Clinical Evaluation of Extensive Direct Composite Restorations With Polyethylene Fiber

Not Applicable

Completed

• Conditions: Dental Caries Extending Into Dentin
• Interventions: Device: Genial Posterior Composite with Polyethylene Fiber; Device: Genial Posterior Composite

• Registration Number: NCT04612543
• Lead Sponsor: Kafkas University

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.

Study Timeline

• Study Start: 2019-02-10
• Primary Completion: 2020-08-10
• Study Completion: 2020-08-31
• Status Verified: 2020-10
• Study First Submitted: 2020-10-26
• Study First Submitted QC: 2020-10-27
• Last Update Submitted: 2020-10-27
• Study First Posted: 2020-11-03
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

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Exclusion Criteria

• partly erupted teeth;

  -.absence of adjacent and antagonist teeth

• poor periodontal status;

• adverse medical history;

• potential behavioral problems.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Genial Posterior Composite	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
Genial Posterior Composite	Genial Posterior Composite with Polyethylene Fiber	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
Genial Posterior Composite with Polyethylene fiber	Genial Posterior Composite with Polyethylene Fiber	The enamel and dentin were conditioned with bonding procedure.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 with Polyethylene fiber	Genial Posterior Composite	The enamel and dentin were conditioned with bonding procedure.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.

Primary Outcome Measures

Name	Time	Method
anatomic form	From baseline to 18 months the change of restorations was evaluated	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.
Marginal adaptation	From baseline to 18 months the change of restorations was evaluated	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)
marginal discoloration	From baseline to 18 months the change of restorations was evaluated	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
retention rate	From baseline to 18 months the change of restorations was evaluated	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
color change	From baseline to 18 months the change of restorations was evaluated	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

Trial Locations

Locations (1)

Kafkas University School of Dentistry; 🇹🇷 Kars, Turkey