primary Endpoint
marginal adaptation
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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..

Registry
clinicaltrials.gov
Start Date
February 2, 2018
End Date
July 30, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yassmine mohamed farouk el makawi

Assistant lecturer

Minia University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

marginal adaptation

Time Frame: one year

Modified USPHS(United States Public Health Service (USPHS), alpha criteria rating system)

marginal discoloration

Time Frame: one year

Modified USPHS(United States Public Health Service (USPHS), alpha criteria rating system)

Restoration integrity

Time Frame: one year

Modified USPHS(United States Public Health Service (USPHS), alpha criteria rating system)

Secondary Outcomes

  • parent satisfaction(immediate after intervention)

Study Sites (1)

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