Evaluation of a New Design of Crowns in the Posterior Teeth

Study Overview
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Brief Summary
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Background: no randomized controlled trial has tried to compare treatment outcomes between the IPS.emmax endocrowns and the IPS.emmax conventional crowns . Objective: to investigate the clinical performance of the IPS.emmax endocrowns and the IPS.emmax conventional crowns Design and setting: Parallel-groups randomized controlled trial on patients with one or more intensive damaged molars requiring crowning and being treated at the University of Damascus, Dental School in Damascus, Syria .All molars will be examined at the baseline assessment using a modified US Public Health Service (USPHS) criteria. Participants: Incoming patients to the Fixed Prosthetic and Endodontic Departments will be examined to find any excessively damaged molars requiring crowning. Forty patients will be recruited according to specific inclusion criteria. Randomization will be performed using computer-generated tables; allocation will be concealed using sequentially numbered opaque and sealed envelopes.The included 40 patients will be analyzed (age range between 20-60 years). They will be randomly distributed into two groups with 20 patients in each group (1:1 allocation ratio). Intervention: Excessively damaged and endodontically treated molars will be restored with IPS.emmax endocrowns or IPS.emmax crowns supported with composite core. Main outcome measure: marginal adaptation and anatomic form will be investigated clinically and by apical radiographs at the baseline assessment using the modified (USPHS) at six assessment times during an 18-month observation period. Assessor blinding will be employed.

Official Title
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Evaluation of IPS E.Max-CAD Endocrown in Molars Compared to the Conventional Design

Conditions
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Broken Down Molars, IPS-emmax Crowns

Intervention / Treatment
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* Other: IPS.emmax endocrown


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 20 to 60 years old Good oral hygiene Gingival index (GI) equal 0 Plaque index (PI) equal 0 or 1 Primary acceptation and commitment to the trail Inclusion criteria of molars: Two remaining axial walls at least. 0.5 mm above the gingival line at least for damaged axial walls. Good endodontic treatment and apical seal First and second upper and lower molars only. Against teeth could be natural or crowned. Exclusion Criteria: Patients with an open bite or cross bite. Bruxism Periodontitis Gingival hyperplasia

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: IPS.emmax crown<br> | |
| Experimental: IPS.emmax endocrown<br>Patients with excessively undermined and endodontically treated molars will receive the IPS.emmax endocrown as the restoration of choice. | Other: IPS.emmax endocrown<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Marginal Adaptation | The presence of marginal adaptation means that the restoration margins cannot be distinguished, the probe cannot find a step between the margins and the surrounding tissue, and no discoloration visible. | at 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 15 months (T5), and 18 months (T6) following application | 
| Change in the Anatomic Form | The anatomic form is considered satisfactory when the crown has a correct contour with tight proximal contact, no worn facets on restorations and no worn facets on opposing teeth. | at 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 15 months (T5), and 18 months (T6) following application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Retention Status | Retention loss is considered when the crown becomes loose or mobile. | at 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 15 months (T5), and 18 months (T6) following application | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endocrown, marginal adaptation, anatomic form, retention loss, IPS.emmax crowns