Clinical Comparison of Bulk-fill Restorative and Nano-fill Resin Composite
Long-term Clinical Comparison of Bulk-fill and Nano-fill Composite Restorations
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
The aim of this study is to evaluate the clinical performance of a nano-fill and a bulk fill resin composite in class II restorations.
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 May 2013
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedFirst Submitted
Initial submission to the registry
March 22, 2020
CompletedFirst Posted
Study publicly available on registry
March 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedMarch 25, 2020
March 1, 2020
6.8 years
March 22, 2020
March 22, 2020
Conditions
Outcome Measures
Primary Outcomes (5)
Marginal adaptation
Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding marginal adaptation. Marginal adaptation will evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches will be performed . A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1: Harmonious outline Alpha 2: Marginal gap (max 100μ) with discoloration (removable) Bravo: Marginal gap (\> 100μ) with discoloration (unremovable) Charlie: The restoration is fractured or missed.
From baseline to 8 year the change of restorations will be evaluated
Marginal discoloration
Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding marginal discoloration. Marginal discoloration will be evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches will be performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth. Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.
From baseline to 8 year the change of restorations will be evaluated
Retention
Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate will be evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1:Clinically excellent Alpha 2: Clinically good with slight deviations from ideal performance, correction possible without damage of tooth or restoration Bravo: Clinically sufficient with few defects, corrections or repair of the restoration possible Charlie: Restoration is partially missed Delta: Restoration is totally missed
From baseline to 8 year the change of restorations will be evaluated
Anatomic form
Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding anatomic form. Anatomic form will be evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha 1: Continuous with existing anatomical form Alpha 2: Slightly discontinuous due to some chipping on the proximal ridge Bravo: Discontinuous with existing anatomical form due to material loss but proximal contact still present Charlie: Proximal contact is lost with ridge fracture.
From baseline to 8 year the change of restorations will be evaluated
Color change
Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding color change. Color changes will be evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failedand needs to be replaced. Alpha: The restoration matches the adjacent tooth structure in color and translucency. Bravo: Light mismatch in color, shade or translucency between the restoration and the adjacent tooth. Charlie: The mismatch in color and translucency is outside the acceptable range of tooth color and translucency.
From baseline to 8 year the change of restorations will be evaluated
Study Arms (2)
Bulk-fill resin composite
EXPERIMENTALBulk-fill resin composite will be places with bulk technique.
Nano-fill resin composite
ACTIVE COMPARATORNano-fill resin composite will be placed with 2 mm thickness layering technique.
Interventions
Eligibility Criteria
You may qualify if:
- a need for at least two but not more than four posterior tooth-colored restorations
- the presence of teeth to be restored in occlusion
- teeth that were symptomless and vital
- a normal periodontal status
- a good likelihood of recall availability.
You may not qualify if:
- partly erupted teeth
- absence of adjacent and antagonist teeth
- poor periodontal status
- adverse medical history
- potential behavioral problems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ayse R Yazici, DDS, PhD
Hacettepe University School of Dentistry
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 22, 2020
First Posted
March 25, 2020
Study Start
May 1, 2013
Primary Completion
February 1, 2020
Study Completion
May 1, 2025
Last Updated
March 25, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share