Comparative Study Between Zirconia Crowns and Endocrowns in Pulpotomized Primary Molars

Dentistry Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04073901
• Other study ID #: 186
• Status: Completed
• Phase: N/A
• Start date: February 2, 2018
• Est. completion date: July 30, 2019

Study information

• Verified date: April 2020
• Source: Nahda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 30, 2019
• Est. primary completion date: June 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dentistry
• Paediatric

Intervention

Other:
• Endocrowns
Adhesive monoblock restoration for pulpotomized primary molars

Locations

Country	Name	City	State
Egypt	Yassmine Mohamed Farouk El Makawi	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Nahda University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Restoration integrity	Modified USPHS(United States Public Health Service (USPHS), alpha criteria rating system)	one year
Primary	marginal adaptation	Modified USPHS(United States Public Health Service (USPHS), alpha criteria rating system)	one year
Primary	marginal discoloration	Modified USPHS(United States Public Health Service (USPHS), alpha criteria rating system)	one year
Secondary	parent satisfaction	5-point Likert scale Likert scale(0-4)	immediate after intervention