Comparative Evaluation of Short Fiber-Reinforced Composite and Bulk fill Resin Composite Restoration in Primary Posterior Teeth: An in Vivo Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- The primary outcome will be clinically evaluated under the USPHS criteria (marginal adapatation post operative sensitivity surface texture secondary caries) by comparing the restorations done on the class I cavity between group I - Ever X Flow composite and group II-Tetric N Ceram composite
Study Overview
Brief Summary
Direct restorations have been largely employed to restore posterior teeth due to their low cost when compared to indirect restorations, along with acceptable clinical performance.Resin composite restorations in the high stress-bearing area led to some common failures that are secondary caries, marginal leakage, and post-operative sensitivity. To overcome the weakness of the resin composites manufacturers developed short fiber-reinforced composites (SFRC). They are dentine replacing material in posterior high stress-bearing restorations, especially molars. The material also revealed control in polymerization shrinkage stress by fiber orientation reducing the microleakage compared with that of the composites.The resin matrix contains inorganic particulate fillers and short glass fibers that provide three-directional reinforcement. Since most of the studies have focused on evaluating SFRC in permanent teeth, there are very few studies done on primary teeth. Thus, this study aims to evaluate the clinical performance (marginal adaptation, postoperative sensitivity, development of secondary caries, and surface texture) of composite restorations restored by short fiber-reinforced composite and bulk-fill resin composite.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 6.00 Year(s) to 10.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Cooperative children.
- •2.Vital primary molars.
- •3.Patients with a good likelihood of recall availability.
- •4.Teeth without any symptoms.
- •5.Class I cavities only (occlusal surface).
Exclusion Criteria
- •Medically compromised children.
- •Extensive carious lesions.
- •Suspected of any drug or restorative material allergy.
- •Potential behavioral disorders.
- •Radiographic indication of pulp involvement.
Outcomes
Primary Outcomes
The primary outcome will be clinically evaluated under the USPHS criteria (marginal adapatation post operative sensitivity surface texture secondary caries) by comparing the restorations done on the class I cavity between group I - Ever X Flow composite and group II-Tetric N Ceram composite
Time Frame: 3 months & 6 months
Secondary Outcomes
- The study will compare the good clinical performance between two composites materials suitable for restoring the primary molars(1 YEAR)
Investigators
Dr Prabha Shree
THE OXFORD DENTAL COLLEGE BANGALORE INDIA