Three-Year Clinical Evaluation of Class II Posterior Composite Restorations
Primary Purpose
Dental Caries
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Aelite Flo
x-tra base
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries focused on measuring composite resin, bulk-fill, teeth endodontically-treated
Eligibility Criteria
Inclusion Criteria:
- Permanent premolars and molars without any restorations were included in the study. Every tooth included in the study had neighboring teeth and were in occlusion to antagonistic teeth.
Exclusion Criteria:
- Patients were excluded who needed indirect restorations due to significant loss of tooth structure, known allergies to product ingredients, had poor oral hygiene and a history of bruxism.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Aelite Flo
x-tra base
Arm Description
Microhybrid flowable composite
Bulk-fill flowable composite
Outcomes
Primary Outcome Measures
Clinical performance evaluation of different composite resin restorations with USPHS criteria
Every year in three years period
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02858947
Brief Title
Three-Year Clinical Evaluation of Class II Posterior Composite Restorations
Official Title
Three-Year Clinical Evaluation of Class II Posterior Composite Restorations Placed With Different Techniques and Flowable Composite Linings in Endodontically Treated Teeth
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ondokuz Mayıs University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study was to investigate the clinical effectiveness of direct resin composite restorations placed with different placement techniques (incremental or bulk) and with different flowable linings (conventional or bulk-fill flowable) used in open-sandwich technique, in endodontically treated Class II cavities (mesio-occlusal or disto-occlusal), in a randomized controlled comparison.
Detailed Description
Forty-seven pairs Class II (mesio-occlusal or disto-occlusal) composite restorations were placed in 37 patients. In all cavities, Adper Single Bond 2 was used. In one of the cavities of each pair, a conventional flowable composite, Aelite Flo, was applied in approximately 2mm thick, and the remaining cavity was restored incrementally with GrandioSO. In the second cavity, a bulk-fill flowable composite, x-tra base, was applied in approximately 4 mm thick in bulk increments and the remaining 2mm occlusal part of the cavity was restored with GrandioSO. All cavities were restored with open-sandwich technique by the same operator. At baseline and after 6-month, 1-, 2- and 3-year follow-up visits, restorations were evaluated by Modified USPHS criteria.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
composite resin, bulk-fill, teeth endodontically-treated
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aelite Flo
Arm Type
Active Comparator
Arm Description
Microhybrid flowable composite
Arm Title
x-tra base
Arm Type
Active Comparator
Arm Description
Bulk-fill flowable composite
Intervention Type
Procedure
Intervention Name(s)
Aelite Flo
Other Intervention Name(s)
1000006652
Intervention Description
Microhybrid flowable composite
Intervention Type
Procedure
Intervention Name(s)
x-tra base
Other Intervention Name(s)
1145403
Intervention Description
Bulk-fill flowable composite
Primary Outcome Measure Information:
Title
Clinical performance evaluation of different composite resin restorations with USPHS criteria
Description
Every year in three years period
Time Frame
three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Permanent premolars and molars without any restorations were included in the study. Every tooth included in the study had neighboring teeth and were in occlusion to antagonistic teeth.
Exclusion Criteria:
Patients were excluded who needed indirect restorations due to significant loss of tooth structure, known allergies to product ingredients, had poor oral hygiene and a history of bruxism.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Three-Year Clinical Evaluation of Class II Posterior Composite Restorations
We'll reach out to this number within 24 hrs