Endocrowns in Anterior Teeth: Effect of Cementation Protocols and Restorative Materials on the Clinical Performance of the Restorations

July 26, 2023 updated by: Nehal Samra, Kafrelsheikh University
Rehabilitation of anterior endodontically treated teeth with significant coronal damage has been problematic. Adopting endocrown design to treat teeth with this condition is still under investigation. To address this issue, the USPHS criteria were adopted to assess the anterior endocrown restorations manufactured using various ceramic materials and cemented with different protocols.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

40 participants with anterior endodontically treated maxillary central incisors were enrolled to restore their teeth with esthetic restorations Patients were divided into two groups, zirconia and e-max groups. Each group was, further subdivided into two groups following the cementation protocol. Patients were evaluated immediately (baseline) and at. The clinical marginal accuracy measurements were carried out for all groups at baseline, 3, 6, 9, 12, and 18 months and evaluated by 3 investigators using Modified (USPHS). The patients' satisfaction and potential postoperative discomfort were also assessed and recorded during the same periods. All qualitative data were displayed as frequency (N) and Percentages (%). The chi-square test was utilized for qualitative data comparisons.

Results:

As to marginal integrity and patient satisfaction, no significant difference were revealed regarding all scores at different intervals as P>0.05.

Conclusions:

According to the findings of this study, ceramic endocrowns offer a promising restorative solution for the rehabilitation of anterior endodontically treated teeth. Additionally, regardless of the presence of the MDP monomer in its composition, using adhesive resin cement achieved highly successful results when used with MDP-based ceramic primers.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

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

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 33516
        • Faculty of Dentistry,Mansoura university

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • • Freshly extracted teeth.

    • Completely formed apices
    • Minimum root length of 14mm (± 0.5) measured from the cement-enamel junction to the root apex.
    • Straight roots.
    • Teeth with single root canal.
    • Sound teeth with no cracks or fractured parts in its crown or root.
    • Absence of any carious lesions.
    • No signs of internal or external root resorption.
    • Similar bucco-lingual (BL) and mesio-distal (MD) dimensions as determined with a digital caliper.

Exclusion Criteria:

  • • Previously endodontically treated teeth.

    • Markedly curved roots.
    • Root contains more than one canal.
    • Presence of canal calcifications or pulp stones.
    • Internal or external root resorption.
    • Presence of cracks, fractures or caries.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group ZA
Participants received Zirconia anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ MDP-containing resin cement.
Other: resin cement containing phosphate ester monomer 10-methacryloyloxydecyl dihydrogen phosphate
Adhesive resin cement containing an MDP agent that is added to bonding agents to enhance bonding to ceramics like Ziconia and E-max
Other Names:
  • Panavia SA
Experimental: Ggroup ZB
Participants received Zirconia anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ Non-MDP-containing resin cement.
Other: Non MDP containg resin cement
Adhesive resin cement not containing an MDP agent
Other Names:
  • Duo-link Universal
Experimental: Group EA
Participants received E-max anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ MDP-containing resin cement.
Other: resin cement containing phosphate ester monomer 10-methacryloyloxydecyl dihydrogen phosphate
Adhesive resin cement containing an MDP agent that is added to bonding agents to enhance bonding to ceramics like Ziconia and E-max
Other Names:
  • Panavia SA
Experimental: Group EB
Participants received E-max anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ Non-MDP-containing resin cement.
Other: Non MDP containg resin cement
Adhesive resin cement not containing an MDP agent
Other Names:
  • Duo-link Universal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal Integrity
Time Frame: 3-6-9-12 Months
Using a dental mirror and a dental explorer, endocrowns were checked from every aspect, buccal, mesial, distal and lingual to detect any marginal discontinuity, fractures, or gaps. Endocrown evaluation was carried out against The Modified USPHS criteria
3-6-9-12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction
Time Frame: 3-6-9-12 Months
Each patient was asked about his opinion regarding the restoration. Patients' answers and/or complaints were assessed and recorded against the USPHS criteria
3-6-9-12 Months

Collaborators and Investigators

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

Sponsor

Kafrelsheikh University

Investigators

  • Study Director: Lamia Dawood, Professor, Professor of Fixed Prosthodontics, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.

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 (Actual)

April 1, 2021

Primary Completion (Actual)

April 1, 2022

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

July 26, 2023

First Submitted That Met QC Criteria

July 26, 2023

First Posted (Actual)

August 2, 2023

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M01160321

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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