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Evaluation Of Clinical Performance of Self-adhering Flowable Composite vs Conventional Flowable Composite in Cervical Carious Lesions

Primary Purpose

Dental Caries

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Self-Adhesive Flowable Composite
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Cervical Class V carious lesions in anterior and premolars teeth.
  • Age above 60 years.
  • Males and females.

Exclusion Criteria:

  • • patient less than 60 years with disabilities, systemic disease, severe medical conditions, rampant caries, and xerostomia.

    • In addition, teeth with potential prosthodontics restoration and nonvital or endodontically treated teeth.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Fusio™ Flowable Self-Adhesive Flowable Composite

    Conventional flowable composite [Tetric Evo Flow (FF)].

    Arm Description

    2-Cavity preparation steps: patients will be given local anesthesia as required,the operative field will be isolated with rubber dam before starting. Conventional design Class V cavity will be prepared on the buccal surface of tooth by No. #330 bur (0.8 mm in diameter and 1.6 mm in length) , tooth surfaces will be kept moist to protect them against dehydration. 2% chlorhexidine gluconate disinfecting solution . wash the dentin surface with water spray and air dry with maximum air pressure for 5 s. A) Intervention: Fusio™ Flowable (Self adhesive flowable composite): Simply syringe into the preparation 1 mm increments, agitate with tip or brush for 20 s, and light-cure.No need for an etchant or an adhesive.

    Tetric Evo Flow (Conventional flowable composite): After cleaning cavities, apply conditioning material (phosphoric acid etching 37% ) and apply bonding agent (ExciTE® F) according to the instructions for use of the product. Apply Tetric EvoFlow in layers of 1mm. Polymerize each layer separately following the instructions for use of this product. . Hold the light emission window as closely as possible to the surface of the restorative material. All 20 Class V restorations will be prepared, restored, finished, and polished by one operator. Each of the 10 patients had one (FL) restoration and the other restoration will be filled with (FF).

    Outcomes

    Primary Outcome Measures

    Marginal integrity of Class V restorations
    clinical evaluation according to Modified USPHS Criteria (Bayne and Schmalz, 2005) unit of measurement :Alfa, Bravo,charlie and Delta

    Secondary Outcome Measures

    Postoperative sensitivity
    clinical evaluation according to Modified United States Public Health Service Criteria (Bayne and Schmalz, 2005)

    Full Information

    First Posted
    July 10, 2020
    Last Updated
    July 16, 2020
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04475172
    Brief Title
    Evaluation Of Clinical Performance of Self-adhering Flowable Composite vs Conventional Flowable Composite in Cervical Carious Lesions
    Official Title
    Evaluation Of Clinical Performance of Self-adhering Flowable Composite vs Conventional Flowable Composite in Cervical Carious Lesions: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2020 (Anticipated)
    Primary Completion Date
    September 2021 (Anticipated)
    Study Completion Date
    October 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
    This clinical trial will be conducted to compare the clinical performance of a new self-adhering flowable composite in restoring CLs compared to conventional flowable composite in geriatric patients over 12 months.
    Detailed Description
    Recently, self-adhesive flowable composites (SAFCs) have been introduced as a new class of restorative material in adhesive dentistry. Today, there are only two available products in the market for clinical use: Vertise Flow and Fusio Liquid Dentin. Self-adhering flowable composite was introduced to address the time-consuming procedure used with traditional materials Their resin matrix contains acidic functional adhesive monomers mediating bonding with dental hard tissues and, therefore, separate etching and additional bonding are not required. SAFCs have been mainly advertised for the restoration of small Class I, Class III and V cavities, for cavity lining, and for use as a pit and fissure sealant. Self-adhering flowable composite combines the merits of both adhesive and restorative material technologies in one product, bringing novel horizons to restorative techniques, as it is a direct composite resin restorative material that has an adhesive resin together with a flowable composite resin. It is based on the bonding technology that uses glycerophosphate dimethacrylate(GPDM)to etch enamel and dentin, and hydroxyethyl methacrylate (HEMA) to enhance wetting and penetration by resin into dentin. This resin bonds chemically between the phosphate groups of a GPDM monomer and the hydroxyapatite of tooth structure and, also, micromechanically between the polymerized monomers of the self-adhering flowable composite resin and the collagen fibers and smear layer of dentin.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Caries

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Quadruple
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Fusio™ Flowable Self-Adhesive Flowable Composite
    Arm Type
    Experimental
    Arm Description
    2-Cavity preparation steps: patients will be given local anesthesia as required,the operative field will be isolated with rubber dam before starting. Conventional design Class V cavity will be prepared on the buccal surface of tooth by No. #330 bur (0.8 mm in diameter and 1.6 mm in length) , tooth surfaces will be kept moist to protect them against dehydration. 2% chlorhexidine gluconate disinfecting solution . wash the dentin surface with water spray and air dry with maximum air pressure for 5 s. A) Intervention: Fusio™ Flowable (Self adhesive flowable composite): Simply syringe into the preparation 1 mm increments, agitate with tip or brush for 20 s, and light-cure.No need for an etchant or an adhesive.
    Arm Title
    Conventional flowable composite [Tetric Evo Flow (FF)].
    Arm Type
    Active Comparator
    Arm Description
    Tetric Evo Flow (Conventional flowable composite): After cleaning cavities, apply conditioning material (phosphoric acid etching 37% ) and apply bonding agent (ExciTE® F) according to the instructions for use of the product. Apply Tetric EvoFlow in layers of 1mm. Polymerize each layer separately following the instructions for use of this product. . Hold the light emission window as closely as possible to the surface of the restorative material. All 20 Class V restorations will be prepared, restored, finished, and polished by one operator. Each of the 10 patients had one (FL) restoration and the other restoration will be filled with (FF).
    Intervention Type
    Combination Product
    Intervention Name(s)
    Self-Adhesive Flowable Composite
    Other Intervention Name(s)
    Fusio™ Flowable Self-Adhesive Flowable Composite
    Intervention Description
    Fusio Self-Adhesive Flowable Composite combines the benefits of adhesive and restorative technology into one product . Immediately upon application Fusio conditions, bonds, and seals without the need for an etchant or an adhesive. It is based on the bonding technology that uses glycerophosphate dimethacrylate(GPDM)to etch enamel and dentin, and hydroxyethyl methacrylate (HEMA) to enhance wetting and penetration by resin into dentin.
    Primary Outcome Measure Information:
    Title
    Marginal integrity of Class V restorations
    Description
    clinical evaluation according to Modified USPHS Criteria (Bayne and Schmalz, 2005) unit of measurement :Alfa, Bravo,charlie and Delta
    Time Frame
    Clinical Evaluation of Marginal integrity after 6 months after starting treatment.
    Secondary Outcome Measure Information:
    Title
    Postoperative sensitivity
    Description
    clinical evaluation according to Modified United States Public Health Service Criteria (Bayne and Schmalz, 2005)
    Time Frame
    at baseline and 3 months after starting treatment .

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Cervical Class V carious lesions in anterior and premolars teeth. Age above 60 years. Males and females. Exclusion Criteria: • patient less than 60 years with disabilities, systemic disease, severe medical conditions, rampant caries, and xerostomia. In addition, teeth with potential prosthodontics restoration and nonvital or endodontically treated teeth.

    12. IPD Sharing Statement

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