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Clinical Trials/NCT06212141
NCT06212141
Active, not recruiting
Not Applicable

Clinical Comparison of Convetional Bulk-Fill Composite Resins and Thermoviscous Bulk-Fill Composite Resins in Class II Restorations

Hacettepe University1 site in 1 country54 target enrollmentDecember 12, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Class II Dental Caries
Sponsor
Hacettepe University
Enrollment
54
Locations
1
Primary Endpoint
Postoperative sensitivity
Status
Active, not recruiting
Last Updated
5 months ago

Overview

Brief Summary

The goal of this clinical trial is to evaluate the clinical performance of Class II restorations of a thermoviscous nanohybrid materials , of a bulk-fill composite resin, and of conventional nanohyribrid bulk-fill composite resins .

Class II restorations will be performed in patients using three different restorative materials.And restorations will be evaluated using modified US Public Health Service criteria Resorations will be photograped and restorations will be evaluated for 6,12 months.

Detailed Description

The aim of this clinical study was to evaluate the clinical performance of Class II restorations of a thermoviscous nanohybrid materials , of a bulk-fill composite resin, and of conventional nanohyribrid bulk-fill composite resins. Methods and Materials: Class II restorations will be performed in patients using three different restorative materials: VisCalor Thermoviscous Bulk-Fill (VCB; a thermoviscous nanohybrid bulk-fill composite resin) , Admira Fusion x-tra ( AFT: a conventional nanohybrid bulk-fill composite resin) and 3M Filtek One Bulk-Fill Restprative (FOB: a conventional bulk-fill nanocomposite ) Futura Bond U adhesive will be used for both conventional bulk-fill composite resin restorations and thermoviscous bulk-fill composite resin restorations. Criteria for inclusion of patients in the study : Healthy individuals without any systemic disease, patients who is between 18 and 60 years old, patiens who brush their teeth 2 times a day,voluntary individuals who have agreed to participate in the study and signed the illuminated consent form, who have been given initial periodontal treatment. Criteria for not inclusion of volunteers in research:Women who are pregnant or breastfeeding ,patienrs with advanced periodontial disease,patiens using a moving segmental prosthesis,patiens who have maloclusions,patiens who have bruxism,patients with known allergies to resin-based restorative materials and binding agents The restorations will be evaluated using modified US Public Health Service criteria in terms of retention, color match, marginal discoloration, anatomic form, marginal adaptation, secondary caries, postoperative sensitivity, and surface texture. Resorations will be photograped and restorations will be evaluated for 6,12 months .

Registry
clinicaltrials.gov
Start Date
December 12, 2022
End Date
June 15, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Meriç Tuncer

principle investigator

Hacettepe University

Eligibility Criteria

Inclusion Criteria

  • Healthy individuals without any systemic disease
  • Patients who is between 18 and 60 years old,
  • Patiens who brush their teeth 2 times a day
  • Voluntary individuals who have agreed to participate in the study and signed the illuminated consent form, who have been given initial periodontal treatment.

Exclusion Criteria

  • Women who are pregnant or breastfeeding
  • Patients with advanced periodontial disease
  • Patiens using a moving segmental prosthesis
  • Patiens who have maloclusions,
  • Patiens who have bruxism,
  • Patients with known allergies to resin-based restorative materials and binding agents

Outcomes

Primary Outcomes

Postoperative sensitivity

Time Frame: From baseline to 18 month

Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by an independent clinician. Scores: Alfa: Not present. Bravo: sensitive but diminishing in intensity. . Charlie:constant sensitivity, not diminishing in intensity

Marginal Staining

Time Frame: From baseline to 18 month

Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal staining. Marginal staining was evaluated by an independent clinician. Visual inspection with a mirror was performed . Scores: Alfa: No discoloration. Bravo: Discoloration without. Charlie: Discoloration with penetration in pulpal direction

Retention

Time Frame: From baseline to 18 month

Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by an independent clinician. Scores: Alfa: No loss of restorative material. Charlie: Any loss of restorative material

Marginal Adaptation

Time Frame: From baseline to 18 month

Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal adaptation. Marginal adaptation was evaluated by an independent clinician. Visual inspection with a mirror was performed . Scores; Alfa: Closely adapted, no visible crevice. Bravo: Visible crevice, explorer will penetrate. Charlie: Crevice in which dentin is exposed

Seconder caries

Time Frame: From baseline to 18 month

Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by an independent clinician. Scores: Alfa: No caries present. Charlie: Caries present

Study Sites (1)

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