Clinical Performance of Different Resin Cements

NCT ID: NCT04694690

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-20

Study Completion Date

2024-08-20

Brief Summary

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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.

Detailed Description

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Conditions

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Restoration of Posterior Teeth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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RelyX U200 Automix Self Adhesive Resin Cement

Self Adhesive Resin Cement

Group Type EXPERIMENTAL

Self adhesive resin cement

Intervention Type OTHER

Self adhesive resin cement

G-Cem LinkForce Resin Cement

Resin Cement system used after surface treatment

Group Type ACTIVE_COMPARATOR

Resin cement

Intervention Type OTHER

Resin Cement system used after surface treatment

Interventions

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Self adhesive resin cement

Self adhesive resin cement

Intervention Type OTHER

Resin cement

Resin Cement system used after surface treatment

Intervention Type OTHER

Other Intervention Names

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RelyX U 200 G-Cem LinkForce

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Simge Canatan

dentist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hacettepe University Faculty of Dentistry

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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CAD/CAM-hybrid

Identifier Type: -

Identifier Source: org_study_id

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