Composite Restorations Performed by Placing Polyethylene Fiber

Not Applicable

Completed

• Conditions: Endodontically Treated Teeth
• Interventions: Other: Polyethylene Fiber

• Registration Number: NCT06346769
• Lead Sponsor: Selcuk University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2024-03-29
• Study First Submitted QC: 2024-03-29
• Study First Posted: 2024-04-04
• Primary Completion: 2024-10-15
• Status Verified: 2025-04
• Study Completion: 2025-04-15
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
'O' shape polyethylene fiber	Polyethylene Fiber	-
buccolingual I shape polyethylene fiber	Polyethylene Fiber	-
mesiodistal I shape polyethylene fiber	Polyethylene Fiber	-

Primary Outcome Measures

Name	Time	Method
Retention	Seventh day, sixth month, twelfth month	No loss of restorative material
Secondary caries	Seventh day, sixth month, twelfth month	No evidence of secondary caries
Marginal adaptation	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	Seventh day, sixth month, twelfth month	There is no discoloration anywhere on the margin between the restoration and the tooth structure
Surface texture	Seventh day, sixth month, twelfth month	The surface of the restoration does not have any defects
Color match	Seventh day, sixth month, twelfth month	The restoration matches the adjacent tooth structure in color and translucency
Anatomical form	Seventh day, sixth month, twelfth month	The restoration is continuous with the existing anatomic form

Trial Locations

Locations (2)

Selcuk University, Faculty of Dentistry; 🇹🇷 Konya, Turkey

Selcuk University, Faculty of Dentistry, Restorative Dentistry Department; 🇹🇷 Konya, Turkey