- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04565860
Clinical Evaluation of Bulk-fill Composite Resins in Class II Restorations
Erciyes University Clinical Research Ethics Committee
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kayseri, Turkey
- Nuh Naci Yazgan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- At least 4 Class-II caries lesions
- Good health
- Acceptable level of oral hygiene
Exclusion Criteria:
- Did not have four caries lesions at least
- Did not have Class-II caries lesions
- Deep caries reaching the pulp
- The patients are not 18-20 years old
- Bruxism
- Periodontal disease
- Refused to participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: X-tra fil (bulk-filling) (X-traB)
X-tra fil composite placed as bulk-filling
|
Bulk-fill composites that were introduced in recent years are dental filling materials. Traditionally, the composite resins are placed in increments of 2 mm that are cured separately (incremental technique). Bulk-fill composites can be described as composites that are sufficiently polymerizable in a single layer up to 4 mm thick. In this study, each bulk-fill composite resin was used both in bulk-filing and incremental techniques for the same patient. The study set to 4 groups and 20 restorations in each group (a total of 80 restorations).
Other Names:
|
Active Comparator: X-tra fil (incremental) (X-traI)
X-tra fil composite placed as incremental
|
Bulk-fill composites that were introduced in recent years are dental filling materials. Traditionally, the composite resins are placed in increments of 2 mm that are cured separately (incremental technique). Bulk-fill composites can be described as composites that are sufficiently polymerizable in a single layer up to 4 mm thick. In this study, each bulk-fill composite resin was used both in bulk-filing and incremental techniques for the same patient. The study set to 4 groups and 20 restorations in each group (a total of 80 restorations).
Other Names:
|
Active Comparator: Filtek Bulk (bulk-filling) (FBB)
Filtek Bulk composite placed as bulk-filling
|
Bulk-fill composites that were introduced in recent years are dental filling materials. Traditionally, the composite resins are placed in increments of 2 mm that are cured separately (incremental technique). Bulk-fill composites can be described as composites that are sufficiently polymerizable in a single layer up to 4 mm thick. In this study, each bulk-fill composite resin was used both in bulk-filing and incremental techniques for the same patient. The study set to 4 groups and 20 restorations in each group (a total of 80 restorations).
Other Names:
|
Active Comparator: Filtek Bulk (incremental) (FBI)
Filtek Bulk composite placed as incremental
|
Bulk-fill composites that were introduced in recent years are dental filling materials. Traditionally, the composite resins are placed in increments of 2 mm that are cured separately (incremental technique). Bulk-fill composites can be described as composites that are sufficiently polymerizable in a single layer up to 4 mm thick. In this study, each bulk-fill composite resin was used both in bulk-filing and incremental techniques for the same patient. The study set to 4 groups and 20 restorations in each group (a total of 80 restorations).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the clinical performance of bulk-fill composite about placement technique (bulk-filling and incremental) in Class II carious lesions using FDI and USPHS criteria.
Time Frame: Two-year
|
FDI; The World Dental Federation.
USPHS; The United States Public Health Service.
The 2-year results of the restorations were evaluated with the FDI and USPHS criteria.
Two calibrated observers who were blinded to the objective of this study performed the evaluations.
|
Two-year
|
Evaluation of the clinical performance of bulk-fill composite about placement technique (bulk-filling and incremental) in Class II carious lesions using FDI and USPHS criteria.
Time Frame: Four-year
|
FDI; The World Dental Federation.
USPHS; The United States Public Health Service.
The 4-year results of the restorations were evaluated with the FDI and USPHS criteria.
Two calibrated observers who were blinded to the objective of this study performed the evaluations.
|
Four-year
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2015/281
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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