Clinical Evaluation of Different Bulk-fill Restorative Resin Restorations
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hacettepe University
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Clinical evaluation of different restorative resins in class II cavities on posterior teeth according to the modified USPHS criteria
Study Overview
Brief Summary
The aim of this study is to evaluate the clinical performance of three different bulk-fill restorative resin materials; a bulk fill resin composite, a flowable bulk fill resin composite and a fiber-reinforced resin in Class II restorations over a period of 24 months.
Detailed Description
The objective of this study is to evaluate the 24-month clinical performance of three different bulk-fill restorative resin materials in Class II restorations. Forty patients with at least three approximal lesions in premolar and molar teeth will be participated in the study. A total of 120 Class II cavities will be restored using Tetric EvoCeram Bulk Fill (n=40), SureFil SDR flow + Ceram X mono (n=40), and everX Posterior + G-aenial Posterior (n=40) with their respective adhesives according to the manufacturers' instructions. All restorations will be placed by one operator. The restorations will be evaluated at baseline and at 6, 12, 18, and 24 months using modified USPHS criteria by one examiner. The restoration groups for each category will be compared using Pearson's chi-square test, while Cochran's Q test will be used to compare the changes across different time points within each restorative material (p<0.05).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
single
Eligibility Criteria
- Ages
- 20 Years to 41 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients who accept to participate and sign the informed consent
- •Patients who have at least three similar-sized approximal primary caries lesions in premolar and molar teeth.
- •The teeth to be restored had a normal occlusal relationship with natural dentition and had adjacent tooth contact and had a normal response to a vitality test with no periapical pathology
Exclusion Criteria
- •Patients who don't accept to participate and sign the informed consent
- •Patients who have a history of adverse reaction to the test materials
- •Patients who are pregnant or lactating, have fewer than 20 teeth
- •Patients who have poor oral hygiene, have severe or chronic periodontal disease, have heavy bruxism
Arms & Interventions
Tetric EvoCeram BulkFill resin
Randomly applied
Intervention: Tetric EvoCeram Bulkfill (Other)
Surefil SDR Flowable bulk-fill resin
Randomly applied
Intervention: Surefil SDR Flowable bulkfill (Other)
everX fiber-reinforced resin
Randomly applied
Intervention: everX fiber-reinforced resin (Other)
Outcomes
Primary Outcomes
Clinical evaluation of different restorative resins in class II cavities on posterior teeth according to the modified USPHS criteria
Time Frame: 2 years
Long-term clinical success of different restorative resins in class II cavities on posterior teeth
Secondary Outcomes
No secondary outcomes reported
Investigators
A Ruya Yazici
Professor
Hacettepe University