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Postoperative Pain Following Restoration With Composite Resin Versus Sonic Fill

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sonic Fill Restoration
Composite Resin Restoration
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring First Permanent Molar, Composite, Sonic Fill, Resin Restoration, Pediatric Dentistry

Eligibility Criteria

6 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Asymptomatic First Permanent Molar
  • Age of the patient ranging from 6-9 years
  • Normal periodontal status
  • Teeth with no previous restorative treatment
  • Good oral health
  • Absences of pathological mobility

Exclusion Criteria:

  • Adverse medical history
  • Potential behavioral problems
  • Parents refusing participation of their children

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Sonic Fill Restoration

    Composite Resin Restoration

    Arm Description

    Using sonic activation system turns the highly filled sonic fill composite into a flowable which enables the material to rapidly fill the cavity effortlessly- greatly reducing procedure time.

    Direct composite restorations are the most requested and performed dental procedures. The incremental placement technique is the gold standard for posterior universal composite placement.

    Outcomes

    Primary Outcome Measures

    Postoperative Pain
    The primary outcome (postoperative pain) is evaluated the following day of the treatment performed by a phone call from the outcome assessor, a week and a month after to check in any pain.

    Secondary Outcome Measures

    Clinical Evaluation of Restoration (Modified USPHS Criteria)
    The secondary outcome (USPHS) is evaluated by the outcome assessor and an investigator using the given scores as follows: The modified United States Public Health Service (USPHS) criteria for retention, color matching, marginal discoloration, marginal adaptation, secondary caries, surface texture and anatomical form were used.

    Full Information

    First Posted
    March 11, 2020
    Last Updated
    July 14, 2020
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04307420
    Brief Title
    Postoperative Pain Following Restoration With Composite Resin Versus Sonic Fill
    Official Title
    Postoperative Pain Following Restoration With Sonic Fill Versus Composite Resin in Children With Deep Carious First Permanent Molar: A Randomized Clinical Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2020 (Anticipated)
    Primary Completion Date
    May 31, 2021 (Anticipated)
    Study Completion Date
    June 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The aim of this study is to assess the postoperative pain following restoration with composite resin versus sonic fill in children with deep carious first permanent molar.
    Detailed Description
    For many years, composite resin restorations have been considered an acceptable treatment choice for anterior applications. Recent advances in composite resin mechanical properties and improved adhesive systems have broadened the application of these materials to include the restoration of posterior teeth. However, it is still generally accepted that posterior composite resin restorations have limitations and that there is no ideal material available. A volumetric shrinkage occurs when a composite resin material is cured. The shrinkage is the result of conversion of monomer molecules into a more dense polymer network, which leads to bulk contraction. A new nanohybrid composite activated by sonic energy has been recently introduced as a single-step, bulk-fill restorative material. This system utilizes the patented sonic-activation technology enabling a rapid flow of composite into the cavity for effortless placement and superior adaptation in one single layer, thereby, emphasizes its practical and efficient technique for placing posterior composites. The hand piece, designed by KaVo (Germany), delivers sonic energy at varying intensities, which is adjusted on the shank from low to high (1 to 5) to control rate of composite extrusion.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain
    Keywords
    First Permanent Molar, Composite, Sonic Fill, Resin Restoration, Pediatric Dentistry

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    32 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sonic Fill Restoration
    Arm Type
    Experimental
    Arm Description
    Using sonic activation system turns the highly filled sonic fill composite into a flowable which enables the material to rapidly fill the cavity effortlessly- greatly reducing procedure time.
    Arm Title
    Composite Resin Restoration
    Arm Type
    Active Comparator
    Arm Description
    Direct composite restorations are the most requested and performed dental procedures. The incremental placement technique is the gold standard for posterior universal composite placement.
    Intervention Type
    Procedure
    Intervention Name(s)
    Sonic Fill Restoration
    Intervention Description
    Kerr's Sonic Fill is the only sonic-activated, single-step, bulk-fill composite that starts out as a low-viscosity composite.
    Intervention Type
    Procedure
    Intervention Name(s)
    Composite Resin Restoration
    Intervention Description
    Composite resins are polymer-based materials used in dentistry for aesthetic repairs.Polymerization is accomplished typically with a hand held curing light that emits specific wavelengths keyed to the initiator and catalyst packages involved.
    Primary Outcome Measure Information:
    Title
    Postoperative Pain
    Description
    The primary outcome (postoperative pain) is evaluated the following day of the treatment performed by a phone call from the outcome assessor, a week and a month after to check in any pain.
    Time Frame
    Baseline
    Secondary Outcome Measure Information:
    Title
    Clinical Evaluation of Restoration (Modified USPHS Criteria)
    Description
    The secondary outcome (USPHS) is evaluated by the outcome assessor and an investigator using the given scores as follows: The modified United States Public Health Service (USPHS) criteria for retention, color matching, marginal discoloration, marginal adaptation, secondary caries, surface texture and anatomical form were used.
    Time Frame
    3 months, 6 months, 9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    9 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Asymptomatic First Permanent Molar Age of the patient ranging from 6-9 years Normal periodontal status Teeth with no previous restorative treatment Good oral health Absences of pathological mobility Exclusion Criteria: Adverse medical history Potential behavioral problems Parents refusing participation of their children
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mennatallah S Maklad, Masters
    Phone
    +201015556040
    Email
    menna.maklad@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fatma K Abdelgawad, Professor
    Phone
    +201006753265
    Email
    fatmadent@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nevine Waly, Profesor
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29430088
    Citation
    Chandrasekhar V, Rudrapati L, Badami V, Tummala M. Incremental techniques in direct composite restoration. J Conserv Dent. 2017 Nov-Dec;20(6):386-391. doi: 10.4103/JCD.JCD_157_16.
    Results Reference
    background
    PubMed Identifier
    31592052
    Citation
    Afifi SMH, Haridy MF, Farid MR. Evaluation of Post-Operative Sensitivity of Bulk Fill Resin Composite versus Nano Resin Composite: A Randomized Controlled Clinical Study. Open Access Maced J Med Sci. 2019 Jul 26;7(14):2335-2342. doi: 10.3889/oamjms.2019.656. eCollection 2019 Jul 30.
    Results Reference
    background
    PubMed Identifier
    28849804
    Citation
    Atabek D, Aktas N, Sakaryali D, Bani M. Two-year clinical performance of sonic-resin placement system in posterior restorations. Quintessence Int. 2017;48(9):743-751. doi: 10.3290/j.qi.a38855.
    Results Reference
    result

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    Postoperative Pain Following Restoration With Composite Resin Versus Sonic Fill

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