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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03527953
Recruitment Status : Completed
First Posted : May 17, 2018
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
A Ruya Yazici, Hacettepe University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dental Caries Other: Tetric EvoCeram Bulkfill Other: Surefil SDR Flowable bulkfill Other: everX fiber-reinforced resin Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: single
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Different Bulk-fill Restorative Resin Restorations
Actual Study Start Date : November 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Tetric EvoCeram BulkFill resin
Randomly applied
 Other: Tetric EvoCeram Bulkfill
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.
Active Comparator: Surefil SDR Flowable bulk-fill resin
Randomly applied
 Other: Surefil SDR Flowable bulkfill
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.
Active Comparator: everX fiber-reinforced resin
Randomly applied
 Other: everX fiber-reinforced resin
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 41 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03527953


Locations
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Turkey
Hacettepe University
Ankara, Turkey, 06100
Sponsors and Collaborators
Hacettepe University
Investigators
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Principal Investigator: A.Ruya Yazici, DDS, PhD Hacettepe University
More Information
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Additional Information:
PubMed  This link exits the ClinicalTrials.gov site

Publications of Results:

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Responsible Party: A Ruya Yazici, Professor, Hacettepe University
ClinicalTrials.gov Identifier: NCT03527953    
Other Study ID Numbers: 71146310
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by A Ruya Yazici, Hacettepe University:
bulk-fill restorative resins, dental caries
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases