Clinical Comparison of Bulk-fill and Incremental Composite
1 other identifier
interventional
28
1 country
1
Brief Summary
The clinical performance of a 5-mm bulk-fill and an incremental resin composite in class II restorations will be evaluated and compared. After recruiting participants with at least 2 approximal caries lesions, all restorations will be placed by a single clinician. All caries lesions will be removed before restoring. Cavities will be divided into two groups: a 5 mm bulk-fill composite resin \[Filtek™ Bulk Fill Posterior, 3M ESPE, St. Paul MN, USA (FB)\] and an incremental posterior composite resin \[Filtek Ultimate Universal, 3M ESPE, St. Paul MN, USA (FU)\] All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after a week (baseline) 6, 12, 24, 36 and 48 months. Descriptive statistics will be performed using chi-square tests.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2018
Longer than P75 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
March 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedFirst Submitted
Initial submission to the registry
December 22, 2020
CompletedFirst Posted
Study publicly available on registry
December 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedFebruary 17, 2021
December 1, 2020
3 months
December 22, 2020
February 14, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical performances of different restorative systems according to USPHS criteria
Two year results according to USPHS criteria
two years
Study Arms (2)
Bulk-Fill
EXPERIMENTALFiltek™ Bulk Fill Posterior, 3M ESPE, St. Paul MN, USA (FB)
Incremental
EXPERIMENTALFiltek Ultimate Universal, 3M ESPE, St. Paul MN, USA (FU)
Interventions
Eligibility Criteria
You may qualify if:
- age range will be 18 to 65
- patients should have at least 2 approximal caries lesions require restoration
- healthy periodontal status
- a good likelihood of recall availability
You may not qualify if:
- poor gingival health
- adverse medical history
- potential behavioral problems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hacettepe University
Ankara, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc. Prof.
Study Record Dates
First Submitted
December 22, 2020
First Posted
December 28, 2020
Study Start
March 1, 2018
Primary Completion
June 1, 2018
Study Completion
June 1, 2022
Last Updated
February 17, 2021
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share