Composite Restorations Performed by Placing Polyethylene Fiber

Endodontically Treated Teeth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06346769
• Other study ID #: SelcukB
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: April 15, 2025

Study information

• Verified date: March 2024
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 68
• Est. completion date: April 15, 2025
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Endodontically Treated Teeth
• Tooth, Nonvital

Intervention

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.

Locations

Country	Name	City	State
Turkey	Selcuk University, Faculty of Dentistry	Konya
Turkey	Selcuk University, Faculty of Dentistry, Restorative Dentistry Department	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

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