Comparative Study Between Zirconia Crowns and Endocrowns in Pulpotomized Primary Molars

Not Applicable

Completed

• Conditions: Paediatric; Dentistry
• Interventions: Other: Endocrowns

• Registration Number: NCT04073901
• Lead Sponsor: Nahda 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 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..

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-02
• Primary Completion: 2018-06-03
• Study Completion: 2019-07-30
• Study First Submitted: 2019-08-22
• Study First Submitted QC: 2019-08-28
• Study First Posted: 2019-08-29
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-20
• Last Update Posted: 2020-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Endocrown	Endocrowns	Adhesive monoblock restoration for pulpotomized primary molars
Zirconia crowns	Endocrowns	Prefabricated primary full coverage crown

Primary Outcome Measures

Name	Time	Method
marginal adaptation	one year	Modified USPHS(United States Public Health Service (USPHS), alpha criteria rating system)
marginal discoloration	one year	Modified USPHS(United States Public Health Service (USPHS), alpha criteria rating system)
Restoration integrity	one year	Modified USPHS(United States Public Health Service (USPHS), alpha criteria rating system)

Secondary Outcome Measures

Name	Time	Method
parent satisfaction	immediate after intervention	5-point Likert scale Likert scale(0-4)

Trial Locations

Locations (1)

Yassmine Mohamed Farouk El Makawi; 🇪🇬 Cairo, Egypt