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Completed

NCT Number: NCT06346769

Composite Restorations Performed by Placing Polyethylene Fiber

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).

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Selcuk University, Faculty of Dentistry, Konya, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polyethylene Fiber

Other

In the restoration of the endodontically treated posterior teeth, polyethylene fiber was placed in different directions ('O' shape, mesiodistal I shape, buccolingual I shape) according to the amount of remaining tooth tissue and cavity preparation.

Primary outcomes

  1. Retention

    Time frame: Seventh day, sixth month, twelfth month

    No loss of restorative material

  2. Color match

    Time frame: Seventh day, sixth month, twelfth month

    The restoration matches the adjacent tooth structure in color and translucency

  3. 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

  4. 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

  5. Secondary caries

    Time frame: Seventh day, sixth month, twelfth month

    No evidence of secondary caries

  6. Surface texture

    Time frame: Seventh day, sixth month, twelfth month

    The surface of the restoration does not have any defects

  7. Anatomical form

    Time frame: Seventh day, sixth month, twelfth month

    The restoration is continuous with the existing anatomic form

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 4, 2024
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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