Clinical trial NCT06346769: Composite Restorations Performed by Placing Polyethylene Fiber
Official title: Clinical Evaluation of Composite Restorations Performed by Placing Polyethylene Fiber in Endodontically Treated Posterior Teeth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endodontically Treated Teeth
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Retention
timeFrame: Seventh day, sixth month, twelfth month
measure: Color match
timeFrame: Seventh day, sixth month, twelfth month
measure: Marginal Discoloration
timeFrame: Seventh day, sixth month, twelfth month
measure: Marginal adaptation
timeFrame: Seventh day, sixth month, twelfth month
measure: Secondary caries
timeFrame: Seventh day, sixth month, twelfth month
measure: Surface texture
timeFrame: Seventh day, sixth month, twelfth month
measure: Anatomical form
timeFrame: Seventh day, sixth month, twelfth month
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University, Faculty of Dentistry, Restorative Dentistry Department
city: Konya
country: Turkey
facility: Selcuk University, Faculty of Dentistry
Study officials:
affiliation: Selcuk University, Faculty of Dentistry
name: MERVE GÜRSES
role: PRINCIPAL_INVESTIGATOR
References: