Sensitivity Clinical Trial
— EPSBNOfficial title:
Evaluation of Post-operative Sensitivity of Bulk Fill Resin Composite Versus the Nano Resin Composite.
NCT number | NCT03792178 |
Other study ID # | 150405 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 1, 2016 |
Est. completion date | April 25, 2017 |
Verified date | January 2019 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | April 25, 2017 |
Est. primary completion date | September 3, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 40 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Rasmia Mamdouh Ali Salem | World Health Organization |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | sensitivity | post operative sensitivity | one month follow up |
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