<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/NCT03774498</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2018-11-22</org_study_id>
    <nct_id>NCT03774498</nct_id>
  </id_info>
  <brief_title>Effect of Different Over-the-counter Toothpastes on Enamel Remineralization</brief_title>
  <acronym>RCT</acronym>
  <official_title>Effect of Different Over-the-counter Toothpastes on Enamel Remineralization: A Double Blinded Randomized Clinical Trial</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 study will be conducted to compare between recent over-the-counter toothpaste (Novamin &amp;&#xD;
      Fluoride) and regular over-the-counter toothpaste (Sodium Fluoride) in remineralization&#xD;
      potential, so as to be able to know which of the toothpastes will have a better&#xD;
      remineralization potential on demineralized enamel.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Statement of problem:&#xD;
&#xD;
      Dental caries has been recognized as a dynamic process that results from an imbalance between&#xD;
      the physiologic demineralization and remineralization of tooth structure. It has been well&#xD;
      established that tooth undergoes cyclic demineralization of enamel crystals with periods of&#xD;
      remineralization resulting from re-precipitation of calcium and phosphate ions from the&#xD;
      saliva. If the process of demineralization dominates, caries result. However, if&#xD;
      remineralization dominates along with removal of bacterial infection, enamel integrity gets&#xD;
      restored. This basic knowledge of carious process brings us to an understanding that by&#xD;
      controlling the amount, pattern and rhythm of demineralization and remineralization, carious&#xD;
      lesions can either be controlled from progressing further or can be reversed. Several decades&#xD;
      ago it was noted that clinically detectable white-spot lesions could be hardened; various&#xD;
      scientific methods have been advocated for arrest and the reversal of incipient caries lesion&#xD;
      by either decreasing the solubility of the mineral present or by increasing the mineral&#xD;
      content of the previously demineralized tooth. Since remineralization occurring naturally in&#xD;
      oral environment is often inadequate for maintaining strong decay free enamel and dentin, the&#xD;
      process needs to be augmented by using some external means. It has been proposed that a&#xD;
      simultaneous supply of calcium, phosphate and fluoride ions might serve as an invaluable tool&#xD;
      to remineralize and strengthen the tooth structure by formation of calcium fluorapatite.&#xD;
      Fluoride as a constituent of drinking water and in the form of various topically applied&#xD;
      products especially over-the-counter toothpastes have a long successful history of use as a&#xD;
      caries preventive agent.&#xD;
&#xD;
      NovaMin is claimed to release calcium and phosphate ions intraorally to help the self-repair&#xD;
      process of enamel. A silica-rich surface layer forms through poly-condensation of hydrated&#xD;
      silica groups on which precipitation of ions happens which crystallizes over time to form a&#xD;
      hydroxyl-carbonate apatite. Although it is used extensively as a desensitizing agent reports&#xD;
      also claim that the chemical reactions that promote apatite formation may enhance the&#xD;
      remineralization. But there is limited clinical research to ascertain if there is any&#xD;
      synergistic effect on combining anti-cariogenic activity of fluoride ions with these&#xD;
      remineralization systems.&#xD;
&#xD;
      Direct benefit of the research to the human volunteer:&#xD;
&#xD;
        -  Have better remineralization for initial white spot carious lesions using recent Novamin&#xD;
           technology.&#xD;
&#xD;
        -  Gain the other advantages for Novamin technology on the gingival health as well as&#xD;
           dental health.&#xD;
&#xD;
        -  Patient will know the proper brushing technique as he would be given instructions about&#xD;
           this during the study.&#xD;
&#xD;
        -  Patient will get to know the difference in efficiency of different over-the-counter&#xD;
           toothpastes especially those assigned in the investigator's study.&#xD;
&#xD;
      Scientific value and social Benefits:&#xD;
&#xD;
        -  Determine whether the new Novamin technology results are worth and have good efficient&#xD;
           remineralization potential or not.&#xD;
&#xD;
        -  Know more conservative mean for repair of demineralized areas in teeth.&#xD;
&#xD;
        -  Have proper data base about difference in over-the-counter toothpastes.&#xD;
&#xD;
      Research question:&#xD;
&#xD;
      Will recent over-the-counter toothpaste (Novamin &amp; Fluoride) be better than regular&#xD;
      over-the-counter toothpaste (Sodium Fluoride) in remineralization of white spot lesions in&#xD;
      adult patients who are having initial white spot carious lesions?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">April 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2019</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>Sequential Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Enamel remineralization</measure>
    <time_frame>8 weeks</time_frame>
    <description>Decalcification index: (0):No white spot ,(1):Visible white spots ,no surface interruption (mild),(2):Visible white spot with roughened surface,not require restoration (moderate),(3):Visible with surface interruption (severe), (4):Cavitation.&#xD;
International Caries Detection and Assessment System:(0):Sound tooth surface: No evidence of caries after 5 sec air drying ,(1):First visual change in enamel: Opacity or white or brown discoloration visible after prolonged drying,(2):Distinct change in enamel visible when wet, must be visible when dry,(3):Localized enamel breakdown (no visual signs of dentin involvement) seen when wet and after prolonged drying,(4):Underlying dark shadow from dentine,(5):Distinct cavity with visible dentine,(6): Extensive (more than half the surface) cavity with visible dentine.&#xD;
Scoring is done by photographs at the beginning and at follow-up visits with the same setting each time.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">52</enrollment>
  <condition>Enamel Caries</condition>
  <arm_group>
    <arm_group_label>Sensodyne repair and protect</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>NovaMin &amp; fluoride toothpaste</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sensodyne Daily Care Toothpaste 0.315%</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Sodium fluoride toothpaste</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sensodyne repair and protect</intervention_name>
    <description>NovaMin &amp; fluoride toothpaste</description>
    <arm_group_label>Sensodyne repair and protect</arm_group_label>
    <other_name>no other names</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients having at least two permanent tooth surfaces having white spot lesions&#xD;
             (buccal/facial aspects of incisors, canines or pre-molars).&#xD;
&#xD;
          -  Subjects with orthodontic appliances.&#xD;
&#xD;
          -  Systemically healthy subjects of both genders, between the ages of 18 to 45 years, who&#xD;
             were well versed with the use of toothbrush and dentifrice for oral hygiene&#xD;
             maintenance, will be considered for the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presently on desensitizing treatment.&#xD;
&#xD;
          -  Subjects with bridge work that may interfere with evaluation.&#xD;
&#xD;
          -  Medical histories that may compromise study protocol.(including psychiatric and&#xD;
             pharmaco-therapeutic problems)&#xD;
&#xD;
          -  Allergies.&#xD;
&#xD;
          -  Systemic conditions which are etiologic/predisposing to dentinal hypersensitivity&#xD;
             (Enamel and dentine genetic abnormalities).&#xD;
&#xD;
          -  Eating disorders.&#xD;
&#xD;
          -  Pregnancy or breast feeding.&#xD;
&#xD;
          -  Any other pathology.&#xD;
&#xD;
          -  Known history of allergies to toothpaste contents.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Omyma Safwat, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohammed F. Abd El-Khalek, Dentist</last_name>
    <phone>01101000457</phone>
    <phone_ext>02</phone_ext>
    <email>mohammed.farag@dentistry.cu.edu.eg</email>
  </overall_contact>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>December 12, 2018</last_update_submitted>
  <last_update_submitted_qc>December 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Mohammed Farag Abd El-Khalek kelany</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03774498
org study id: CEBD-CU-2018-11-22
nct id: NCT03774498
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will be conducted to compare between recent over-the-counter toothpaste (Novamin &
      Fluoride) and regular over-the-counter toothpaste (Sodium Fluoride) in remineralization
      potential, so as to be able to know which of the toothpastes will have a better
      remineralization potential on demineralized enamel.
Statement of problem:

      Dental caries has been recognized as a dynamic process that results from an imbalance between
      the physiologic demineralization and remineralization of tooth structure. It has been well
      established that tooth undergoes cyclic demineralization of enamel crystals with periods of
      remineralization resulting from re-precipitation of calcium and phosphate ions from the
      saliva. If the process of demineralization dominates, caries result. However, if
      remineralization dominates along with removal of bacterial infection, enamel integrity gets
      restored. This basic knowledge of carious process brings us to an understanding that by
      controlling the amount, pattern and rhythm of demineralization and remineralization, carious
      lesions can either be controlled from progressing further or can be reversed. Several decades
      ago it was noted that clinically detectable white-spot lesions could be hardened; various
      scientific methods have been advocated for arrest and the reversal of incipient caries lesion
      by either decreasing the solubility of the mineral present or by increasing the mineral
      content of the previously demineralized tooth. Since remineralization occurring naturally in
      oral environment is often inadequate for maintaining strong decay free enamel and dentin, the
      process needs to be augmented by using some external means. It has been proposed that a
      simultaneous supply of calcium, phosphate and fluoride ions might serve as an invaluable tool
      to remineralize and strengthen the tooth structure by formation of calcium fluorapatite.
      Fluoride as a constituent of drinking water and in the form of various topically applied
      products especially over-the-counter toothpastes have a long successful history of use as a
      caries preventive agent.

      NovaMin is claimed to release calcium and phosphate ions intraorally to help the self-repair
      process of enamel. A silica-rich surface layer forms through poly-condensation of hydrated
      silica groups on which precipitation of ions happens which crystallizes over time to form a
      hydroxyl-carbonate apatite. Although it is used extensively as a desensitizing agent reports
      also claim that the chemical reactions that promote apatite formation may enhance the
      remineralization. But there is limited clinical research to ascertain if there is any
      synergistic effect on combining anti-cariogenic activity of fluoride ions with these
      remineralization systems.

      Direct benefit of the research to the human volunteer:

        -  Have better remineralization for initial white spot carious lesions using recent Novamin
           technology.

        -  Gain the other advantages for Novamin technology on the gingival health as well as
           dental health.

        -  Patient will know the proper brushing technique as he would be given instructions about
           this during the study.

        -  Patient will get to know the difference in efficiency of different over-the-counter
           toothpastes especially those assigned in the investigator's study.

      Scientific value and social Benefits:

        -  Determine whether the new Novamin technology results are worth and have good efficient
           remineralization potential or not.

        -  Know more conservative mean for repair of demineralized areas in teeth.

        -  Have proper data base about difference in over-the-counter toothpastes.

      Research question:

      Will recent over-the-counter toothpaste (Novamin & Fluoride) be better than regular
      over-the-counter toothpaste (Sodium Fluoride) in remineralization of white spot lesions in
      adult patients who are having initial white spot carious lesions?
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Prevention
masking: Double (Participant, Care Provider)
measure: Enamel remineralization
time frame: 8 weeks
description: Decalcification index: (0):No white spot ,(1):Visible white spots ,no surface interruption (mild),(2):Visible white spot with roughened surface,not require restoration (moderate),(3):Visible with surface interruption (severe), (4):Cavitation.
International Caries Detection and Assessment System:(0):Sound tooth surface: No evidence of caries after 5 sec air drying ,(1):First visual change in enamel: Opacity or white or brown discoloration visible after prolonged drying,(2):Distinct change in enamel visible when wet, must be visible when dry,(3):Localized enamel breakdown (no visual signs of dentin involvement) seen when wet and after prolonged drying,(4):Underlying dark shadow from dentine,(5):Distinct cavity with visible dentine,(6): Extensive (more than half the surface) cavity with visible dentine.
Scoring is done by photographs at the beginning and at follow-up visits with the same setting each time.
arm group label: Sensodyne repair and protect
arm group type: Active Comparator
description: NovaMin & fluoride toothpaste
arm group label: Sensodyne Daily Care Toothpaste 0.315%
arm group type: No Intervention
description: Sodium fluoride toothpaste
intervention type: Drug
intervention name: Sensodyne repair and protect
description: NovaMin & fluoride toothpaste
arm group label: Sensodyne repair and protect
other name: no other names
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Omyma Safwat, Professor
role: Study Director
affiliation: Cairo University
last name: Mohammed F. Abd El-Khalek, Dentist
phone: 01101000457
phone ext: 02
email: mohammed.farag@dentistry.cu.edu.eg
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Mohammed Farag Abd El-Khalek kelany
investigator title: Principal investigator
sharing ipd: Undecided