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

NCT ID: NCT05973292

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2022-04-01

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.

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.

Conditions

Endodontically Treated Teeth; Anterior Teeth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group ZA

Participants received Zirconia anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ MDP-containing resin cement.

Group Type: EXPERIMENTAL

resin cement containing phosphate ester monomer 10-methacryloyloxydecyl dihydrogen phosphate

Intervention Type: OTHER

Adhesive resin cement containing an MDP agent that is added to bonding agents to enhance bonding to ceramics like Ziconia and E-max

Ggroup ZB

Participants received Zirconia anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ Non-MDP-containing resin cement.

Group Type: EXPERIMENTAL

Non MDP containg resin cement

Intervention Type: OTHER

Adhesive resin cement not containing an MDP agent

Group EA

Participants received E-max anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ MDP-containing resin cement.

Group Type: EXPERIMENTAL

resin cement containing phosphate ester monomer 10-methacryloyloxydecyl dihydrogen phosphate

Intervention Type: OTHER

Adhesive resin cement containing an MDP agent that is added to bonding agents to enhance bonding to ceramics like Ziconia and E-max

Group EB

Participants received E-max anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ Non-MDP-containing resin cement.

Group Type: EXPERIMENTAL

Non MDP containg resin cement

Intervention Type: OTHER

Adhesive resin cement not containing an MDP agent

Interventions

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

Intervention Type: OTHER

Non MDP containg resin cement

Adhesive resin cement not containing an MDP agent

Intervention Type: OTHER

Other Intervention Names

Panavia SA; Duo-link Universal

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: lead

Responsible Party

Nehal Samra

Assistant Lecturer- Prosthodontic Department- Faculty of Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lamia Dawood, Professor

Role: STUDY_DIRECTOR

Professor of Fixed Prosthodontics, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.

Locations

Faculty of Dentistry,Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

M01160321

Identifier Type: -

Identifier Source: org_study_id