Clinical Performance of Different Resin Cements

NCT04694690 | Active Not Recruiting DMC

• 1 other identifier: CAD/CAM-hybrid
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The clinical performance of different resin cements in adhesion of hybrid ceramic inlay and onlay restorations produced with CAD/CAM will be evaluated and compared. After obtaining a signed informed consent form from all the patients, all restorations will be placed by a single clinician. All hyrid ceramic restorations (Cerasmart, GC, Tokyo, Japan) will be produced using the same CAD/CAM CEREC Omnicam (Sirona Dental, Bensheim, Germany) system. 70 restorations will be divided into 2 groups: a self adhesive resin cement (RelyX U200 Automix, 3M ESPE, Seefeld, Germany), and an adhesive cement (G-Cem LinkForce, GC, Tokyo, Japan) which is applied after surface treatment (etch\&rinse). All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after baseline, 6,12, 18, 24, 36 and 48 months. Descriptive statistics will be performed using Friedman test and Chi-square test.

Conditions

Restoration of Posterior Teeth

Keywords

CAD/CAM; Inlay; Onlay; Hybrid ceramic; Adhesive resin cement

Outcome Measures

Primary Outcomes (1)

• Clinical performance

  18 months- Modified United States Public Health Service

  18 months

Study Arms (2)

RelyX U200 Automix Self Adhesive Resin Cement

EXPERIMENTAL

Self Adhesive Resin Cement

Other: Self adhesive resin cement

G-Cem LinkForce Resin Cement

ACTIVE COMPARATOR

Resin Cement system used after surface treatment

Other: Resin cement

Interventions

Self adhesive resin cement OTHER

Self adhesive resin cement

Also known as: RelyX U 200

RelyX U200 Automix Self Adhesive Resin Cement

Resin cement OTHER

Resin Cement system used after surface treatment

Also known as: G-Cem LinkForce

G-Cem LinkForce Resin Cement

Eligibility Criteria

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

You may qualify if:

• Healthy individuals with or without systemic disease
• Patiens older than 18 years old
• Good oral health
• Patients who at least have1 large and deep carious lesion or broken restoration in a vital tooth
• Patients who agreed to participate in the study after being informed about this study

You may not qualify if:

• Patient with periodontal disease
• Patients with partial dentures
• Patients with bruxism
• Patients with malooclusion
• Non vital or endodontically treated teeth
• Preparetions under the cemento-enamel junction

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Faculty of Dentistry

Ankara, 06060, Turkey (Türkiye)

Location

MeSH Terms

Interventions

RelyX U200; Resin Cements

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dentist

Study Record Dates

• First Submitted: January 2, 2021
• First Posted: January 5, 2021
• Study Start: November 20, 2018
• Primary Completion: February 20, 2019
• Study Completion: August 20, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

TU (1)