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Evaluation of Glass Ionomer With Advanced Glass Hybrid Technology Versus Resin Modified Glass Ionomer in Adult Patients With Carious Cervical Lesions After One Year

Primary Purpose

Dental Caries Class v

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Glass Ionomer with Advanced Glass Hybrid Technology (Equia forte HT fil, GC, Japan)
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries Class v

Eligibility Criteria

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

Inclusion Criteria: Patient inclusion: Patients aging ≥18 years. Patients with High caries risk. Patients with untreated cervical caries lesion that need restorative treatment. Males or females No abnormal occlusion for selected teeth. Patients with good likelihood of recall availability Tooth inclusion: Permanent teeth. Absence of mobility. Primary carious lesions. Vital with positive reaction to thermal stimulus . Exclusion Criteria: 1. Participants with general/systemic illness. 2. Concomitant participation in another research study. 3. Inability to comply with study procedures. 4. Heavy bruxism habits. 5. Last experience with allergic reactions against any components of the used materials. 6. Patients receiving orthodontic treatment. 7. Teeth supporting removable prosthesis 8. Patients with cervical caries lesions that need crown restoration. 9. Xerostomia. Tooth exclusion: Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure. Non-vital teeth. Periapcal Abscess or Fistula.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Glass Ionomer with Advanced Glass Hybrid Technology (Equia forte HT fil, GC, Japan)

    Resin Modified Glass Ionomer (Fugi II LC, GC, Japan).

    Arm Description

    Glass Hybrid restorative systems in the clinical point of view are self-cure bulk fill materials laminated with a nano-filled, self-adhesive resin coat. Nowadays, a new glass hybrid innovation called Advanced Glass Hybrid technology was achieved through introduction of ultra-fine highly reactive glass and high-molecular weight polyacrylic acid powders within conventional glass using prefractive indexes.

    Outcomes

    Primary Outcome Measures

    FDI criteria
    Esthetic and mechanical evaluation

    Secondary Outcome Measures

    Full Information

    First Posted
    November 8, 2022
    Last Updated
    November 8, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05617703
    Brief Title
    Evaluation of Glass Ionomer With Advanced Glass Hybrid Technology Versus Resin Modified Glass Ionomer in Adult Patients With Carious Cervical Lesions After One Year
    Official Title
    Evaluation of Glass Ionomer With Advanced Glass Hybrid Technology Versus Resin Modified Glass Ionomer in Adult Patients With Carious Cervical Lesions After One Year: Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2022 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    December 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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goal of this [type of study: Randomized clinical trial] to compare the clinical performance of using glass ionomer with advanced glass hybrid technology (AGH) in cervical carious lesion, versus Resin modified glass ionomer (RMGI) using esthetic and mechanical properties according to FDI criteria over one year. in adult patients with cervical carious lesion. The main question it aims to answer are: • Will the use of glass ionomer with advanced glass hybrid technology, achieved through introduction of ultra-fine highly reactive glass and high-molecular weight polyacrylic acid powders within conventional glass ,or Resin Modified Glass Ionomer have better mechanical and estheic properties over one year in adult patients with cervical carious lesions ? Participants will be assessed for medical and dental histories first. Then an examination of the patients will be done using visual inspection by using a dental mirror and probe. Eligible patients according to inclusion and exclusion criteria will be informed about all procedures with follow up time if they accept, their signature on written informed consents will be obtained. Eligible participants will be randomly divided into two groups according to the type of restoration that will be received after class V cavity preparations for carious cervical lesions. Patients will be given local anaesthesia (Mepecaine - L Cartridges) as required, and the teeth will be isolated. A No. #330 bur (MANI, INC, Japan) in a high-speed hand piece with air/water coolant will be used to prepare class V cavity. Sharp excavators of suitable size were used to excavate soft carious lesions in dentin. the prepared cavity will be isolated with rubber dam. The first group (A) will be received resin modified glass ionomer restorative material and the second group (B) will be received advanced glass hybrid glass ionomer . Each restoration will be evaluated for clinical parameters after finishing and polishing at baseline and regular recalls of 6 months and one year. The restorations will be clinically examined according to FDI criteria criteria in terms of esthetic and mechanical properties . The information that will be obtained will be collected and statistically analyzed.
    Detailed Description
    Eligibility criteria The participants were chosen according to the following eligibility criteria: Inclusion criteria Exclusion criteria Patient inclusion: Patients aging ≥18 years. Patients with High caries risk. Patients with untreated cervical caries lesion that need restorative treatment. Males or females No abnormal occlusion for selected teeth. Patients with good likelihood of recall availability Tooth inclusion: Permanent teeth. Absence of mobility. Primary carious lesions. Vital with positive reaction to thermal stimulus . Patient exclusion: Participants with general/systemic illness. Concomitant participation in another research study. Inability to comply with study procedures. Heavy bruxism habits. Last experience with allergic reactions against any components of the used materials. Patients receiving orthodontic treatment. Teeth supporting removable prosthesis Patients with cervical caries lesions that need crown restoration. Xerostomia. Tooth exclusion: Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure. Non-vital teeth. Periapical Abscess or Fistula. Outcomes: For each recall examination, two independent evaluators will perform the direct clinical evaluation at baseline, after 6 and 12 months using written criteria based on FDI criteria.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants will be randomly divided into two groups with a 1:1 allocation using computer generated randomization list (www.random.org).
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    This will be a double blinded study. The participants will not be informed to which group they will be assigned. The operator will be blinded because the restorative procedures for both groups are the same, the outcome assessors will not be informed about the type of restoration they evaluate.
    Allocation
    Randomized
    Enrollment
    22 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Glass Ionomer with Advanced Glass Hybrid Technology (Equia forte HT fil, GC, Japan)
    Arm Type
    Experimental
    Arm Description
    Glass Hybrid restorative systems in the clinical point of view are self-cure bulk fill materials laminated with a nano-filled, self-adhesive resin coat. Nowadays, a new glass hybrid innovation called Advanced Glass Hybrid technology was achieved through introduction of ultra-fine highly reactive glass and high-molecular weight polyacrylic acid powders within conventional glass using prefractive indexes.
    Arm Title
    Resin Modified Glass Ionomer (Fugi II LC, GC, Japan).
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Glass Ionomer with Advanced Glass Hybrid Technology (Equia forte HT fil, GC, Japan)
    Intervention Description
    Advanced Glass Hybrid technology (AGH) was achieved through introduction of ultra-fine highly reactive glass and high-molecular weight polyacrylic acid powders within conventional glass using particles and fillers with close refractive indexes
    Primary Outcome Measure Information:
    Title
    FDI criteria
    Description
    Esthetic and mechanical evaluation
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patient inclusion: Patients aging ≥18 years. Patients with High caries risk. Patients with untreated cervical caries lesion that need restorative treatment. Males or females No abnormal occlusion for selected teeth. Patients with good likelihood of recall availability Tooth inclusion: Permanent teeth. Absence of mobility. Primary carious lesions. Vital with positive reaction to thermal stimulus . Exclusion Criteria: 1. Participants with general/systemic illness. 2. Concomitant participation in another research study. 3. Inability to comply with study procedures. 4. Heavy bruxism habits. 5. Last experience with allergic reactions against any components of the used materials. 6. Patients receiving orthodontic treatment. 7. Teeth supporting removable prosthesis 8. Patients with cervical caries lesions that need crown restoration. 9. Xerostomia. Tooth exclusion: Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure. Non-vital teeth. Periapcal Abscess or Fistula.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    zayed
    Phone
    00201012561397
    Email
    aya_magdy@dentistry.cu.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    international and national publication

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    Evaluation of Glass Ionomer With Advanced Glass Hybrid Technology Versus Resin Modified Glass Ionomer in Adult Patients With Carious Cervical Lesions After One Year

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