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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
Rasmia Mamdouh Ali Salem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sensitivity focused on measuring Post operative sensitivity

Eligibility Criteria

25 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 1, 2019
    Last Updated
    January 3, 2019
    Sponsor
    Rasmia Mamdouh Ali Salem
    Collaborators
    World Health Organization
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    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

    Learn more about this trial

    Evaluation of Post-operative Sensitivity of Bulk Fill Resin Composite Versus the Nano Resin Composite.

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