Comparative Study Between Zirconia Crowns and Endocrowns in Pulpotomized Primary Molars

NCT ID: NCT04073901

Last Updated: 2020-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-02
• Study Completion Date: 2019-07-30

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..

Conditions

Paediatric; Dentistry

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endocrown

Adhesive monoblock restoration for pulpotomized primary molars

Group Type: EXPERIMENTAL

Endocrowns

Intervention Type: OTHER

Adhesive monoblock restoration for pulpotomized primary molars

Zirconia crowns

Prefabricated primary full coverage crown

Group Type: ACTIVE_COMPARATOR

Endocrowns

Intervention Type: OTHER

Adhesive monoblock restoration for pulpotomized primary molars

Interventions

Endocrowns

Adhesive monoblock restoration for pulpotomized primary molars

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nahda University

OTHER

Sponsor Role: lead

Responsible Party

Yassmine mohamed farouk el makawi

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Yassmine Mohamed Farouk El Makawi

Cairo, , Egypt

Countries

Egypt

Other Identifiers

186

Identifier Type: -

Identifier Source: org_study_id