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Completed

NCT Number: NCT05973292

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

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.

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Key information

Conditions

Endodontically Treated Teeth Anterior Teeth Dental Pulp Diseases Stomatognathic Diseases Tooth Diseases Tooth, Nonvital

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Dentistry,Mansoura University

Al Mansurah, Dakahlia Governorate, 33516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

resin cement containing phosphate ester monomer 10-methacryloyloxydecyl dihydrogen phosphate

Other

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

Non MDP containg resin cement

Other

Adhesive resin cement not containing an MDP agent

Other names: Duo-link Universal

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 2, 2023
Registry last updated
Aug 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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