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/NCT06003452</url>
    </required_header>
    <id_info>
      <org_study_id>Fissure sealnt</org_study_id>
      <nct_id>NCT06003452</nct_id>
    </id_info>
    <brief_title>Retention Rate And Caries Prevention Of Giomer Based Sealant With And Without Pre-Treatment With Bioactive Glass Air Abrasion In Young Adults</brief_title>
    <official_title>Retention Rate And Caries Prevention Of Giomer Based Sealant With And Without Pre-Treatment With Bioactive Glass Air Abrasion In Young Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Prevention of oral diseases is preferable to treatment and is the key method of achieving&#xD;
        cost effectiveness for oral health improvement programs. Various preventive strategies for&#xD;
        dental caries have been tried and are still being developed. The occlusal pits and fissures&#xD;
        of posterior teeth are highly susceptible to caries because of the anatomy of pit and fissure&#xD;
        surfaces, which favours stagnation of bacteria and substrates. Fissure sealing has been shown&#xD;
        to be an evidence-based caries preventive method for protecting the occlusal surfaces against&#xD;
        caries. Non- sealed teeth need to be restored approximately 50% more frequently compared to&#xD;
        their sealed counterpart. Sealants are effective caries preventive agents as long as they&#xD;
        remain bonded to teeth.&#xD;
  &#xD;
        It has been proposed that sealants should be placed on both sound teeth and incipient&#xD;
        non-cavitated carious lesions on permanent teeth of high caries risk patients in order to&#xD;
        prevent the onset of caries and its progression. According to the American Dental Association&#xD;
        Guidelines for the use of pit and fissure sealants, ICDAS II codes 0, 1 and 2 are recommended&#xD;
        for sealant application.A variety of dental materials have been used as sealants using&#xD;
        different application techniques. Their effectiveness depends on the formation of a complete&#xD;
        seal and is increased by correct technique and moisture control, appropriate follow-up and&#xD;
        resealing as necessary. Resin-based conventional sealants are preferred choice, however use&#xD;
        of phosphoric acid demineralizes the enamel layer and have elongated treatment time and is&#xD;
        more technique sensitive.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        It has been proposed that sealants should be placed on both sound teeth and incipient&#xD;
        non-cavitated carious lesions on permanent teeth of high caries risk patients in order to&#xD;
        prevent the onset of caries and its progression. According to the American Dental Association&#xD;
        Guidelines for the use of pit and fissure sealants, ICDAS II codes 0, 1 and 2 are recommended&#xD;
        for sealant application. A variety of dental materials have been used as sealants using&#xD;
        different application techniques. Their effectiveness depends on the formation of a complete&#xD;
        seal and is increased by correct technique and moisture control, appropriate follow-up and&#xD;
        resealing as necessary. Resin-based conventional sealants are preferred choice, however use&#xD;
        of phosphoric acid demineralizes the enamel layer and have elongated treatment time and is&#xD;
        more technique sensitive3.&#xD;
  &#xD;
        A new bioactive hybrid material (giomer) that combined the advantages of resin composites&#xD;
        with glass ionomer cements has been introduced, it based on pre-reacted glass ionomer (PRG)&#xD;
        filler technology in which fluoroaluminosilicate glass particles that have previously reacted&#xD;
        with the polyacrylic acid were dispersed in resin. Giomer based pit and fissure sealant using&#xD;
        self-etch primer eliminates phosphoric acid etch and rinse, thus conserving the enamel and&#xD;
        reducing chair side time. However, retention of self-etch adhesive as compared to&#xD;
        conventional sealants is questionable4.&#xD;
  &#xD;
        A new method for sealant application using air- abrasive technology is less technique&#xD;
        sensitive and allows for further cleaning of the grooves prior to sealant placement. The&#xD;
        abrasive particles used in air abrasion effectively remove organic plug material from the&#xD;
        grooves and allow for deeper penetration of the sealant material into the grooves5.&#xD;
  &#xD;
        Aim of the study:&#xD;
  &#xD;
        The aim of study is to evaluate retention rate and caries prevention of giomer based sealant&#xD;
        with and without pre-treatment by bioactive glass air abrasion in young adults over one year&#xD;
  &#xD;
        PICOTS:&#xD;
  &#xD;
        (P) Patient/Population: Deep retentive fissures ( ICDAS 0,1,2) in second and third molars for&#xD;
        17-22 years old patients.&#xD;
  &#xD;
        (I) Intervention: Giomer Based Sealant With Prior BioactiveGlass Air Abrasion. (C)&#xD;
        Comparator: Giomer Based Sealant Without Prior Bioactive Glass Air Abrasion.&#xD;
  &#xD;
        (O) Outcome:&#xD;
  &#xD;
        Prioritization of Outcome&#xD;
  &#xD;
        Outcome Method of Measurement (with reference)&#xD;
  &#xD;
        Unit of Measurement&#xD;
  &#xD;
          1. ry Outcome: Loss of retention Simonsen's criteria&#xD;
  &#xD;
               -  Full retention (FR): The material was fully present on the occlusal surfaces&#xD;
  &#xD;
               -  Partially lost (PL): The material was present, but as a result of either wear or&#xD;
                  loss of the material, part of a previously sealed pit or fissure, or both, was&#xD;
                  exposed&#xD;
  &#xD;
               -  Totally lost (TL): No trace of the material was detected on the surface.&#xD;
  &#xD;
          2. ry Outcomes Secondary Caries Modified USPHS criteria7 Alpha: Absence of the caries&#xD;
             Charlie: Presence of the caries&#xD;
  &#xD;
        (T) Time :- T0 :- Baseline T1:- 3 months Study Design: Two parallel arms randomized clinical&#xD;
        trial. Study Framework: Superiority framework&#xD;
  &#xD;
        Hypothesis:&#xD;
  &#xD;
        The null hypothesis tested in this study is that there will be no difference either in the&#xD;
        retention rate or caries prevention of giomer based sealant with and without treatment by&#xD;
        bioactive glass air abrasion in young adults&#xD;
  &#xD;
        Research question:&#xD;
  &#xD;
        In deep retentive fissures, Will the use of bioactive glass air abrasion particles improve&#xD;
        the retention rate and caries prevention of the giomer based sealant?&#xD;
  &#xD;
        Methodology :&#xD;
  &#xD;
        In Group 1: the self-etch primer (BeautiSealant Primer, Shofu, Japan) will be applied to the&#xD;
        occlusal fissures with a fine micro brush. After waiting for 5 s, gently air blow for about 3&#xD;
        sec and then dry with stronger stream of air until a thin and uniform bonding layer is&#xD;
        obtained. The giomer sealant. In Group 2: occlusal surface will be subjected to 5s of&#xD;
        bioglass (AquaCare- Velopex International) , then sealant (BeautiSealant Paste, Shofu, Japan)&#xD;
        will be applied as aforementioned steps and light-cured for 20 s. In both groups, the&#xD;
        surfaces were checked with an explorer to ensure that no voids were present. The occlusion&#xD;
        was checked and, if necessary, adjusted.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">May 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2023</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>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Loss of sealant's retention</measure>
      <time_frame>6 months</time_frame>
      <description>Simonsen's criteria Full retention (FR) The material was fully present on the occlusal surfaces&#xD;
  Partially lost (PL) The material was present, but as a result of either wear or loss of the material, part of a previously sealed pit or fissure, or both, was exposed&#xD;
  - Totally lost (TL) No trace of the material was detected on the surface.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Secondary Caries</measure>
      <time_frame>6 months</time_frame>
      <description>Modified USPHS ( United States Public Health Service) criteria Alpha: Absence of the caries Charlie: Presence of the caries</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">96</enrollment>
    <condition>Dental Caries</condition>
    <arm_group>
      <arm_group_label>Giomer Based Sealant Without Pre-Treatment With Bioactive Glass Air Abrasion</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>giomer based fissure sealnt will be applied without surface treatment</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Giomer Based Sealant With Pre-Treatment With Bioactive Glass Air Abrasion</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>giomer based fissure sealnt will be applied after surface treatment With Bioactive Glass Air Abrasion</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>surface treatment with Bioactive Glass Air Abrasion</intervention_name>
      <description>giomer based fissure sealnt will be applied after surface treatment With Bioactive Glass Air Abrasion</description>
      <arm_group_label>Giomer Based Sealant With Pre-Treatment With Bioactive Glass Air Abrasion</arm_group_label>
      <arm_group_label>Giomer Based Sealant Without Pre-Treatment With Bioactive Glass Air Abrasion</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Young adult Patients Aged 17-22.&#xD;
  &#xD;
            -  Good oral hygiene (plaque index score 0 or 1).&#xD;
  &#xD;
            -  Absence of abnormal occlusion habits (e.g. bruxism, nail biting, tooth clenching and&#xD;
               mouth breathing).&#xD;
  &#xD;
            -  Patients approving to participate in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with known allergic or adverse reaction to the tested materials.&#xD;
  &#xD;
            -  Systematic disease that may affect participation.&#xD;
  &#xD;
            -  Xerostomic patients.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>17 Years</minimum_age>
      <maximum_age>22 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>yomna sayed khallaf</investigator_full_name>
      <investigator_title>lecturer at faculty of dentistry Cairo university</investigator_title>
    </responsible_party>
    <keyword>Fissure sealant</keyword>
    <keyword>Bio-active glass</keyword>
    <keyword>caries prevention</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dental Caries</mesh_term>
    </condition_browse>
    <!-- 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/NCT06003452
  org study id: Fissure sealnt
  nct id: NCT06003452
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Prevention of oral diseases is preferable to treatment and is the key method of achieving
        cost effectiveness for oral health improvement programs. Various preventive strategies for
        dental caries have been tried and are still being developed. The occlusal pits and fissures
        of posterior teeth are highly susceptible to caries because of the anatomy of pit and fissure
        surfaces, which favours stagnation of bacteria and substrates. Fissure sealing has been shown
        to be an evidence-based caries preventive method for protecting the occlusal surfaces against
        caries. Non- sealed teeth need to be restored approximately 50% more frequently compared to
        their sealed counterpart. Sealants are effective caries preventive agents as long as they
        remain bonded to teeth.
  
        It has been proposed that sealants should be placed on both sound teeth and incipient
        non-cavitated carious lesions on permanent teeth of high caries risk patients in order to
        prevent the onset of caries and its progression. According to the American Dental Association
        Guidelines for the use of pit and fissure sealants, ICDAS II codes 0, 1 and 2 are recommended
        for sealant application.A variety of dental materials have been used as sealants using
        different application techniques. Their effectiveness depends on the formation of a complete
        seal and is increased by correct technique and moisture control, appropriate follow-up and
        resealing as necessary. Resin-based conventional sealants are preferred choice, however use
        of phosphoric acid demineralizes the enamel layer and have elongated treatment time and is
        more technique sensitive.
  It has been proposed that sealants should be placed on both sound teeth and incipient
        non-cavitated carious lesions on permanent teeth of high caries risk patients in order to
        prevent the onset of caries and its progression. According to the American Dental Association
        Guidelines for the use of pit and fissure sealants, ICDAS II codes 0, 1 and 2 are recommended
        for sealant application. A variety of dental materials have been used as sealants using
        different application techniques. Their effectiveness depends on the formation of a complete
        seal and is increased by correct technique and moisture control, appropriate follow-up and
        resealing as necessary. Resin-based conventional sealants are preferred choice, however use
        of phosphoric acid demineralizes the enamel layer and have elongated treatment time and is
        more technique sensitive3.
  
        A new bioactive hybrid material (giomer) that combined the advantages of resin composites
        with glass ionomer cements has been introduced, it based on pre-reacted glass ionomer (PRG)
        filler technology in which fluoroaluminosilicate glass particles that have previously reacted
        with the polyacrylic acid were dispersed in resin. Giomer based pit and fissure sealant using
        self-etch primer eliminates phosphoric acid etch and rinse, thus conserving the enamel and
        reducing chair side time. However, retention of self-etch adhesive as compared to
        conventional sealants is questionable4.
  
        A new method for sealant application using air- abrasive technology is less technique
        sensitive and allows for further cleaning of the grooves prior to sealant placement. The
        abrasive particles used in air abrasion effectively remove organic plug material from the
        grooves and allow for deeper penetration of the sealant material into the grooves5.
  
        Aim of the study:
  
        The aim of study is to evaluate retention rate and caries prevention of giomer based sealant
        with and without pre-treatment by bioactive glass air abrasion in young adults over one year
  
        PICOTS:
  
        (P) Patient/Population: Deep retentive fissures ( ICDAS 0,1,2) in second and third molars for
        17-22 years old patients.
  
        (I) Intervention: Giomer Based Sealant With Prior BioactiveGlass Air Abrasion. (C)
        Comparator: Giomer Based Sealant Without Prior Bioactive Glass Air Abrasion.
  
        (O) Outcome:
  
        Prioritization of Outcome
  
        Outcome Method of Measurement (with reference)
  
        Unit of Measurement
  
          1. ry Outcome: Loss of retention Simonsen's criteria
  
               -  Full retention (FR): The material was fully present on the occlusal surfaces
  
               -  Partially lost (PL): The material was present, but as a result of either wear or
                  loss of the material, part of a previously sealed pit or fissure, or both, was
                  exposed
  
               -  Totally lost (TL): No trace of the material was detected on the surface.
  
          2. ry Outcomes Secondary Caries Modified USPHS criteria7 Alpha: Absence of the caries
             Charlie: Presence of the caries
  
        (T) Time :- T0 :- Baseline T1:- 3 months Study Design: Two parallel arms randomized clinical
        trial. Study Framework: Superiority framework
  
        Hypothesis:
  
        The null hypothesis tested in this study is that there will be no difference either in the
        retention rate or caries prevention of giomer based sealant with and without treatment by
        bioactive glass air abrasion in young adults
  
        Research question:
  
        In deep retentive fissures, Will the use of bioactive glass air abrasion particles improve
        the retention rate and caries prevention of the giomer based sealant?
  
        Methodology :
  
        In Group 1: the self-etch primer (BeautiSealant Primer, Shofu, Japan) will be applied to the
        occlusal fissures with a fine micro brush. After waiting for 5 s, gently air blow for about 3
        sec and then dry with stronger stream of air until a thin and uniform bonding layer is
        obtained. The giomer sealant. In Group 2: occlusal surface will be subjected to 5s of
        bioglass (AquaCare- Velopex International) , then sealant (BeautiSealant Paste, Shofu, Japan)
        will be applied as aforementioned steps and light-cured for 20 s. In both groups, the
        surfaces were checked with an explorer to ensure that no voids were present. The occlusion
        was checked and, if necessary, adjusted.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Loss of sealant's retention
  time frame: 6 months
  description: Simonsen's criteria Full retention (FR) The material was fully present on the occlusal surfaces
  Partially lost (PL) The material was present, but as a result of either wear or loss of the material, part of a previously sealed pit or fissure, or both, was exposed
  - Totally lost (TL) No trace of the material was detected on the surface.
  measure: Secondary Caries
  time frame: 6 months
  description: Modified USPHS ( United States Public Health Service) criteria Alpha: Absence of the caries Charlie: Presence of the caries
  arm group label: Giomer Based Sealant Without Pre-Treatment With Bioactive Glass Air Abrasion
  arm group type: Active Comparator
  description: giomer based fissure sealnt will be applied without surface treatment
  arm group label: Giomer Based Sealant With Pre-Treatment With Bioactive Glass Air Abrasion
  arm group type: Experimental
  description: giomer based fissure sealnt will be applied after surface treatment With Bioactive Glass Air Abrasion
  intervention type: Procedure
  intervention name: surface treatment with Bioactive Glass Air Abrasion
  description: giomer based fissure sealnt will be applied after surface treatment With Bioactive Glass Air Abrasion
  arm group label: Giomer Based Sealant With Pre-Treatment With Bioactive Glass Air Abrasion
  arm group label: Giomer Based Sealant Without Pre-Treatment With Bioactive Glass Air Abrasion
  criteria: 
  gender: All
  minimum age: 17 Years
  maximum age: 22 Years
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: yomna sayed khallaf
  investigator title: lecturer at faculty of dentistry Cairo university
  mesh term: Dental Caries