xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05981625</url>
    </required_header>
    <id_info>
      <org_study_id>14422022559057</org_study_id>
      <nct_id>NCT05981625</nct_id>
    </id_info>
    <brief_title>Desensitizing Effect and Tooth Color Change After Using Giomer-based Varnish Versus Bioactive Glass Air Polishing in Treating Cervical Hypersensitive Lesions</brief_title>
    <official_title>Desensitizing Effect and Tooth Color Change After Using Giomer-based Varnish Versus Bioactive Glass Air Polishing in Treating Cervical Hypersensitive Lesions</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This trial is test the dentin hypersenstivity using Giomer based Varnish versus Bioactive&#xD;
        glass air polishing system in patients with non-cervical lesions.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        To investigate the clinical effectiveness of Giomer based varnish versus Bioactive glass air&#xD;
        polishing System in the management of dentin hypersensitivity and tooth color change in the&#xD;
        cervical lesions.&#xD;
  &#xD;
        P:Patient/Population: Middle aged patients complaining of cervical dentin hypersensitivity.&#xD;
        I: Giomer varnish containing surface pre-reacted glass fillers. C: Bio-active glass air&#xD;
        polishing system: O:Dentin Hypersenstivity (Primary Outcome) was assessed by three different&#xD;
        stimuli (evaporative , thermal and tactile) . O: Color Change (Secondary Outcome). T:&#xD;
        Baseline, T1, T2, T3. S:a randomized clinical trial.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">April 2024</start_date>
    <completion_date type="Anticipated">March 2026</completion_date>
    <primary_completion_date type="Anticipated">June 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pain due to dentin hypersenstivity</measure>
      <time_frame>baseline preoperative, immediate postoperative, 1 , 6 and 12-months' time</time_frame>
      <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&#xD;
  = no pain, 10 = extreme pain)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Color change (Tooth discoloration)</measure>
      <time_frame>Baseline preoperative, immediate postoperative, 1,6 and 12-months time</time_frame>
      <description>According to USPH criteria Alpha: Matches tooth Bravo: Acceptable mismatch Charlie: Unacceptable mismatch</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">34</enrollment>
    <condition>Dentin Hypersensitivity, Non-carious Cervical Lesions, Bioactive Glass Air Polishing, S-PRG</condition>
    <arm_group>
      <arm_group_label>Giomer varnish containing surface pre-reacted glass fillers</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Bioactive Glass Air Polishing</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <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</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Giomer varnish containing surface pre-reacted glass fillers</intervention_name>
      <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&#xD;
  . 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</description>
      <arm_group_label>Bioactive Glass Air Polishing</arm_group_label>
      <arm_group_label>Giomer varnish containing surface pre-reacted glass fillers</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants complaining from dentin hypersensitivity.&#xD;
  &#xD;
            -  Middle aged patients.&#xD;
  &#xD;
            -  Good oral hygiene.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant women.&#xD;
  &#xD;
            -  Patients with allergy to any material used in this study.&#xD;
  &#xD;
            -  Smoking patients will affect the oral hygiene and periodontal health.&#xD;
  &#xD;
            -  Patients taking anti-inflammatory drugs that will affect the perception of&#xD;
               hypersensitivity.&#xD;
  &#xD;
            -  Systemically compromised patients.&#xD;
  &#xD;
            -  Smokers.&#xD;
  &#xD;
            -  Patients received desensitization treatment in the last 6 months&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>30 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>omnia Samy Garouda, master's</last_name>
      <phone>00201273573591</phone>
      <email>omnia.mostafa@dentistry.cu.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Asmaa Yaseen, Professor</last_name>
      <email>Asmaa.yaseen@dentistry.cu.edu.eg</email>
    </overall_contact_backup>
    <reference>
      <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.</citation>
      <PMID>29442087</PMID>
    </reference>
    <reference>
      <citation>West N, Seong J, Davies M. Dentine hypersensitivity. Monogr Oral Sci. 2014;25:108-22. doi: 10.1159/000360749. Epub 2014 Jun 26.</citation>
      <PMID>24993261</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>30639724</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>25760065</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>omnia samy Garouda</investigator_full_name>
      <investigator_title>Assistant Lecturer</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dentin Sensitivity</mesh_term>
      <mesh_term>Hypersensitivity</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05981625
  org study id: 14422022559057
  nct id: NCT05981625
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This trial is test the dentin hypersenstivity using Giomer based Varnish versus Bioactive
        glass air polishing system in patients with non-cervical lesions.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Outcomes Assessor)
  measure: Pain due to dentin hypersenstivity
  time frame: baseline preoperative, immediate postoperative, 1 , 6 and 12-months' time
  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)
  measure: Color change (Tooth discoloration)
  time frame: Baseline preoperative, immediate postoperative, 1,6 and 12-months time
  description: According to USPH criteria Alpha: Matches tooth Bravo: Acceptable mismatch Charlie: Unacceptable mismatch
  arm group label: Giomer varnish containing surface pre-reacted glass fillers
  arm group type: Experimental
  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 group label: Bioactive Glass Air Polishing
  arm group type: Active Comparator
  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: Giomer varnish containing surface pre-reacted glass fillers
  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
  arm group label: Bioactive Glass Air Polishing
  arm group label: Giomer varnish containing surface pre-reacted glass fillers
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 30 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: omnia Samy Garouda, master's
  phone: 00201273573591
  email: omnia.mostafa@dentistry.cu.edu.eg
  last name: Asmaa Yaseen, Professor
  email: Asmaa.yaseen@dentistry.cu.edu.eg
  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.
  PMID: 29442087
  citation: West N, Seong J, Davies M. Dentine hypersensitivity. Monogr Oral Sci. 2014;25:108-22. doi: 10.1159/000360749. Epub 2014 Jun 26.
  PMID: 24993261
  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.
  PMID: 30639724
  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.
  PMID: 25760065
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: omnia samy Garouda
  investigator title: Assistant Lecturer
  mesh term: Dentin Sensitivity
  mesh term: Hypersensitivity
  sharing ipd: No