Clinical Comparison of Bulk-fill Restorative and Nano-fill Resin Composite
Primary Purpose
Dental Caries
Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bulk-fill
Nano-fill
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- partly erupted teeth
- absence of adjacent and antagonist teeth
- poor periodontal status
- adverse medical history
- potential behavioral problems
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bulk-fill resin composite
Nano-fill resin composite
Arm Description
Bulk-fill resin composite will be places with bulk technique.
Nano-fill resin composite will be placed with 2 mm thickness layering technique.
Outcomes
Primary Outcome Measures
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.
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.
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
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04320576
Brief Title
Clinical Comparison of Bulk-fill Restorative and Nano-fill Resin Composite
Official Title
Long-term Clinical Comparison of Bulk-fill and Nano-fill Composite Restorations
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2013 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
May 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
In accordance with a split-mouth design, 50 patients will be received at least one pair of restorations, restored with a nanofill resin composite (Filtek Ultimate [FU]) and with a bulk fill resin composite (Tetric EvoCeram Bulk Fill [TB]). Each restorative resin will be used with its respective adhesive system according to the manufacturers' instructions. A total of 104 class II restorations will be placed by two operators. The restorations will be blindly evaluated by two examiners at baseline and at 1-, 2-, 3-, 4-, 5-, 6-, 7- and 8- year using modified US Public Health Service Ryge criteria. The comparison of the two restorative materials for each category will be performed with the chi-square test (a=0.05). The baseline scores will be compared with those at the recall visits using the Cochran Q-test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bulk-fill resin composite
Arm Type
Experimental
Arm Description
Bulk-fill resin composite will be places with bulk technique.
Arm Title
Nano-fill resin composite
Arm Type
Active Comparator
Arm Description
Nano-fill resin composite will be placed with 2 mm thickness layering technique.
Intervention Type
Device
Intervention Name(s)
Bulk-fill
Intervention Description
Bulk-fill resin composite (bulk technique)
Intervention Type
Device
Intervention Name(s)
Nano-fill
Intervention Description
Nano-fill resin composite (layering technique)
Primary Outcome Measure Information:
Title
Marginal adaptation
Description
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.
Time Frame
From baseline to 8 year the change of restorations will be evaluated
Title
Marginal discoloration
Description
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.
Time Frame
From baseline to 8 year the change of restorations will be evaluated
Title
Retention
Description
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
Time Frame
From baseline to 8 year the change of restorations will be evaluated
Title
Anatomic form
Description
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.
Time Frame
From baseline to 8 year the change of restorations will be evaluated
Title
Color change
Description
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.
Time Frame
From baseline to 8 year the change of restorations will be evaluated
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
partly erupted teeth
absence of adjacent and antagonist teeth
poor periodontal status
adverse medical history
potential behavioral problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayse R Yazici, DDS, PhD
Organizational Affiliation
Hacettepe University School of Dentistry
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/28581919
Description
PUBMED
URL
https://www.ncbi.nlm.nih.gov/pubmed/29630489
Description
PUBMED
Learn more about this trial
Clinical Comparison of Bulk-fill Restorative and Nano-fill Resin Composite
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