Evaluation of Post-operative Sensitivity of Bulk Fill Resin Composite Versus the Nano Resin Composite.
EPSBN
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
Our study evaluated and compared the postoperative sensitivity of the placement technique (incremental and bulk fill) in class II posterior composite resin restorations bonded with two different adhesive strategies (self-etch and etch-and-rinse).Sixty patients were randomly selected, their age range from 25 to 40 years old. They were divided into 2 main groups according to the packing technique of composite material; incremental Tetric Evoceram and Tetric Evoceram bulk fill composite.30 patients (n=30) were selected for incremental Tetric Evoceram composite restorations and they were equally divided according to the adhesive systems used (etch and rinse or self-etch adhesive strategy) (n=15 teeth).30 patients (n=30) were selected for Tetric Evoceram bulk fill composite restorations and they were equally divided according to the adhesive systems used (etch and rinse or self-etch adhesive strategy) (n=15 teeth).Post-operative pain assessed at 24 hours, 1 week and 1 month using the visual Analog Scale Score (VAS).Each patient was instructed to place a vertical mark on the VAS line at home to indicate the intensity of pain at each assessment period.
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 Sep 2016
Shorter than P25 for not_applicable
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
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 3, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2017
CompletedFirst Submitted
Initial submission to the registry
January 1, 2019
CompletedFirst Posted
Study publicly available on registry
January 3, 2019
CompletedJanuary 7, 2019
January 1, 2019
2 days
January 1, 2019
January 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
sensitivity
post operative sensitivity
one month follow up
Study Arms (2)
Nano resin composite
ACTIVE COMPARATORare types of synthetic resins which are used in dentistry as restorative material or adhesives.
Bulk fill composite
EXPERIMENTALBulk- ll composites are claimed to be restorative materials used in deep preparations and effectively photoactivated in layers up to 4 mm.
Interventions
Eligibility Criteria
You may qualify if:
- Patients must show no signs of spontaneous dental or orofacial pain.
- The presence of molar and premolar class II teeth requiring composite restorations for the treatment of primary carious lesions
- The selected teeth should have an occlusal contact with natural or crowned antagonist teeth
- The selected teeth should have a proximal contact with the adjacent teeth.
- Shallow and mid-sized cavity depths will be included in the study .
You may not qualify if:
- Increasing pre-operative sensitivity of the selected teeth.
- Teeth with abnormal periapical anatomy or caries that will be likely to result in very deep restorations.
- Teeth with old restorations or severely destructed dental crowns.
- Teeth with spontaneous pain
- Tempro-mandibular joint problems involving symptomatic pain.
- Patients taking analgesics that could alter their normal pain perception level.
- Pregnancy or breast feeding, acute and chronic systemic diseases, immunecompromised patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rasmia Mamdouh Ali Salemlead
- World Health Organizationcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant lecturer at operative Department
Study Record Dates
First Submitted
January 1, 2019
First Posted
January 3, 2019
Study Start
September 1, 2016
Primary Completion
September 3, 2016
Study Completion
April 25, 2017
Last Updated
January 7, 2019
Record last verified: 2019-01