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Clinical Performance of Nanohybrid Resin Composite Lined With PRG Barrier Coat Compared to Resin Modified Glass Ionomer in Class V Carious Cavities Over 18 Months: Randomized Clinical Trial

Primary Purpose

Class V Dental Caries

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PRG barrier coat + nanohybrid composite
resin modified glass ionomer
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class V Dental Caries focused on measuring PRG barrier coat, nanohybrid resin composite, Resin modified glass ionomer

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 18-60 years Males or females. Patients with untreated cervical carious lesion that need restoration. Participants available for recall Patients with moderate to high caries risk Teeth Inclusion Criteria No spontaneous pain Absence of tooth mobility Exclusion Criteria: Patients with para-functional habits Experience with allergic reactions against any component of used materials. Teeth Exclusion Criteria Non-vital teeth Teeth with orthodontic appliance Teeth with advanced periodontal diseases.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    PRG barrier coat

    Resin modified glass ionomer

    Arm Description

    It is a light cured surface-partially reacted glass (S-PRG) filler particles with a multifunctional glass core embedded in a resin matrix.

    Resin modified glass ionomer (Fuji II LC, GC, Japan). RMGIC are glass-ionomer cements with small quantity of monomers and initiators so the acid-base reaction is supplemented by a second polymerization reaction.

    Outcomes

    Primary Outcome Measures

    Modified USPHS criteria
    Retention, marginal discoloration, marginal adaptation, secondary caries

    Secondary Outcome Measures

    Modified USPHS criteria
    Postoperative hypersensitivity

    Full Information

    First Posted
    October 29, 2022
    Last Updated
    October 29, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05605457
    Brief Title
    Clinical Performance of Nanohybrid Resin Composite Lined With PRG Barrier Coat Compared to Resin Modified Glass Ionomer in Class V Carious Cavities Over 18 Months: Randomized Clinical Trial
    Official Title
    Clinical Performance of Nanohybrid Resin Composite Lined With PRG Barrier Coat Compared to Resin Modified Glass Ionomer in Class V Carious Cavities Over 18 Months: Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2023 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    August 2024 (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
    Yes

    5. Study Description

    Brief Summary
    Class V carious lesions will be restored using two different restorative materials either Resin modified glass ionomer or nanohybrid resin composite lined by PRG barrier coat. Each restoration will be evaluated for clinical parameters after finishing and polishing at baseline, at 6 months, 12 months and at 18 months. The restorations will be clinically examined according to modified USPHS criteria in terms of retention, marginal adaptation, marginal discoloration, secondary caries and postoperative sensitivity.
    Detailed Description
    Class V carious lesions will be restored using two different restorative materials either resin modified glass ionomer or nanohybrid resin composite lined by PRG barrier coat.Each restoration will be evaluated for clinical parameters after finishing and polishing at baseline, at 3 months, 6 months, 12 months and at 18 months. The restorations will be clinically examined according to modified USPHS criteria in terms of retention, marginal adaptation, marginal discoloration, secondary caries and postoperative sensitivity.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Class V Dental Caries
    Keywords
    PRG barrier coat, nanohybrid resin composite, Resin modified glass ionomer

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    PRG barrier coat
    Arm Type
    Experimental
    Arm Description
    It is a light cured surface-partially reacted glass (S-PRG) filler particles with a multifunctional glass core embedded in a resin matrix.
    Arm Title
    Resin modified glass ionomer
    Arm Type
    Active Comparator
    Arm Description
    Resin modified glass ionomer (Fuji II LC, GC, Japan). RMGIC are glass-ionomer cements with small quantity of monomers and initiators so the acid-base reaction is supplemented by a second polymerization reaction.
    Intervention Type
    Device
    Intervention Name(s)
    PRG barrier coat + nanohybrid composite
    Intervention Description
    It is a light cured surface-partially reacted glass (S-PRG) filler particles with a multifunctional glass core embedded in a resin matrix.
    Intervention Type
    Device
    Intervention Name(s)
    resin modified glass ionomer
    Intervention Description
    RMGIC are glass-ionomer cements with small quantity of monomers and initiators so the acid-base reaction is supplemented by a second polymerization reaction
    Primary Outcome Measure Information:
    Title
    Modified USPHS criteria
    Description
    Retention, marginal discoloration, marginal adaptation, secondary caries
    Time Frame
    18 months
    Secondary Outcome Measure Information:
    Title
    Modified USPHS criteria
    Description
    Postoperative hypersensitivity
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 18-60 years Males or females. Patients with untreated cervical carious lesion that need restoration. Participants available for recall Patients with moderate to high caries risk Teeth Inclusion Criteria No spontaneous pain Absence of tooth mobility Exclusion Criteria: Patients with para-functional habits Experience with allergic reactions against any component of used materials. Teeth Exclusion Criteria Non-vital teeth Teeth with orthodontic appliance Teeth with advanced periodontal diseases.

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Performance of Nanohybrid Resin Composite Lined With PRG Barrier Coat Compared to Resin Modified Glass Ionomer in Class V Carious Cavities Over 18 Months: Randomized Clinical Trial

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