Clinical trial NCT04612543: Clinical Evaluation of Extensive Direct Composite Restorations With Polyethylene Fiber
Official title: Randomized, Controlled Clinical Evaluation of Extensive Direct Composite Restorations With Polyethylene Fiber in the First Permanent Molars of Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries Extending Into Dentin
Keywords: Composite resin
Clinical Evaluation
Polyethylene Fiber
First Permanent Molars
Extensive carious
Lead sponsor: Kafkas University
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 75
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: The aim of this clinical trial was to compare the clinical performances of composite resin restorations with/without the polyethylene fiber to the first permanent molar teeth with extensively carious pediatric patients. A total of 75 restorations with (FC; n=38)or without (C; n=37) fiber were placed in the first permanent molar teeth.

Restorations were evaluated at baseline-6-12-18 months according to the modified-USPHS criteria. Data were analyzed with Chi-Square and Cochran's Q (p\<0.05).

Detailed description: Fiber reinforced composite restorations developed in recent years have been presented to improve the negative properties of composite resin systems applied by the traditional method thanks to the fact that the fibers act as a crack stopper, reduce polymerization shrinkage by decreasing the the mass of composite resin material between the remaining dentin structure and the fiber. Many authors having conducted tremendous experience in this field of research have reported that the polyethylene fiber is an innovative approach because it not only increases the flexural strength but also improves fracture toughness. Its woven fiber orientation provides the stresses to be dispersed throughout the restoration, and therefore reinforces the restoration and the remaining tooth structure in multiple directions.

Eligibility criteria: Inclusion Criteria:

* no hypoplasia or any tissue abnormality in the teeth,
* deep dentin caries with three tubercle loss in the teeth, need of three surface restorations with coverage of at least two adjacent cusps.
* no evidence for pulpal complications
* in occlusion

Exclusion Criteria:

* partly erupted teeth;

  -.absence of adjacent and antagonist teeth
* poor periodontal status;
* adverse medical history;
* potential behavioral problems.

Primary outcomes:
measure: Marginal adaptation
timeFrame: From baseline to 18 months the change of restorations was evaluated
measure: marginal discoloration
timeFrame: From baseline to 18 months the change of restorations was evaluated
measure: retention rate
timeFrame: From baseline to 18 months the change of restorations was evaluated
measure: anatomic form
timeFrame: From baseline to 18 months the change of restorations was evaluated
measure: color change
timeFrame: From baseline to 18 months the change of restorations was evaluated
Secondary outcomes:
Other outcomes:
Locations:
city: Kars
country: Turkey
facility: Kafkas University School of Dentistry
Study officials:
affiliation: Kafkas University School of Dentistry
name: SEMANUR ÖZÜDOĞRU, Ass.. Prof
role: STUDY_DIRECTOR
References:
citation: Deliperi S, Alleman D, Rudo D. Stress-reduced Direct Composites for the Restoration of Structurally Compromised Teeth: Fiber Design According to the "Wallpapering" Technique. Oper Dent. 2017 May/Jun;42(3):233-243. doi: 10.2341/15-289-T.
citation: Candan U, Eronat N, Oncag O. Clinical performance of fiber-reinforced nanofilled resin composite in extensively carious posterior teeth of children: 30-month evaluation. J Clin Pediatr Dent. 2013 Fall;38(1):1-6. doi: 10.17796/jcpd.38.1.q352786473372282.
citation: Garoushi S, Lassila LV, Tezvergil A, Vallittu PK. Static and fatigue compression test for particulate filler composite resin with fiber-reinforced composite substructure. Dent Mater. 2007 Jan;23(1):17-23. doi: 10.1016/j.dental.2005.11.041. Epub 2006 Jan 18.