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Desensitizing Effect and Tooth Color Change After Using Giomer-based Varnish Versus Bioactive Glass Air Polishing in Treating Cervical Hypersensitive Lesions

Primary Purpose

Dentin Hypersensitivity, Non-carious Cervical Lesions, Bioactive Glass Air Polishing, S-PRG

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Giomer varnish containing surface pre-reacted glass fillers
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Hypersensitivity, Non-carious Cervical Lesions, Bioactive Glass Air Polishing, S-PRG

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Participants complaining from dentin hypersensitivity. Middle aged patients. Good oral hygiene. Exclusion Criteria: Pregnant women. Patients with allergy to any material used in this study. Smoking patients will affect the oral hygiene and periodontal health. Patients taking anti-inflammatory drugs that will affect the perception of hypersensitivity. Systemically compromised patients. Smokers. Patients received desensitization treatment in the last 6 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Giomer varnish containing surface pre-reacted glass fillers

    Bioactive Glass Air Polishing

    Arm Description

    Giomer-based varnish is a light-curable varnish/desensitizer. The surface pre-reacted glass (S-PRG) filler is a bioactive trilaminar structure with a multifunctional glass core embedded in resin matrix. It can release and recharge fluoride ions. When it becomes in contact with the oral fluids, it starts to bind to the collagen fiber and release six different types of ions like fluoride, calcium, phosphate that help in the formation of apatite crystals and seal the open dentinal tubules with a long-lasting effect Brand name: S_PRG (Shofu-Japan)

    Bioactive glass powder delivered by standalone air polishing system, is a bioactive material that reacts with saliva to deposit Hydroxycarbonate Apatite crystals (HCA), which is very strong and resilient. The continuous release of calcium ions promotes constant protection and long lasting seal of the tubules. Using the air polishing delivery system helps to provide a huge amount of calcium and phosphate particles at the exposed surface of the tooth. Moreover, the air pressure aids in pushing these particles inside the dentinal tubules to a considerable depth. Air polishing using such powder provides a bifunctional advantage of occluding the dentinal tubules. However, there is limited clinical trials testing the efficacy of the bioactive glass powder air polishing system in minimizing the dentin hypersensitivity

    Outcomes

    Primary Outcome Measures

    Pain due to dentin hypersenstivity
    Dentin hypersensitivity was assessed by three different stimuli (evaporative , thermal and tactile) to simulate the different situations in which Dentin hypersensitivity arises. Using the Visual Analog scale (VAS), the participant marks the pain intensity on a graduated 10 cm straight line (0 = no pain, 10 = extreme pain)

    Secondary Outcome Measures

    Color change (Tooth discoloration)
    According to USPH criteria Alpha: Matches tooth Bravo: Acceptable mismatch Charlie: Unacceptable mismatch

    Full Information

    First Posted
    July 31, 2023
    Last Updated
    July 31, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05981625
    Brief Title
    Desensitizing Effect and Tooth Color Change After Using Giomer-based Varnish Versus Bioactive Glass Air Polishing in Treating Cervical Hypersensitive Lesions
    Official Title
    Desensitizing Effect and Tooth Color Change After Using Giomer-based Varnish Versus Bioactive Glass Air Polishing in Treating Cervical Hypersensitive Lesions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2024 (Anticipated)
    Primary Completion Date
    June 2025 (Anticipated)
    Study Completion Date
    March 2026 (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
    This trial is test the dentin hypersenstivity using Giomer based Varnish versus Bioactive glass air polishing system in patients with non-cervical lesions.
    Detailed Description
    To investigate the clinical effectiveness of Giomer based varnish versus Bioactive glass air polishing System in the management of dentin hypersensitivity and tooth color change in the cervical lesions. P:Patient/Population: Middle aged patients complaining of cervical dentin hypersensitivity. I: Giomer varnish containing surface pre-reacted glass fillers. C: Bio-active glass air polishing system: O:Dentin Hypersenstivity (Primary Outcome) was assessed by three different stimuli (evaporative , thermal and tactile) . O: Color Change (Secondary Outcome). T: Baseline, T1, T2, T3. S:a randomized clinical trial.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dentin Hypersensitivity, Non-carious Cervical Lesions, Bioactive Glass Air Polishing, S-PRG

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    34 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Giomer varnish containing surface pre-reacted glass fillers
    Arm Type
    Experimental
    Arm Description
    Giomer-based varnish is a light-curable varnish/desensitizer. The surface pre-reacted glass (S-PRG) filler is a bioactive trilaminar structure with a multifunctional glass core embedded in resin matrix. It can release and recharge fluoride ions. When it becomes in contact with the oral fluids, it starts to bind to the collagen fiber and release six different types of ions like fluoride, calcium, phosphate that help in the formation of apatite crystals and seal the open dentinal tubules with a long-lasting effect Brand name: S_PRG (Shofu-Japan)
    Arm Title
    Bioactive Glass Air Polishing
    Arm Type
    Active Comparator
    Arm Description
    Bioactive glass powder delivered by standalone air polishing system, is a bioactive material that reacts with saliva to deposit Hydroxycarbonate Apatite crystals (HCA), which is very strong and resilient. The continuous release of calcium ions promotes constant protection and long lasting seal of the tubules. Using the air polishing delivery system helps to provide a huge amount of calcium and phosphate particles at the exposed surface of the tooth. Moreover, the air pressure aids in pushing these particles inside the dentinal tubules to a considerable depth. Air polishing using such powder provides a bifunctional advantage of occluding the dentinal tubules. However, there is limited clinical trials testing the efficacy of the bioactive glass powder air polishing system in minimizing the dentin hypersensitivity
    Intervention Type
    Other
    Intervention Name(s)
    Giomer varnish containing surface pre-reacted glass fillers
    Intervention Description
    Giomer varnish (PRG barrier coat) will used as the intervention agent in this study. , Giomer is considered as a hybrid material between the resins modified glass ionomers and the composite resins. It is composed of 45% Sio2, 24.5% Na2O, 24.5% Ca O and 6% P2O5 . The presence of sodium is very important due to its bioactivity while the phosphate is responsible for the degree of degradation and formation of apatite. Based on this composition, giomer has several clinical applications in implant, periodontics, bone generation, pulp capping, Root canal treatment, as restorative materials, in air abrasion, enamel remineralization and finally dentin hypersensitivity
    Primary Outcome Measure Information:
    Title
    Pain due to dentin hypersenstivity
    Description
    Dentin hypersensitivity was assessed by three different stimuli (evaporative , thermal and tactile) to simulate the different situations in which Dentin hypersensitivity arises. Using the Visual Analog scale (VAS), the participant marks the pain intensity on a graduated 10 cm straight line (0 = no pain, 10 = extreme pain)
    Time Frame
    baseline preoperative, immediate postoperative, 1 , 6 and 12-months' time
    Secondary Outcome Measure Information:
    Title
    Color change (Tooth discoloration)
    Description
    According to USPH criteria Alpha: Matches tooth Bravo: Acceptable mismatch Charlie: Unacceptable mismatch
    Time Frame
    Baseline preoperative, immediate postoperative, 1,6 and 12-months time

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Participants complaining from dentin hypersensitivity. Middle aged patients. Good oral hygiene. Exclusion Criteria: Pregnant women. Patients with allergy to any material used in this study. Smoking patients will affect the oral hygiene and periodontal health. Patients taking anti-inflammatory drugs that will affect the perception of hypersensitivity. Systemically compromised patients. Smokers. Patients received desensitization treatment in the last 6 months
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    omnia Samy Garouda, master's
    Phone
    00201273573591
    Email
    omnia.mostafa@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Asmaa Yaseen, Professor
    Email
    Asmaa.yaseen@dentistry.cu.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29442087
    Citation
    Ravishankar P, Viswanath V, Archana D, Keerthi V, Dhanapal S, Lavanya Priya KP. The effect of three desensitizing agents on dentin hypersensitivity: A randomized, split-mouth clinical trial. Indian J Dent Res. 2018 Jan-Feb;29(1):51-55. doi: 10.4103/ijdr.IJDR_458_17.
    Results Reference
    background
    PubMed Identifier
    24993261
    Citation
    West N, Seong J, Davies M. Dentine hypersensitivity. Monogr Oral Sci. 2014;25:108-22. doi: 10.1159/000360749. Epub 2014 Jun 26.
    Results Reference
    background
    PubMed Identifier
    30639724
    Citation
    Favaro Zeola L, Soares PV, Cunha-Cruz J. Prevalence of dentin hypersensitivity: Systematic review and meta-analysis. J Dent. 2019 Feb;81:1-6. doi: 10.1016/j.jdent.2018.12.015. Epub 2019 Jan 11.
    Results Reference
    background
    PubMed Identifier
    25760065
    Citation
    Freitas Sda S, Sousa LL, Moita Neto JM, Mendes RF, Prado RR. Dentin hypersensitivity treatment of non-carious cervical lesions - a single-blind, split-mouth study. Braz Oral Res. 2015;29:45. doi: 10.1590/1807-3107BOR-2015.vol29.0045. Epub 2015 Mar 10.
    Results Reference
    background

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    Desensitizing Effect and Tooth Color Change After Using Giomer-based Varnish Versus Bioactive Glass Air Polishing in Treating Cervical Hypersensitive Lesions

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