Comparison of the Clinical Performance of High Strength Hybrid Ceramic Indirect Restorations Cemented on Endodontically Treated Teeth Using Bioactive Versus Conventional Self Adhesive Resin Cements.

NCT06787469 | Not Yet Recruiting

• 1 other identifier: ANCU-8-1-2025
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cementation of indirect restoration is a determinant of the success or failure of the fabricated restoration and consequentially the entire tooth. While there are numerous commercially available resin cements in the dental market, not all have been sufficiently assessed with significant follow up periods to clinically determine their success or failure. As such, this research will be conducted to elucidate if there is a viability to the cementation of indirect hybrid ceramic blocks over endodontically treated teeth using bioactive self-adhesive resin cement and determining whether it provides a clinical advantage and improved restoration serviceability in the oral cavity.

Conditions

Endodontically Treated Molar

Keywords

Resin Cement; SHOFU; Bioactive Resin Cement; SPRG; S-PRG; Endodontically treated teeth; BeautiLink SA

Outcome Measures

Primary Outcomes (1)

• Modified USPHS Criteria

  2 years

Study Arms (2)

Indirect Restorations cemented using Coltene Solocem Resin Cement

ACTIVE COMPARATOR

Other: Resin Cement

Indirect Restorations cemented using SHOFU BeautiLink Resin Cement

ACTIVE COMPARATOR

Other: Resin Cement

Interventions

Resin Cement OTHER

Bioactive self adhesive resin cement (SHOFU BeautiLink) used to cement indirect restorations to endodontically treated molars.

Indirect Restorations cemented using SHOFU BeautiLink Resin Cement

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient Related Criteria:
• Adult patients (age: 21-50 years) of both genders.
• Able to tolerate necessary restorative procedures.
• Willing to sign the informed consent.
• Accepts the follow-up period.
• Tooth Related Criteria:
• Endodontically treated first and second permanent molars.
• Access cavities with one missing proximal wall i.e. Occluso-mesial/distal cavities
• Patients with proper oral hygiene

You may not qualify if:

• Endodontically treated anterior, premolar and third molar teeth
• Badly broken-down teeth
• Hopelessly carious/destructed teeth necessitating extraction
• Mobile teeth, indicating periodontal disease or trauma.
• External or internal resorption.
• Cervical carious lesions
• Medically compromised patients
• Patients with known allergies to Latex and/or resinous material

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Tooth, Nonvital

Interventions

Resin Cements

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Resins, Synthetic; Plastics; Polymers; Macromolecular Substances; Dental Cements; Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Ahmed N Shalaby, Masters Restorative Dentistry

CONTACT

+201014850792; ahmad.shalaby@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer - Conservative Dentistry Department - MIU

Model Details: This study will be conducted on the form of a randomized controlled, unicenter, clustered two-arm superiority trial with a 1:1 allocation.

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 22, 2025
• Study Start: June 23, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR