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

NCT05973292 | Completed Phase 2

• 1 other identifier: M01160321
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Endodontically Treated Teeth; Anterior Teeth

Keywords

Digital Dentistry, E-max, MDP, Zirconia

Outcome Measures

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

  3-6-9-12 Months

Secondary Outcomes (1)

• Patient Satisfaction

  3-6-9-12 Months

Study Arms (4)

Group ZA

EXPERIMENTAL

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

Ggroup ZB

EXPERIMENTAL

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

Other: Non MDP containg resin cement

Group EA

EXPERIMENTAL

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

Group EB

EXPERIMENTAL

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

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

Also known as: Panavia SA

Group EA; Group ZA

Non MDP containg resin cement OTHER

Adhesive resin cement not containing an MDP agent

Also known as: Duo-link Universal

Ggroup ZB; Group EB

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Faculty of Dentistry,Mansoura University

Al Mansurah, Dakahlia Governorate, 33516, Egypt

Location

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Lamia Dawood, Professor

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The outcome assessors and participants were blinded throughout the whole procedure. The dentist practitioner was responsible for all clinical procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer- Prosthodontic Department- Faculty of Dentistry

Model Details: All patients received their treatment at the same time. Follow-up periods were parallel for all participants.

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 2, 2023
• Study Start: April 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: August 2, 2023

Record last verified: 2023-07

Locations

EG (1)