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Trial record 51 of 119 for:    ZIRCONIUM

Comparative Study Between Zirconia Crowns and Endocrowns in Pulpotomized Primary Molars

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ClinicalTrials.gov Identifier: NCT04073901
Recruitment Status : Completed
First Posted : August 29, 2019
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Yassmine mohamed farouk el makawi, Minia University

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 10 patients are recruited (10 teeth for zirconia crown restorations and 10 for Endocrowns restorations). All children fulfilled the inclusion criteria were evaluated for factors including crown loss, soft-tissue associated pathology, oral hygiene and overall clinical success at 6 month while ease of use and parental satisfaction were evaluated at time of placement

Condition or disease Intervention/treatment Phase
Paediatric Dentistry Other: Endocrowns Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Endocrowns Versus Prefabricated Zirconia Crowns in Pulpotomized Primary Molars : A Pilot Prospective Clinical Study
Actual Study Start Date : February 2, 2018
Actual Primary Completion Date : June 3, 2018
Actual Study Completion Date : July 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Zirconium

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




Primary Outcome Measures :
  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 Outcome Measures :
  1. parent satisfaction [ Time Frame: immediate after intervention ]
    5-point Likert scale Likert scale(0-4)



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04073901


Locations
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Egypt
Yassmine Mohamed Farouk El Makawi
Cairo, Egypt, 11234
Sponsors and Collaborators
Nahda University

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Responsible Party: Yassmine mohamed farouk el makawi, Assistant lecturer, Minia University
ClinicalTrials.gov Identifier: NCT04073901     History of Changes
Other Study ID Numbers: 186
First Posted: August 29, 2019    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yassmine mohamed farouk el makawi, Minia University:
Aesthetic
Endo-crowns
primary
molars
pulpotomy
zirconium
crowns