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Assessment of Bioactive Bulk Fill Composite Versus High Viscosity Glass Ionomer Restorations for Carious Lesions

Primary Purpose

Secondary Dental Caries

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Predicta Bioactive bulk fil composite restoration
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Secondary Dental Caries

Eligibility Criteria

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

Inclusion Criteria:

Patient inclusion:

  1. Patients Scheduled for head and neck radiotherapy.
  2. age: ≥18 years.
  3. Patients with good likelihood of recall availability.

Tooth inclusion:

  1. Permanent premolars or molars.
  2. Primary occlusal carious lesions.
  3. Vital with positive reaction to cold thermal stimulus.
  4. Well-formed and fully-erupted.

Exclusion Criteria:Patient exclusion:

  1. Participants with late stage head and neck cancer
  2. Concomitant participation in another research study.
  3. Inability to comply with study procedures
  4. past experience with allergic reactions against any components of the used materials Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.

N 2-Non-vital teeth. 3-Secondary carious lesions

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Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Predicta Bioactive bulk fil composite restoration

    High viscosity glass ionomer (Equia Fil)

    Arm Description

    Bioactive bulk fil resin composite dental restoration material

    High viscosity dental restoration material

    Outcomes

    Primary Outcome Measures

    Secondary caries
    biological outcome

    Secondary Outcome Measures

    Full Information

    First Posted
    April 6, 2022
    Last Updated
    April 14, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05332041
    Brief Title
    Assessment of Bioactive Bulk Fill Composite Versus High Viscosity Glass Ionomer Restorations for Carious Lesions
    Official Title
    Clinical Assessment of Bioactive Bulk Fill Composite Versus High Viscosity Glass Ionomer Restorations for Restoring Occlusal Carious Lesions of Posterior Teeth in Patients Scheduled for Head and Neck Radiotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2022 (Anticipated)
    Primary Completion Date
    July 1, 2023 (Anticipated)
    Study Completion Date
    September 1, 2023 (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 trial will be conducted to compare the clinical performance between a new bioactive resin composite material and high viscosity glass ionomer for restoring occlusal carious lesions of posterior teeth in patients scheduled for head and neck radiotherapy.
    Detailed Description
    Inspite of recent developments in the materials' science, some novel materials require direct association with components of the oral cavity for renewal or recharging of the constituents of the restoration to enhance marginal integrity and thus decrease bacterial microleakage, marginal discoloration and postoperative hypersensitivity . There is a constant increase in aesthetic demand for a material that ensures near to perfect adhesion to the tooth surface in order to minimize microleakage and improve marginal integrity. Microleakage forms the basis for predicting the performance of any restorative material Bioactive restorative materials have been introduced for numerous utilizations in dentistry. Among these are fluorides for remineralization; antibacterial resins and restoratives that release and recharge fluorides, phosphate and hydroxyle ions and thus can enhance marginal integrity . Bioactive restorative materials are reported to release more fluoride than glass ionomers. Additionally, they react to pH changes in the mouth by uptaking calcium, phosphate, and fluoride ions to maintain the chemical integrity of the tooth structure. It is proposed that contemporary bioactive esthetic materials, which associate with oral fluids and show recharge and renewal of restorative material constituents, have the potential to reduce bacterial microleakage and enhance marginal integrity, One possible approach to increase the resistance of restorations to secondary caries formation is to use bioactive materials ( Like predicta bilk fil composite) that contain agents which negatively influence the micro-organisms and/or promote remineralization of tooth structure. High viscosity glass ionomer (EQUIA Fil) has new technology that contains ultrafine and highly reactive glass diffused within the glass-ionomer fillers to increase and enhance matrix formation. This system allows ion availability and builds a stronger matrix structure with greater physical properties, wear resistance and fluoride release.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    28 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Predicta Bioactive bulk fil composite restoration
    Arm Type
    Experimental
    Arm Description
    Bioactive bulk fil resin composite dental restoration material
    Arm Title
    High viscosity glass ionomer (Equia Fil)
    Arm Type
    Active Comparator
    Arm Description
    High viscosity dental restoration material
    Intervention Type
    Other
    Intervention Name(s)
    Predicta Bioactive bulk fil composite restoration
    Intervention Description
    Predicta Bioactive bulk fil resin composite restoration material
    Primary Outcome Measure Information:
    Title
    Secondary caries
    Description
    biological outcome
    Time Frame
    one year follow up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patient inclusion: Patients Scheduled for head and neck radiotherapy. age: ≥18 years. Patients with good likelihood of recall availability. Tooth inclusion: Permanent premolars or molars. Primary occlusal carious lesions. Vital with positive reaction to cold thermal stimulus. Well-formed and fully-erupted. Exclusion Criteria:Patient exclusion: Participants with late stage head and neck cancer Concomitant participation in another research study. Inability to comply with study procedures past experience with allergic reactions against any components of the used materials Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure. N 2-Non-vital teeth. 3-Secondary carious lesions -

    12. IPD Sharing Statement

    Learn more about this trial

    Assessment of Bioactive Bulk Fill Composite Versus High Viscosity Glass Ionomer Restorations for Carious Lesions

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