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Clinical Assessment of Giomer Based Technology Versus Smart Bioactive Restoration in Carious Class V Cavities

Primary Purpose

Dental Caries

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Beautifil Flow Plus X.
Activa bioactive restorative
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

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • ages 18 to 55 years.
  • Male or female patients.
  • Patients with no history of allergic reactions to methacrylate compounds and in good general health.
  • Patients with good general health.
  • Patients with good recall availability. Patients required Class V restoration
  • Vital teeth with normal appearance and morphology.
  • Absence of clinical symptoms of irreversible pulpitis, such as spontaneous pain or sensitivity to pressure.
  • Absence of clinical diagnosis of pulp exposure, fistula, swelling of periodontal tissues, and/or abnormal tooth mobility .
  • No defects and lesions for other operative intervention, occlusal and proximal contacts with adjacent teeth.

Exclusion Criteria:

  • Patients with history of any adverse reaction to clinical materials of the types to be used in the evaluation.

    • Pregnant and lactating females.
    • Any patients with medical and/or dental histories which could possibly complicate the provision of the proposed restoration and/or influence behavior and performance of the restorations in clinical service.
    • They are included in the evaluation of other restorative materials and systems involving the anterior and/or posterior teeth.
    • Patients who maintain an unacceptable standard of oral hygiene.
    • Teeth with noncarious cervical lesions.
    • Severe tooth sensitivity.
    • Non-vital or fracture or cracked teeth.
    • Tooth with defective restoration.
    • Teeth with advanced periodontal diseases.
    • There is evidence occlusal parafunctions and/or atypical tooth wear.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Beautifil Flow Plus X.

    Activa bioactive restorative

    Arm Description

    Giomers is a hybrid material category which contains Surface Pre-Reacted Glass-ionomer filler or S-PRG filler is produced from fluoroboro-alumino-silicate glass and polyacrylic acid through an acid-base reaction to form a stable glass ionomer phase on glass filler particle surfaces. S-PRG fillers can release and recharge fluoride. Also, the S-PRG filler-containing resinous materials are able to release various ions, such as aluminum (Al3+), boron (BO3 3-), fluoride (F- ), sodium (Na+), silicon (SiO3 2-), and strontium (Sr2+), in neutral and acidic conditions.

    Activa BioACTIVE Restorative (Activa), developed by Pulpdent (Watertown, MA, USA), is a new bioactive restorative material that combines the advantages of an RMGIC (resin modified glass ionomer cement) and RBC (resin based composite), representing a new category of restorative materials that are ion releasing. It contains methacrylate- based monomers, a modified polyacrylic acid, modified Diurethane Dimethacrylate (rubberized resin), and fillers

    Outcomes

    Primary Outcome Measures

    Assessment of Modified USPHS Criteria (Marginal discoloration) change over time
    Alfa: there is no visual evidence of marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure. Bravo: there is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration that has not penetrated along the restoration in a pulpal direction. Charlie: there is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration, but the discoloration has penetrated along the restoration in a pulpal direction.

    Secondary Outcome Measures

    Assessment of Modified USPHS criteria. (Secondary caries) change over time
    Alfa: no caries is present. Charlie: caries is present.

    Full Information

    First Posted
    July 15, 2022
    Last Updated
    September 20, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05466461
    Brief Title
    Clinical Assessment of Giomer Based Technology Versus Smart Bioactive Restoration in Carious Class V Cavities
    Official Title
    Clinical Assessment of Injectable Flowable Composite With Giomer Based Technology Versus Smart Bioactive Restoration in Carious Class V Cavities (A Randomized Clinical Trial)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2022 (Anticipated)
    Primary Completion Date
    November 1, 2023 (Anticipated)
    Study Completion Date
    January 1, 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
    No

    5. Study Description

    Brief Summary
    This study will compare between S-PRG-containing injectable flowable resin composite (Beautifil Flow Plus X) and smart bioactive flowable resin composite (Activa bioactive restorative) through evaluation of the modified USPHS clinical performance in patients with carious class V moderately deep cavities.
    Detailed Description
    Bioactive glass has an amorphous structure, whereas glass-ceramics are crystallized glasses and composites of a crystalline phase in a residual glassy phase. Bioactive glass consists solely of the elements found in the body material, mainly being silicon (Si), calcium (Ca), sodium (Na), phosphorous (P), and oxygen (O) . Among the diverse kinds of bioactive glass filler, surface pre- reacted glass ionomer (S-PRG) filler has already been used for a relatively long time in some specific commercial RBCs. Most studies investigating this material assortment have focused on ion-release degree and potentially associated antibacterial effects. The restoration's surface integrity may be a key factor determining the eventual clinical beneficial effect of the alleged antibacterial properties. The antibacterial efficacy of bioactive glass depends on the concentration of the ions released from the glass. As inorganic bioactive fillers, S-PRGs have the additional ability to release ions. S-PRG filler is considered a multifunctional bioactive glass because it can release several types of ions including Al, B, F, Na, Si, and Sr. The released ions can exhibit a variety of bioactive behaviors, such as preventing fungal and bacterial adhesion, antibacterial activity, neutralizing acids, inhibiting demineralization, and enhancing remineralization. The biological effects of S-PRG fillers have been studied for several types of oral pathogens. It was reported that the elute of the S-PRG filler has a protective effect against Streptococcus mutans. Moreover, the elute of S-PRG filler reduced the density and thickness of the formed biofilm.

    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
    Model Description
    Compare between S-PRG-containing injectable flowable resin composite (Beautifil Flow Plus X) and smart bioactive flowable resin composite (Activa bioactive restorative) over one year through evaluation of the modified USPHS clinical performance in patients with carious class V moderately deep cavities.
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    During treatment, the type of material will be concealed from the patient, and the patient will have no information which material will be used. The type of restoration will not mentioned in the patient's file. Instead, it will be replaced by a combination which the evaluators will be not familiar with. The operator will be blinded for the type of restoration during tooth preparation and was informed only at the time of restoration placement. The purpose of this discretion is to ensure double blinding both at the patient, as well as the evaluators level.
    Allocation
    Randomized
    Enrollment
    34 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Beautifil Flow Plus X.
    Arm Type
    Experimental
    Arm Description
    Giomers is a hybrid material category which contains Surface Pre-Reacted Glass-ionomer filler or S-PRG filler is produced from fluoroboro-alumino-silicate glass and polyacrylic acid through an acid-base reaction to form a stable glass ionomer phase on glass filler particle surfaces. S-PRG fillers can release and recharge fluoride. Also, the S-PRG filler-containing resinous materials are able to release various ions, such as aluminum (Al3+), boron (BO3 3-), fluoride (F- ), sodium (Na+), silicon (SiO3 2-), and strontium (Sr2+), in neutral and acidic conditions.
    Arm Title
    Activa bioactive restorative
    Arm Type
    Active Comparator
    Arm Description
    Activa BioACTIVE Restorative (Activa), developed by Pulpdent (Watertown, MA, USA), is a new bioactive restorative material that combines the advantages of an RMGIC (resin modified glass ionomer cement) and RBC (resin based composite), representing a new category of restorative materials that are ion releasing. It contains methacrylate- based monomers, a modified polyacrylic acid, modified Diurethane Dimethacrylate (rubberized resin), and fillers
    Intervention Type
    Procedure
    Intervention Name(s)
    Beautifil Flow Plus X.
    Intervention Description
    Class V cavities will be prepared, Selective etching technique will be used with phosphoric acid etching gel for 15 seconds on enamel.Single Bond TM Universal will be applied to cavity walls and margins with agitation for 20 seconds.The adhesive will be light-cured for 20 seconds. Then Beautifil Flow Plus X composite will be placed
    Intervention Type
    Procedure
    Intervention Name(s)
    Activa bioactive restorative
    Intervention Description
    Class V cavities will be prepared, Selective etching technique will be used with phosphoric acid etching gel for 15 seconds on enamel. Bonding agent will be applied on the entire cavity and light-cured for 20 seconds then Activa bioactive restorative composite will be applied and cured for 20 seconds.
    Primary Outcome Measure Information:
    Title
    Assessment of Modified USPHS Criteria (Marginal discoloration) change over time
    Description
    Alfa: there is no visual evidence of marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure. Bravo: there is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration that has not penetrated along the restoration in a pulpal direction. Charlie: there is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration, but the discoloration has penetrated along the restoration in a pulpal direction.
    Time Frame
    Change between baseline,6 months and 12 months
    Secondary Outcome Measure Information:
    Title
    Assessment of Modified USPHS criteria. (Secondary caries) change over time
    Description
    Alfa: no caries is present. Charlie: caries is present.
    Time Frame
    Change between baseline,6 months and 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: ages 18 to 55 years. Male or female patients. Patients with no history of allergic reactions to methacrylate compounds and in good general health. Patients with good general health. Patients with good recall availability. Patients required Class V restoration Vital teeth with normal appearance and morphology. Absence of clinical symptoms of irreversible pulpitis, such as spontaneous pain or sensitivity to pressure. Absence of clinical diagnosis of pulp exposure, fistula, swelling of periodontal tissues, and/or abnormal tooth mobility . No defects and lesions for other operative intervention, occlusal and proximal contacts with adjacent teeth. Exclusion Criteria: Patients with history of any adverse reaction to clinical materials of the types to be used in the evaluation. Pregnant and lactating females. Any patients with medical and/or dental histories which could possibly complicate the provision of the proposed restoration and/or influence behavior and performance of the restorations in clinical service. They are included in the evaluation of other restorative materials and systems involving the anterior and/or posterior teeth. Patients who maintain an unacceptable standard of oral hygiene. Teeth with noncarious cervical lesions. Severe tooth sensitivity. Non-vital or fracture or cracked teeth. Tooth with defective restoration. Teeth with advanced periodontal diseases. There is evidence occlusal parafunctions and/or atypical tooth wear.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bassma Reda AbdelHafeez, Assistant Lecturer
    Phone
    00201092182646
    Email
    Basma.reda@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mai Mamdouh, Associate Professor
    Email
    Mai.Mamdouh@dentistry.cu.edu.eg

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28465066
    Citation
    Yoshihara K, Nagaoka N, Maruo Y, Sano H, Yoshida Y, Van Meerbeek B. Bacterial adhesion not inhibited by ion-releasing bioactive glass filler. Dent Mater. 2017 Jun;33(6):723-734. doi: 10.1016/j.dental.2017.04.002. Epub 2017 Apr 29.
    Results Reference
    background
    PubMed Identifier
    29568011
    Citation
    Nomura R, Morita Y, Matayoshi S, Nakano K. Inhibitory effect of surface pre-reacted glass-ionomer (S-PRG) eluate against adhesion and colonization by Streptococcus mutans. Sci Rep. 2018 Mar 22;8(1):5056. doi: 10.1038/s41598-018-23354-x.
    Results Reference
    background
    PubMed Identifier
    34772173
    Citation
    Tonprasong W, Inokoshi M, Tamura M, Uo M, Wada T, Takahashi R, Hatano K, Shimizubata M, Minakuchi S. Tissue Conditioner Incorporating a Nano-Sized Surface Pre-Reacted Glass-Ionomer (S-PRG) Filler. Materials (Basel). 2021 Nov 4;14(21):6648. doi: 10.3390/ma14216648.
    Results Reference
    background

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    Clinical Assessment of Giomer Based Technology Versus Smart Bioactive Restoration in Carious Class V Cavities

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