Clinical Evaluation of Extensive Direct Composite Restorations With Polyethylene Fiber

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Genial Posterior Composite with Polyethylene Fiber

Genial Posterior Composite

About this trial

This is an interventional treatment trial for Dental Caries Extending Into Dentin focused on measuring Composite resin, Clinical Evaluation, Polyethylene Fiber, First Permanent Molars, Extensive carious

Eligibility Criteria

9 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Kafkas University School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Genial Posterior Composite with Polyethylene fiber

Genial Posterior Composite

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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)

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

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

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.

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04612543

First Posted

October 26, 2020

Last Updated

October 27, 2020

Sponsor

Kafkas University

1. Study Identification

Unique Protocol Identification Number

NCT04612543

Brief Title

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

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

February 10, 2019 (Actual)

Primary Completion Date

August 10, 2020 (Actual)

Study Completion Date

August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kafkas University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries Extending Into Dentin

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Genial Posterior Composite with Polyethylene fiber

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Genial Posterior Composite

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Genial Posterior Composite with Polyethylene Fiber

Other Intervention Name(s)

Micro hybrid composite with Polyethylene Fiber

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Genial Posterior Composite

Other Intervention Name(s)

Micro hybrid composite

Intervention Description

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

Primary Outcome Measure Information:

Title

Marginal adaptation

Description

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)

Time Frame