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OpenTrials
Completed

NCT Number: NCT04073901

Comparative Study Between Zirconia Crowns and Endocrowns in Pulpotomized Primary Molars

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..

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Key information

Conditions

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yassmine Mohamed Farouk El Makawi

Cairo, 11234, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Endocrowns

Other

Adhesive monoblock restoration for pulpotomized primary molars

Primary outcomes

  1. Restoration integrity

    Time frame: one year

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

  2. marginal adaptation

    Time frame: one year

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

  3. marginal discoloration

    Time frame: one year

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

Secondary outcomes

  1. parent satisfaction

    Time frame: immediate after intervention

    5-point Likert scale Likert scale(0-4)

Sponsors and collaborators

Lead sponsor

Nahda University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Aug 29, 2019
Registry last updated
Apr 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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