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

Primary Purpose

Endodontically Treated Teeth, Anterior Teeth

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
resin cement containing phosphate ester monomer 10-methacryloyloxydecyl dihydrogen phosphate
Non MDP containg resin cement
Sponsored by
Kafrelsheikh University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endodontically Treated Teeth focused on measuring Digital Dentistry, E-max, MDP, Zirconia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of Dentistry,Mansoura University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group ZA

Ggroup ZB

Group EA

Group EB

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 26, 2023
Last Updated
July 26, 2023
Sponsor
Kafrelsheikh University
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1. Study Identification

Unique Protocol Identification Number
NCT05973292
Brief Title
Endocrowns in Anterior Teeth: Effect of Cementation Protocols and Restorative Materials on the Clinical Performance of the Restorations
Official Title
Endocrowns in Anterior Teeth: Effect of Cementation Protocols and Restorative Materials on the Clinical Performance of the Restorations
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kafrelsheikh University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontically Treated Teeth, Anterior Teeth
Keywords
Digital Dentistry, E-max, MDP, Zirconia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
All patients received their treatment at the same time. Follow-up periods were parallel for all participants.
Masking
ParticipantOutcomes Assessor
Masking Description
The outcome assessors and participants were blinded throughout the whole procedure. The dentist practitioner was responsible for all clinical procedures.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group ZA
Arm Type
Experimental
Arm Description
Participants received Zirconia anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ MDP-containing resin cement.
Arm Title
Ggroup ZB
Arm Type
Experimental
Arm Description
Participants received Zirconia anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ Non-MDP-containing resin cement.
Arm Title
Group EA
Arm Type
Experimental
Arm Description
Participants received E-max anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ MDP-containing resin cement.
Arm Title
Group EB
Arm Type
Experimental
Arm Description
Participants received E-max anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ Non-MDP-containing resin cement.
Intervention Type
Other
Intervention Name(s)
resin cement containing phosphate ester monomer 10-methacryloyloxydecyl dihydrogen phosphate
Other Intervention Name(s)
Panavia SA
Intervention Description
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
Intervention Name(s)
Non MDP containg resin cement
Other Intervention Name(s)
Duo-link Universal
Intervention Description
Adhesive resin cement not containing an MDP agent
Primary Outcome Measure Information:
Title
Marginal Integrity
Description
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 Outcome Measure Information:
Title
Patient Satisfaction
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lamia Dawood, Professor
Organizational Affiliation
Professor of Fixed Prosthodontics, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry,Mansoura University
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
33516
Country
Egypt

12. IPD Sharing Statement

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

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