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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04073901
Other study ID # 186
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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