Evaluation of Post-operative Sensitivity of Bulk Fill Resin Composite Versus the Nano Resin Composite. (EPSBN)
Primary Purpose
Sensitivity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bulk fill composite
Nano resin composite
Sponsored by
About this trial
This is an interventional treatment trial for Sensitivity focused on measuring Post operative sensitivity
Eligibility Criteria
Inclusion Criteria:
- 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 .
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Nano resin composite
Bulk fill composite
Arm Description
are types of synthetic resins which are used in dentistry as restorative material or adhesives.
Bulk- ll composites are claimed to be restorative materials used in deep preparations and effectively photoactivated in layers up to 4 mm.
Outcomes
Primary Outcome Measures
sensitivity
post operative sensitivity
Secondary Outcome Measures
Full Information
NCT ID
NCT03792178
First Posted
January 1, 2019
Last Updated
January 3, 2019
Sponsor
Rasmia Mamdouh Ali Salem
Collaborators
World Health Organization
1. Study Identification
Unique Protocol Identification Number
NCT03792178
Brief Title
Evaluation of Post-operative Sensitivity of Bulk Fill Resin Composite Versus the Nano Resin Composite.
Acronym
EPSBN
Official Title
Evaluation of Post-operative Sensitivity of Bulk Fill Resin Composite Versus the Nano Resin Composite.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
September 3, 2016 (Actual)
Study Completion Date
April 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rasmia Mamdouh Ali Salem
Collaborators
World Health Organization
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Our results revealed that when the two composite types using self-etch adhesive system & total-etch adhesive system were evaluated; there was no statistically significant difference between the two composite types after 1 day, 1 week as well as 1 month.
When the two adhesive systems were compared using Bulk Fill composite & incremental Nano resin composite there was no statistically significant difference between the two adhesive systems after 1 day, 1 week as well as 1 month.
Using Bulk Fill composite with self-etch adhesive; there was a statistically significant decrease in prevalence of hypersensitivity after 1 week. There were no cases with hypersensitivity after 1 week as well as 1 month. Using Bulk Fill composite with Total etch adhesive; there was a statistically significant decrease in prevalence of hypersensitivity after 1 week as well as from 1 week to 1 month.
Using Incremental Nano resin composite with self-etch adhesive; there was a statistically significant decrease in prevalence of hypersensitivity after 1 week as well as from 1 week to 1 month. Using Incremental Nano resin composite with Total etch adhesive; there was a statistically significant decrease in prevalence of hypersensitivity after 1 week as well as from 1 week to 1 month.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensitivity
Keywords
Post operative sensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
bulk fill resin composite placement techqniues versus nano resin composite at postoperative hypersensitivity
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nano resin composite
Arm Type
Active Comparator
Arm Description
are types of synthetic resins which are used in dentistry as restorative material or adhesives.
Arm Title
Bulk fill composite
Arm Type
Experimental
Arm Description
Bulk- ll composites are claimed to be restorative materials used in deep preparations and effectively photoactivated in layers up to 4 mm.
Intervention Type
Other
Intervention Name(s)
Bulk fill composite
Intervention Description
Composite resin dental material
Intervention Type
Other
Intervention Name(s)
Nano resin composite
Intervention Description
Dental composite material
Primary Outcome Measure Information:
Title
sensitivity
Description
post operative sensitivity
Time Frame
one month follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 .
Exclusion Criteria:
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.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Evaluation of Post-operative Sensitivity of Bulk Fill Resin Composite Versus the Nano Resin Composite.
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