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

Not Applicable

Completed

• Conditions: Dental Caries
• Interventions: Other: Tetric EvoCeram Bulkfill; Other: everX fiber-reinforced resin; Other: Surefil SDR Flowable bulkfill

• Registration Number: NCT03527953
• Lead Sponsor: Hacettepe University

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 Timeline

• Study Start: 2013-11
• Primary Completion: 2015-11
• Study Completion: 2016-01
• Status Verified: 2018-05
• Study First Submitted: 2018-05-05
• Study First Submitted QC: 2018-05-05
• Last Update Submitted: 2018-05-05
• Study First Posted: 2018-05-17
• Last Update Posted: 2018-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tetric EvoCeram BulkFill resin	Tetric EvoCeram Bulkfill	Randomly applied
everX fiber-reinforced resin	everX fiber-reinforced resin	Randomly applied
Surefil SDR Flowable bulk-fill resin	Surefil SDR Flowable bulkfill	Randomly applied

Primary Outcome Measures

Name	Time	Method
Clinical evaluation of different restorative resins in class II cavities on posterior teeth according to the modified USPHS criteria	2 years	Long-term clinical success of different restorative resins in class II cavities on posterior teeth

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Turkey