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Clinical Trials/NCT06346769
NCT06346769
Completed
Not Applicable

Clinical Evaluation of Composite Restorations Performed by Placing Polyethylene Fiber in Endodontically Treated Posterior Teeth

Selcuk University2 sites in 1 country68 target enrollmentJanuary 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endodontically Treated Teeth
Sponsor
Selcuk University
Enrollment
68
Locations
2
Primary Endpoint
Retention
Status
Completed
Last Updated
last year

Overview

Brief Summary

This study aimed to evaluate the 12-month clinical performance of direct composite restorations by placing polyethylene fibers in different directions in endodontically treated posterior teeth. In this clinical study, Clearfil SE Bond (Kuraray/Japan) adhesive system, G-aenial Universal Injectable (GC/Tokyo, Japan), G-aenial A'chord (GC/Tokyo, Japan) composites, and polyethylene fiber (Ribbond, USA) were used. In the restoration of the teeth included in the study, polyethylene fiber was placed in different directions according to the amount of remaining tooth tissue and cavity preparation. The restorations were divided into three groups according to the direction of fiber placement ('O' shape, mesiodistal I shape, buccolingual I shape) (n=12). Restorations were evaluated according to modified USPHS criteria in 1st week and 6th months from the placement date. The Chi-square test was used for statistical analysis of the difference between the groups, and the Cochran Q test was used for the significance of the difference between time-dependent changes within each group (p<0.05).

Registry
clinicaltrials.gov
Start Date
January 1, 2024
End Date
April 15, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Merve Gurses

Assistant Proffesor

Selcuk University

Eligibility Criteria

Inclusion Criteria

  • A patient presenting with;
  • over 18 years of age
  • a normal periodontal status and good general health
  • endodontically treated premolar and molar 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
  • systemically unhealthy
  • pregnant and lactating women

Outcomes

Primary Outcomes

Retention

Time Frame: Seventh day, sixth month, twelfth month

No loss of restorative material

Secondary caries

Time Frame: Seventh day, sixth month, twelfth month

No evidence of secondary caries

Marginal adaptation

Time Frame: Seventh day, sixth month, twelfth month

There is no visible evidence of a crevice along the margin into which the explorer will penetrate

Marginal Discoloration

Time Frame: Seventh day, sixth month, twelfth month

There is no discoloration anywhere on the margin between the restoration and the tooth structure

Surface texture

Time Frame: Seventh day, sixth month, twelfth month

The surface of the restoration does not have any defects

Color match

Time Frame: Seventh day, sixth month, twelfth month

The restoration matches the adjacent tooth structure in color and translucency

Anatomical form

Time Frame: Seventh day, sixth month, twelfth month

The restoration is continuous with the existing anatomic form

Study Sites (2)

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