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Evaluation of Ion Releasing Hybrid Restorative Material

Primary Purpose

Dental Caries

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Conventional resin composite
Activa Presto
Giomer
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

25 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patient-related criteria:

    • Patients consulting in one of the outpatient clinics listed above.
    • Patients can tolerate necessary restorative procedures.
    • Provide informed consent.
    • Patients accept the one year follow-up period.
    • Patients are within middle age group (25-40years).
    • Cooperative patients.
    • Patients don't have any medically compromised conditions.

Tooth related criteria:

  • Teeth with primary proximal carious lesions in posterior teeth with no pulpal involvement.
  • Teeth should have contact with the adjacent teeth.
  • Teeth are vital according to pulp-sensitivity tests.
  • No active gingival or periodontal conditions.

Exclusion Criteria:

  • • Medically compromised patients, as they will not be able to attend multiple appointments or may require special management.

    • Pregnant women; as radiographs are prohibited.
    • Allergic Patients to any of the restorative materials, including anesthetics.
    • Uncooperative patients will not follow the instructions or attend the appointments.

Tooth related criteria:

  • Retained deciduous teeth; as the research is targeting only permanent teeth.
  • Teeth with previous restorations, which may add another variable to the study (type of old restorative material, extent of recurrent caries).
  • Spontaneous pain or prolonged pain after sensitivity tests (cold and electrical tests) indicating irreversible pulpitis.
  • Negative sensitivity tests, periapical radiolucencies, and sensitivity to axial or lateral percussion indicating pulp necrosis.
  • Teeth presenting external or internal resorption, with adverse pulpal reactions which may affect the outcome of the study.
  • Teeth with cervical caries; which can't be evaluated on periapical radiographs.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Control

    Intervention 1

    Intervention 2

    Arm Description

    Conventional resin composite

    Activa Presto

    Giomer

    Outcomes

    Primary Outcome Measures

    Mechanical evaluation according to USPHS criteria
    Fracture, Retention, Marginal adaptation, Anatomic form, and Surface roughness

    Secondary Outcome Measures

    : Esthetic evaluation according to USPHS criteria. : Esthetic evaluation according to USPHS criteria. Esthetic evaluation according to USPHS criteria
    Color match, marginal discoloration, and restoration color stability

    Full Information

    First Posted
    April 20, 2021
    Last Updated
    September 8, 2021
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04854655
    Brief Title
    Evaluation of Ion Releasing Hybrid Restorative Material
    Official Title
    Evaluation of Calcium and Phosphate Releasing Hybrid Restorative Material and Fluoride Releasing Hybrid Restorative Material Versus the Conventional Resin Composite in Proximal Carious Lesions Over One Year Follow-up Using USPHS Criteria
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 10, 2021 (Anticipated)
    Primary Completion Date
    October 10, 2022 (Anticipated)
    Study Completion Date
    October 30, 2022 (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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Esthetic and mechanical evaluation of calcium and phosphate releasing hybrid restorative material and fluoride releasing hybrid restorative material versus the conventional nanofilled resin composite in proximal carious lesions over 1 year follow-up according to the USPHS criteria.
    Detailed Description
    3 groups of 45 patients will receive class II restorations by using calcium and phosphate releasing hybrid restorative material (Activa Presto), fluoride releasing hybrid restorative material (Giomer), and conventional nanofilled resin composite. Then these restorations evaluated at 24 hours after placement, 1 month, 3 months, 6 months and 12 months according the modified USPHS criteria in terms of fracture, marginal adaptation, retention, anatomic form, marginal discoloration, surface texture, and color match.

    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 ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Conventional resin composite
    Arm Title
    Intervention 1
    Arm Type
    Experimental
    Arm Description
    Activa Presto
    Arm Title
    Intervention 2
    Arm Type
    Experimental
    Arm Description
    Giomer
    Intervention Type
    Other
    Intervention Name(s)
    Conventional resin composite
    Intervention Description
    nanofilled resin composite
    Intervention Type
    Other
    Intervention Name(s)
    Activa Presto
    Intervention Description
    calcium and phosphate hybrid material
    Intervention Type
    Other
    Intervention Name(s)
    Giomer
    Intervention Description
    fluoride releasing hybrid material
    Primary Outcome Measure Information:
    Title
    Mechanical evaluation according to USPHS criteria
    Description
    Fracture, Retention, Marginal adaptation, Anatomic form, and Surface roughness
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    : Esthetic evaluation according to USPHS criteria. : Esthetic evaluation according to USPHS criteria. Esthetic evaluation according to USPHS criteria
    Description
    Color match, marginal discoloration, and restoration color stability
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patient-related criteria: Patients consulting in one of the outpatient clinics listed above. Patients can tolerate necessary restorative procedures. Provide informed consent. Patients accept the one year follow-up period. Patients are within middle age group (25-40years). Cooperative patients. Patients don't have any medically compromised conditions. Tooth related criteria: Teeth with primary proximal carious lesions in posterior teeth with no pulpal involvement. Teeth should have contact with the adjacent teeth. Teeth are vital according to pulp-sensitivity tests. No active gingival or periodontal conditions. Exclusion Criteria: • Medically compromised patients, as they will not be able to attend multiple appointments or may require special management. Pregnant women; as radiographs are prohibited. Allergic Patients to any of the restorative materials, including anesthetics. Uncooperative patients will not follow the instructions or attend the appointments. Tooth related criteria: Retained deciduous teeth; as the research is targeting only permanent teeth. Teeth with previous restorations, which may add another variable to the study (type of old restorative material, extent of recurrent caries). Spontaneous pain or prolonged pain after sensitivity tests (cold and electrical tests) indicating irreversible pulpitis. Negative sensitivity tests, periapical radiolucencies, and sensitivity to axial or lateral percussion indicating pulp necrosis. Teeth presenting external or internal resorption, with adverse pulpal reactions which may affect the outcome of the study. Teeth with cervical caries; which can't be evaluated on periapical radiographs.

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of Ion Releasing Hybrid Restorative Material

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