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

Endodontically Treated Teeth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05973292
• Other study ID #: M01160321
• Status: Completed
• Phase: Phase 2
• Start date: April 1, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: July 2023
• Source: Kafrelsheikh University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Teeth
• Endodontically Treated Teeth
• Tooth, Nonvital

Intervention

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
• Non MDP containg resin cement
Adhesive resin cement not containing an MDP agent

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry,Mansoura University	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3-6-9-12 Months
Secondary	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	3-6-9-12 Months