Comparative Study Between Zirconia Crowns and Endocrowns in Pulpotomized Primary Molars

Study Overview
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Brief Summary
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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..

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

Conditions
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Paediatric, Dentistry

Intervention / Treatment
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* Other: Endocrowns


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: . Free of systemic diseases. Age between 4 and 7 years. Takes no medication on regular basis. Has bilateral lower second primary molar with deep carious lesion, indicated for pulp therapy and crown restoration. (split mouth) Patient and parent compliance. Exclusion Criteria: 1. Non-restorable tooth. 2. Tooth near its exfoliation. 3. Tooth with extensive root resorption or periapical pathosis.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endocrown<br>Adhesive monoblock restoration for pulpotomized primary molars | Other: Endocrowns<br>* Adhesive monoblock restoration for pulpotomized primary molars<br>|
| Active Comparator: Zirconia crowns<br>Prefabricated primary full coverage crown | Other: Endocrowns<br>* Adhesive monoblock restoration for pulpotomized primary molars<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restoration integrity | Modified USPHS(United States Public Health Service (USPHS), alpha criteria rating system) | one year | 
| marginal adaptation | Modified USPHS(United States Public Health Service (USPHS), alpha criteria rating system) | one year | 
| marginal discoloration | Modified USPHS(United States Public Health Service (USPHS), alpha criteria rating system) | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| parent satisfaction | 5-point Likert scale Likert scale(0-4) | immediate after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aesthetic, Endo-crowns, primary, molars, pulpotomy, zirconium, crowns