Composite Restorations Performed by Placing Polyethylene Fiber

NCT06346769 | Completed

• 1 other identifier: SelcukB
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

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).

Conditions

Endodontically Treated Teeth

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (3)

'O' shape polyethylene fiber

EXPERIMENTAL

Other: Polyethylene Fiber

mesiodistal I shape polyethylene fiber

EXPERIMENTAL

Other: Polyethylene Fiber

buccolingual I shape polyethylene fiber

EXPERIMENTAL

Other: Polyethylene Fiber

Interventions

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.

'O' shape polyethylene fiber; buccolingual I shape polyethylene fiber; mesiodistal I shape polyethylene fiber

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (2)

Selcuk University, Faculty of Dentistry, Restorative Dentistry Department

Konya, Turkey (Türkiye)

Location

Selcuk University, Faculty of Dentistry

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Officials

• MERVE GÜRSES

  Selcuk University, Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Proffesor

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 4, 2024
• Study Start: January 1, 2024
• Primary Completion: October 15, 2024
• Study Completion: April 15, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)