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

Sponsor
Kafrelsheikh University (Other)
Overall Status
Completed
CT.gov ID
NCT05973292
Collaborator
(none)
40
Enrollment
1
Location
4
Arms
12
Actual Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: resin cement containing phosphate ester monomer 10-methacryloyloxydecyl dihydrogen phosphate
  • Other: Non MDP containg resin cement
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
All patients received their treatment at the same time. Follow-up periods were parallel for all participants.All patients received their treatment at the same time. Follow-up periods were parallel for all participants.
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
The outcome assessors and participants were blinded throughout the whole procedure. The dentist practitioner was responsible for all clinical procedures.
Primary Purpose:
Treatment
Official Title:
Endocrowns in Anterior Teeth: Effect of Cementation Protocols and Restorative Materials on the Clinical Performance of the Restorations
Actual Study Start Date :
Apr 1, 2021
Actual Primary Completion Date :
Apr 1, 2022
Actual Study Completion Date :
Apr 1, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Marginal Integrity [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

    Secondary Outcome Measures

    1. Patient Satisfaction [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Dentistry,Mansoura University Mansoura Dakahlia Egypt 33516

    Sponsors and Collaborators

    • Kafrelsheikh University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nehal Samra, Assistant Lecturer- Prosthodontic Department- Faculty of Dentistry, Kafrelsheikh University
    ClinicalTrials.gov Identifier:
    NCT05973292
    Other Study ID Numbers:
    • M01160321
    First Posted:
    Aug 2, 2023
    Last Update Posted:
    Aug 2, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nehal Samra, Assistant Lecturer- Prosthodontic Department- Faculty of Dentistry, Kafrelsheikh University
    Digital Dentistry, E-max, MDP, Zirconia
    Additional relevant MeSH terms:
    Tooth, Nonvital

    Study Results

    No Results Posted as of Aug 2, 2023