Randomized, Controlled Clinical Evaluation of Extensive Direct Composite Restorations With Polyethylene Fiber in the First Permanent Molars of Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Kafkas University
- Enrollment
- 75
- Locations
- 2
- Primary Endpoint
- anatomic form
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 9 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
anatomic form
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported
Investigators
Semanur Özüdoğru
Assistant Professor
Kafkas University