Digital, Conventional, And Biomimetic Approaches for Restoring Endodontically Treated Teeth

NCT06717230 | Recruiting

• 1 other identifier: 11-2024
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

Endocrowns are preferred over the post-retained crown, especially at a young age for many reasons; they allow better gingival health and care due to placement of the supragingival margin, have greater fracture resistance limiting the risk for root fracture, thus improving the long-term prognosis of ETMs and has a superior ability to restore ETMs with short crowns, calcified root canals, and thin roots. Furthermore, using CAD/CAM technology facilitates Endocrowns preparation making it simpler with less invasive techniques that can be prepared, fabricated, and cemented in a single visit. The high demand for permanent, esthetic, and conservative restorations has directed clinicians to restore permanent ETMs at a young age with Endo crowns as final coronal restorations. In addition, Biomimetic dentistry leverages modern materials to replicate the biological and mechanical functions of natural teeth, presenting a distinct approach that minimizes the need for extensive tooth reduction and post-placement, particularly advantageous for endodontically treated teeth. Utilizing fiber-reinforced composites, this technique aims to strengthen the dentin-resin bond and evenly distribute occlusal forces across the restoration. By closely adhering to the intact tooth's natural contours and functionality, biomimetic restorations not only preserve more of the natural tooth structure but also reduce stress and strain within the restored tooth. This approach enhances longevity and minimizes the risk of bond failure, with any necessary repairs being straightforward and contributing to the restoration's sustainability. This study explores the application of fiber-reinforced composites within a biomimetic framework for restoring endodontically treated teeth, aiming to achieve durable and biologically compatible outcomes.

Conditions

Endodontically Treated Teeth

Outcome Measures

Primary Outcomes (1)

• Clinical success and survival of restoration

  * Clinical success will be evaluated using (a modified version of the United States Public Health Service (USPHS) criteria which involves the assessment of margins, anatomic form, surface texture, and shade match. (Rate: Alfa, Bravo, Charlie) * Each parameter will be assessed using visual and tactile observations (probe, mirror, and dental floss). * Treatment will be considered a failure if the restoration had to be remade for any reason including debonding, fracture, or poor appearance, during the 12-month observation period.

  12 months

Secondary Outcomes (2)

• The radiographic assessment

  12 months

• Patient-centred outcomes to the restoration

  12 months

Study Arms (2)

EverX Posterior with Vita Endo-Crowns, EverX Posterior with Bulk-Fill Resin Restorations

EXPERIMENTAL

Biomimetic dentistry leverages modern materials to replicate the biological and mechanical functions of natural teeth, presenting a distinct approach that minimizes the need for extensive tooth reduction and post-placement, particularly advantageous for endodontically treated teeth. Utilizing fiber-reinforced composites, this technique aims to strengthen the dentin-resin bond and evenly distribute occlusal forces across the restoration. By closely adhering to the intact tooth's natural contours and functionality, biomimetic restorations not only preserve more of the natural tooth structure but also reduce stress and strain within the restored tooth. This approach enhances longevity and minimizes the risk of bond failure, with any necessary repairs being straightforward and contributing to the restoration's sustainability.

Other: EverX Posterior

Lithium Disilicate Endo-Crowns

ACTIVE COMPARATOR

conventional restoration for endodontically treated teeth

Other: EverX Posterior

Interventions

EverX Posterior OTHER

Restoration

EverX Posterior with Vita Endo-Crowns, EverX Posterior with Bulk-Fill Resin Restorations; Lithium Disilicate Endo-Crowns

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Endodontically-treated molar tooth with significant loss of tooth structure (both marginal ridges lost) requiring cuspal coverage.
• Patients aged ≥15 years.
• Controlled dental disease - no active caries or periodontal diseases
• Patients will be available to be clinically reviewed up to 1 year

You may not qualify if:

• Patients with poor oral hygiene.
• Teeth with extensive cracks or fractures.
• Deep subgingival margins (\>0.5mm subgingival).
• Non-restorable teeth.
• Non-functional teeth (no opposing dentition).
• Pocket probing depth \> 3mm.
• Mobility.
• Patients with bruxism.

Sponsors & Collaborators

• October University for Modern Sciences and Arts: lead

Study Sites (2)

MSA University

El-Sheikh Zayed City, Giza Governorate, 16672, Egypt

RECRUITING

MSA University

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Tooth, Nonvital

Interventions

EverX Posterior

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Marwa Salmoon, Ph.D

CONTACT

01016555055; maasalmoon@msa.edu.eg

Marwa A Salmoon, Ph.D

CONTACT

01016555055; maasalmoon@msa.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The child participants and the legal guardian of each participating child and the statistician were blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 4, 2024
• Study Start: September 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 16, 2024

Record last verified: 2024-11

Locations

EG (2)