Composite Restorations Performed by Placing Polyethylene Fiber

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

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).

Study Overview

• Status: Completed
• Conditions: Endodontically Treated Teeth
• Intervention / Treatment: Other: Polyethylene Fiber

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey
    • Selcuk University, Faculty of Dentistry, Restorative Dentistry Department
  • Konya, Turkey
    • Selcuk University, Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

A patient presenting with;

1. over 18 years of age
2. a normal periodontal status and good general health
3. endodontically treated premolar and molar teeth
4. teeth in contact with the opposing tooth and subjected to normal occlusal forces
5. attend follow-up appointments

Exclusion Criteria:

1. poor oral hygiene status
2. those with severe or chronic periodontitis
3. absence of adjacent and antagonist teeth
4. potential behavioral problems (e.g. bruxism)
5. allergy to any product used in the study
6. systemically unhealthy
7. pregnant and lactating women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 'O' shape polyethylene fiber	Other: Polyethylene Fiber; 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.
Experimental: mesiodistal I shape polyethylene fiber	Other: Polyethylene Fiber; 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.
Experimental: buccolingual I shape polyethylene fiber	Other: Polyethylene Fiber; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention	No loss of restorative material	Seventh day, sixth month, twelfth month
Color match	The restoration matches the adjacent tooth structure in color and translucency	Seventh day, sixth month, twelfth month
Marginal Discoloration	There is no discoloration anywhere on the margin between the restoration and the tooth structure	Seventh day, sixth month, twelfth month
Marginal adaptation	There is no visible evidence of a crevice along the margin into which the explorer will penetrate	Seventh day, sixth month, twelfth month
Secondary caries	No evidence of secondary caries	Seventh day, sixth month, twelfth month
Surface texture	The surface of the restoration does not have any defects	Seventh day, sixth month, twelfth month
Anatomical form	The restoration is continuous with the existing anatomic form	Seventh day, sixth month, twelfth month

Collaborators and Investigators

• Sponsor: Selcuk University
• Investigators: Principal Investigator: MERVE GÜRSES, Selcuk University, Faculty of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): October 15, 2024
• Study Completion (Actual): April 15, 2025

Study Registration Dates

• First Submitted: March 29, 2024
• First Submitted That Met QC Criteria: March 29, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 25, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Dental Pulp Diseases; Tooth Diseases; Tooth, Nonvital
• Other Study ID Numbers: SelcukB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No