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Clinical Trials/NCT06346756
NCT06346756
Completed
Not Applicable

Clinical Evaluation of Class II Restorations Performed With High-fill Injectable Composite and Condensable Universal Composites

Selcuk University1 site in 1 country71 target enrollmentJanuary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Caries
Sponsor
Selcuk University
Enrollment
71
Locations
1
Primary Endpoint
Retention
Status
Completed
Last Updated
last year

Overview

Brief Summary

This study aims to evaluate the one-year clinical performance of Class II restorations made with high-filling injectable and condensable universal composite resins.

The study included 71 patients and 140 restorations. It used G-aenial Universal Injectable (GCI), G-aenial A'CHORD (GCA), Tetric Prime (TP), Filtek Ultimate (FU) composites, and the Clearfil SE Bond adhesive system. Restorations were evaluated and scored according to modified USPHS criteria at seven days, six months, and one year. Chi-square and Cochran Q tests were used for statistical analysis (p<0.05).

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
July 15, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Merve Gurses

Assistant Professor

Selcuk University

Eligibility Criteria

Inclusion Criteria

  • A patient presenting with;
  • over 18 years of age
  • a normal periodontal status and good general health
  • proximal caries that are similar in size to premolar and molar teeth
  • vital teeth
  • teeth in contact with the opposing tooth and subjected to normal occlusal forces
  • attend follow-up appointments

Exclusion Criteria

  • poor oral hygiene status
  • those with severe or chronic periodontitis
  • absence of adjacent and antagonist teeth
  • potential behavioral problems (e.g. bruxism)
  • allergy to any product used in the study
  • exposure of the pulp during cavity preparation
  • systemically unhealthy
  • pregnant and lactating women

Outcomes

Primary Outcomes

Retention

Time Frame: seventh day, sixth month, twelfth month

No loss of restorative material

Secondary Outcomes

  • marginal adaptation(seventh day, sixth month, twelfth month)
  • anatomical form(seventh day, sixth month, twelfth month)
  • postoperative sensitivity(seventh day, sixth month, twelfth month)
  • surface texture(seventh day, sixth month, twelfth month)
  • color match(seventh day, sixth month, twelfth month)
  • marginal discoloration(seventh day, sixth month, twelfth month)
  • secondary caries(seventh day, sixth month, twelfth month)

Study Sites (1)

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