Clinical trial NCT03527953: A 24-month Clinical Evaluation of Different Bulk-fill Restorative Resins in Class II Restorations
Official title: Clinical Evaluation of Different Bulk-fill Restorative Resin Restorations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: bulk-fill restorative resins, dental caries
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-05-17
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Clinical evaluation of different restorative resins in class II cavities on posterior teeth according to the modified USPHS criteria
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: A.Ruya Yazici, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yazici AR, Antonson SA, Kutuk ZB, Ergin E. Thirty-Six-Month Clinical Comparison of Bulk Fill and Nanofill Composite Restorations. Oper Dent. 2017 Sep/Oct;42(5):478-485. doi: 10.2341/16-220-C. Epub 2017 Jun 5.