Clinical Evaluation of Extensive Direct Composite Restorations With Polyethylene Fiber

NCT04612543 | Completed DMC

• 1 other identifier: KafkasU
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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).

Conditions

Dental Caries Extending Into Dentin

Keywords

Composite resin; Clinical Evaluation; Polyethylene Fiber; First Permanent Molars; Extensive carious

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Genial Posterior Composite with Polyethylene fiber

ACTIVE COMPARATOR

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.

Device: Genial Posterior Composite with Polyethylene Fiber; Device: Genial Posterior Composite

Genial Posterior Composite

ACTIVE COMPARATOR

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

Device: Genial Posterior Composite with Polyethylene Fiber; Device: Genial Posterior Composite

Interventions

Genial Posterior Composite with Polyethylene Fiber DEVICE

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.

Also known as: Micro hybrid composite with Polyethylene Fiber

Genial Posterior Composite; Genial Posterior Composite with Polyethylene fiber

Genial Posterior Composite DEVICE

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

Also known as: Micro hybrid composite

Genial Posterior Composite; Genial Posterior Composite with Polyethylene fiber

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• partly erupted teeth;
• absence of adjacent and antagonist teeth
• poor periodontal status;
• adverse medical history;
• potential behavioral problems.

Sponsors & Collaborators

• Kafkas University: lead

Study Sites (1)

Kafkas University School of Dentistry

Kars, 36000, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 28467261 BACKGROUND

• 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.

  PMID: 24579274 BACKGROUND

• 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.

  PMID: 16414110 BACKGROUND

Study Officials

• SEMANUR ÖZÜDOĞRU, Ass.. Prof

  Kafkas University School of Dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 3, 2020
• Study Start: February 10, 2019
• Primary Completion: August 10, 2020
• Study Completion: August 31, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)