Clinical Evaluation of Extensive Direct Composite Restorations With Polyethylene Fiber

Dental Caries Extending Into Dentin Clinical Trial

Official title:

Randomized, Controlled Clinical Evaluation of Extensive Direct Composite Restorations With Polyethylene Fiber in the First Permanent Molars of Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04612543
• Other study ID #: KafkasU
• Status: Completed
• Phase: N/A
• Start date: February 10, 2019
• Est. completion date: August 31, 2020

Study information

• Verified date: October 2020
• Source: Kafkas University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 31, 2020
• Est. primary completion date: August 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries Extending Into Dentin

Intervention

Device:
• Genial Posterior Composite with Polyethylene Fiber
Placing restorations,Genial Posterior Composite with Polyethylene Fiber, after bonding procedures, remaining tooth composite resin walls were created and cured for 20 s. Prepared ribbond fiber pieces, 2-mm-wide approximately 12mm-long, (Ribbond Thinner, Higher, Modulus, Ribbond Inc,Seattle) were wetted with an unfilled resin for 2 minutes at a non-light environment. The inner surfaces of the prepared class I cavity were lined with flowable resin. After removing the excess resin, pre-wetted polyethylene fiber was condensed circumferentially and embedded with a hand instrument into the bed of unpolymerized flowable composite and then polymerized for 20 seconds with Light Emitting Diodes. After curing for 20 s, composite resin was applied to the rest of the cavity incrementally, each increment was cured for 20 seconds. Finally, the restoration was shaped with finishing diamonds and silicon instruments.
• Genial Posterior Composite
Placing Genial Posterior Composite, the enamel and dentin were conditioned with bonding procedure using an applicator, left undisturbed for five to 10 seconds, and then dried thoroughly for five seconds with oil-free air under air pressure, Genial Direct Posterior resin was applied with the incremental technique (2 mm thick layers) and light-cured for 20 seconds. Finally, the restoration was shaped with finishing diamonds and silicon instruments

Locations

Country	Name	City	State
Turkey	Kafkas University School of Dentistry	Kars

Sponsors (1)

Lead Sponsor	Collaborator
Kafkas University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Candan U, Eronat N, Onçag 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. — View 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. — View 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. Epub 2006 Jan 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Marginal adaptation	Observers evaluated the restorations was performed using the modified United State Public Health Service criteria Observers evaluated the restorations was performed using the modified United State Public Health Service criteria which was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed. A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1: Harmonious outline Alpha 2: Marginal gap with discoloration (removable)	From baseline to 18 months the change of restorations was evaluated
Primary	marginal discoloration	Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth. Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction	From baseline to 18 months the change of restorations was evaluated
Primary	retention rate	Alpha 1:Clinically excellent Alpha 2: Clinically good with slight deviations from ideal performance, correction possible without damage of tooth or restoration Bravo: Clinically sufficient with few defects, corrections or repair of the restoration possible Charlie: Restoration is partially missed Delta: Restoration is totally missed	From baseline to 18 months the change of restorations was evaluated
Primary	anatomic form	Alpha 1: Continuous with existing anatomical form Alpha 2: Slightly discontinuous due to some chipping on the proximal ridge Bravo: Discontinuous with existing anatomical form due to material loss but proximal contact still present Charlie: Proximal contact is lost with ridge fracture.	From baseline to 18 months the change of restorations was evaluated
Primary	color change	Alpha: The restoration matches the adjacent tooth structure in color and translucency.; Bravo: Light mismatch in color, shade or translucency between the restoration and the adjacent tooth. Charlie: The mismatch in color and translucency is outside the acceptable range of tooth color and translucency; Alpha: The restoration matches the adjacent tooth structure in color and translucency.; Bravo: Light mismatch in color, shade or translucency between the restoration and the adjacent tooth. Charlie: The mismatch in color and translucency is outside the acceptable range of tooth color and translucency	From baseline to 18 months the change of restorations was evaluated