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CompletedNCT05973292Updated Aug 2, 2023

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

A Phase 2 interventional study of resin cement containing phosphate ester monomer 10-methacryloyloxydecyl dihydrogen phosphate and Non MDP containg resin cement in Endodontically Treated Teeth and Anterior Teeth, sponsored by Kafrelsheikh University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-02.

Sponsored by Kafrelsheikh University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 3 months after the study started (first participant enrolled Apr 2021, registered Jul 2023).
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Endodontically Treated Teeth
  • Anterior Teeth

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Keywords

  • Digital Dentistry, E-max, MDP, Zirconia
03

In context

Tooth, Nonvital

113 studies on the registry are indexed under Tooth, Nonvital; 19 are open to participants now.

This study's enrollment of 40 is below the median of 50 across 103 interventional studies indexed under Tooth, Nonvital.

Browse Tooth, Nonvital studies →

Lead sponsor

Kafrelsheikh University is the lead sponsor of 285 studies on the registry; 110 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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

Interventions

  • Otherresin 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

    Also known as: Panavia SA

  • OtherNon MDP containg resin cement

    Adhesive resin cement not containing an MDP agent

    Also known as: Duo-link Universal

06

What researchers measure

Primary outcomes

  1. Marginal Integrity

    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

    Time frame: 3-6-9-12 Months

Secondary outcomes

  1. Patient Satisfaction

    Each patient was asked about his opinion regarding the restoration. Patients' answers and/or complaints were assessed and recorded against the USPHS criteria

    Time frame: 3-6-9-12 Months

07

Study locations

1 site
  • Faculty of Dentistry,Mansoura University
    Mansoura, Dakahlia 33516, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05973292
Lead sponsor
Kafrelsheikh University
Responsible party
Nehal Samra (Assistant Lecturer- Prosthodontic Department- Faculty of Dentistry, Kafrelsheikh University) — Principal investigator
First posted
Aug 2, 2023
Start date
Apr 1, 2021
Primary completion
Apr 1, 2022
Completion
Apr 1, 2022
Last update
Aug 2, 2023

Study contacts

Lamia Dawood, Professor
study director · Professor of Fixed Prosthodontics, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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