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

Primary Purpose

Dental Caries

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Tetric EvoCeram Bulkfill
Surefil SDR Flowable bulkfill
everX fiber-reinforced resin
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring bulk-fill restorative resins, dental caries

Eligibility Criteria

20 Years - 41 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Tetric EvoCeram BulkFill resin

Surefil SDR Flowable bulk-fill resin

everX fiber-reinforced resin

Arm Description

Randomly applied

Randomly applied

Randomly applied

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 5, 2018
Last Updated
May 5, 2018
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT03527953
Brief Title
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
November 2013 (Actual)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
bulk-fill restorative resins, dental caries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
single
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tetric EvoCeram BulkFill resin
Arm Type
Active Comparator
Arm Description
Randomly applied
Arm Title
Surefil SDR Flowable bulk-fill resin
Arm Type
Active Comparator
Arm Description
Randomly applied
Arm Title
everX fiber-reinforced resin
Arm Type
Active Comparator
Arm Description
Randomly applied
Intervention Type
Other
Intervention Name(s)
Tetric EvoCeram Bulkfill
Intervention Description
The preparation will be etched with 37% phosphoric acid. It will be then rinsed with an air-water spray and dried, leaving the dentin slightly moist. An etch-and-rinse adhesive, ExciTE F, will be applied and agitated on the prepared surfaces for at least 10 seconds. The adhesive will be air-thinned and light-cured for 20 seconds with an LED curing unit. The sectional matrix will be placed and fixed with wooden wedges. Then the bulk-fill resin composite, TBF, will be placed in bulk in about 4-mm thickness and then will be cured for 20 seconds.
Intervention Type
Other
Intervention Name(s)
Surefil SDR Flowable bulkfill
Intervention Description
The preparation will be etched. A two-step etch-and-rinse adhesive, Prime&Bond NT will be applied to all enamel/dentin surfaces, air-dried for 5 seconds, and will be light cured for 10 seconds. After the sectional matrix will be placed, the flowable bulk-fill resin composite, SureFil SDR™ flow (Dentsply Caulk, Milford, DE, USA), will be placed in a 4-mm bulk increment in the dentinal part cured for 20 seconds and will be followed by a covering layer of the nanohybrid resin composite, Ceram.X Mono that will be cured for 20 seconds.
Intervention Type
Other
Intervention Name(s)
everX fiber-reinforced resin
Intervention Description
The enamel will be etched with 37% phosphoric acid for 10 seconds, then will be rinsed, and dried with an air/water syringe for at least 5 seconds. Self-etch adhesive, G-aenial Bond (GC Co., Tokyo, Japan), will be applied to all enamel/dentin surfaces and gently air thinned and then will be light cured for 10 seconds. After the matrix will be placed and wedged, mesial or distal walls will be built with 1-2-mm layers of G-aenial Posterior resin composite. The fiber-reinforced composite, everX Posterior, will be placed into the cavity in approximately 4-mm thickness. The last 2 mm of the cavity will be restored using the G-aenial Posterior composite as an overlay layer. Each increment will be light cured for 20 seconds using an LED unit.
Primary Outcome Measure Information:
Title
Clinical evaluation of different restorative resins in class II cavities on posterior teeth according to the modified USPHS criteria
Description
Long-term clinical success of different restorative resins in class II cavities on posterior teeth
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A.Ruya Yazici, DDS, PhD
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28581919
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.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/28581919?report=abstract
Description
PubMed

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

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