A 24-month Clinical Evaluation of Different Bulk-fill Restorative Resins in Class II Restorations
Clinical Evaluation of Different Bulk-fill Restorative Resin Restorations
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 5, 2018
CompletedFirst Posted
Study publicly available on registry
May 17, 2018
CompletedMay 17, 2018
May 1, 2018
2 years
May 5, 2018
May 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
2 years
Study Arms (3)
Tetric EvoCeram BulkFill resin
ACTIVE COMPARATORRandomly applied
Surefil SDR Flowable bulk-fill resin
ACTIVE COMPARATORRandomly applied
everX fiber-reinforced resin
ACTIVE COMPARATORRandomly applied
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hacettepe University
Ankara, 06100, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 28581919RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
A.Ruya Yazici, DDS, PhD
Hacettepe University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- single
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 5, 2018
First Posted
May 17, 2018
Study Start
November 1, 2013
Primary Completion
November 1, 2015
Study Completion
January 1, 2016
Last Updated
May 17, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share