A 24-month Clinical Evaluation of Different Bulk-fill Restorative Resins in Class II Restorations

H

Hacettepe University

Status

Completed

Conditions

Dental Caries

Treatments

Other: everX fiber-reinforced resin
Other: Tetric EvoCeram Bulkfill
Other: Surefil SDR Flowable bulkfill

Study type

Interventional

Funder types

Other

Identifiers

NCT03527953
71146310

Details and patient eligibility

About

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.

Full 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).

Enrollment

40 patients

Sex

All

Ages

20 to 41 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 3 patient groups

Tetric EvoCeram BulkFill resin
Active Comparator group
Description:
Randomly applied
Treatment:
Other: Tetric EvoCeram Bulkfill
Surefil SDR Flowable bulk-fill resin
Active Comparator group
Description:
Randomly applied
Treatment:
Other: Surefil SDR Flowable bulkfill
everX fiber-reinforced resin
Active Comparator group
Description:
Randomly applied
Treatment:
Other: everX fiber-reinforced resin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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