Evaluation of a New Design of Crowns in the Posterior Teeth

October 2, 2015 updated by: Damascus University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Syrian Arab Republic
      • Damascus, Syrian Arab Republic, DM20AM18
        • Department of Fixed Prosthodontics, University of Damsacus
      • Damascus, Syrian Arab Republic, DM20AM18
        • University of Damascus Dental School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Marginal Adaptation
Time Frame: at 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 15 months (T5), and 18 months (T6) following application
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
Time Frame: at 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 15 months (T5), and 18 months (T6) following application
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
Time Frame: at 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 15 months (T5), and 18 months (T6) following application
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Investigators

  • Principal Investigator: Rana Dallool, DDS, University of Damascus Dental School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

April 7, 2014

First Submitted That Met QC Criteria

April 8, 2014

First Posted (Estimate)

April 10, 2014

Study Record Updates

Last Update Posted (Estimate)

October 5, 2015

Last Update Submitted That Met QC Criteria

October 2, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UDDS-FixPro-01-2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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