<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/NCT03823612</url>
  </required_header>
  <id_info>
    <org_study_id>donia mahmoud</org_study_id>
    <nct_id>NCT03823612</nct_id>
  </id_info>
  <brief_title>Reminerlization Potential of Innovative Biomimetic Material in Caries White Spot Lesions</brief_title>
  <official_title>Reminerlization Potential of Innovative Biomimetic Material Versus Casein Phosphopeptide-amorphous Calcium Phosphate in Caries White Spot Lesions &quot;A Randomized Clinical Trial&quot;</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>
      to remineralize the white spot caries lesions after orthodontic treatment , the investigator&#xD;
      will use two different materials ( Clinpro tooth creme versus Gc tooth mousse) and will&#xD;
      compare between their effects in remineralization of white spot caries lesions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dental caries is the localized destruction of tooth tissues by acids, especially lactic acid,&#xD;
      produced by the fermentation of dietary carbohydrates by bacteria in dental plaque.&#xD;
      Demineralization can be arrested or reversed when remineralization agents are applied to&#xD;
      incipient carious or non-cavitated carious lesions. A large number of therapeutic agents&#xD;
      including non-fluoridated products have been developed to promote enamel remineralization.&#xD;
      The process of restoring lost mineral ions to the tooth structure and strengthening the&#xD;
      lattice work is known as remineralization.&#xD;
&#xD;
      The development of decalcification around orthodontic brackets and bands, commonly called&#xD;
      white spot lesions (WSLs), is often observed in patients with poor oral hygiene during&#xD;
      treatment .In many instances, these WSLs continue to be visible after the removal of fixed&#xD;
      appliances and after natural remineralization. The remineralized enamel crystallites are&#xD;
      generally more resistant to decalcification and also have the same orientation as the&#xD;
      original enamel crystallites. The early enamel lesions have a potential for remineralization&#xD;
      with an increased resistance to further acid challenge, particularly with the use of enhanced&#xD;
      remineralization treatments.&#xD;
&#xD;
      Recaldent™ is derived from the milk protein, casein. For many years it has been known that&#xD;
      milk and its derivatives have a tooth protective effect. Research has shown that this&#xD;
      activity is due to a part of the casein protein called Casein Phosphopeptide (or CPP), which&#xD;
      carries calcium and phosphate ions in the form of Amorphous Calcium Phosphate (or ACP) which&#xD;
      used in reminerlization of white spot caries lesions.&#xD;
&#xD;
      Clinpro tooth crème (3M ESPE) is a 0.21% w/w sodium fluoride (NaF) anti caries dentifrice&#xD;
      that contains 950 ppm fluoride and a functionalized tricalcium phosphate (f-TCP)&#xD;
      ingredient.One major advantage of this calcium phosphate system is that it is stable in&#xD;
      aqueous environment and also does not affect the fluoride activity added in the dentifrices.&#xD;
      Furthermore,it has been suggested that fluoride combination with f-TCP not only provides&#xD;
      greater remineralization in terms of microhardness and fluoride uptake, but also decreases&#xD;
      the dose of fluoride required to achieve the same degree of remineralization,&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">March 1, 2019</start_date>
  <completion_date type="Anticipated">October 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2019</primary_completion_date>
  <phase>Phase 4</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>esthetic assessment</measure>
    <time_frame>baseline, after 1 month , 3 months and 6 months of the application</time_frame>
    <description>Spectrophotometer ( L, a, b) will be used to measure the change in the shade of the white spot lesions during the study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>patient compliance</measure>
    <time_frame>6 months</time_frame>
    <description>The participants compliance will be detected by a questionnaire by asking the patient to describe his satisfaction to the total outcome of our intervention by giving a score from 1-10</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">34</enrollment>
  <condition>White Spot Lesion of Tooth</condition>
  <arm_group>
    <arm_group_label>GC tooth mousse</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: GC tooth mousse it contains complex of Casein Phosphopeptide,Amorphous Calcium Phosphate ( CPP-ACP ) other name: Tooth Mousse (Bio-available calcium and phosphate, without fluoride)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>clinpro tooth creme</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>it contains 0.21% Sodium Fluoride, Anti-Cavity Paste is an advanced formula containing an innovative tri-calcium phosphate ingredient&#xD;
other name:0.21% w/w Sodium Fluoride Anti-Cavity Paste with Tri-Calcium Phosphate</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clinpro Tooth Creme</intervention_name>
    <description>The participant will be instructed to Place a pea-sized amount of Clinpro Tooth Crème on a soft bristled toothbrush and brush teeth for at least two minutes then after brushing the patient will rinse out his mouth with water and spit out. It will be used twice daily at first in the morning and before sleep.</description>
    <arm_group_label>clinpro tooth creme</arm_group_label>
    <other_name>Anti-Cavity Paste with Tri-Calcium Phosphate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GC tooth mousse</intervention_name>
    <description>The participant will be instructed to squeeze a small amount of GC Tooth Mousse out onto a clean finger. A cotton tip, swab or custom tray are suitable application methods as it will Applied directly onto his tooth surfaces and leave undisturbed for three minutes then he will be instructed to Spread any residual crème around the mouth with his tongue and hold for a further one to two minutes then the participant will expectorate thoroughly and if possible he should avoid rinsing. Any GC Tooth Mousse remaining in the mouth can be left to gradually dissipate. The participant will be instructed to avoid eating or drinking for 30 minutes following application.</description>
    <arm_group_label>GC tooth mousse</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients should have at least one white spot caries lesion&#xD;
&#xD;
          -  age from 18 to 40 years&#xD;
&#xD;
          -  no gender restriction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a compromised medical history.&#xD;
&#xD;
          -  Severe or active periodontal disease&#xD;
&#xD;
          -  Patients with developmental hypo-calcified lesions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Donia Mahmoud Abd El Moaty</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>donia mahmoud abd el moaty, bachelor</last_name>
      <phone>01220767085</phone>
      <email>donia.atta@dentistry@cu.edu.eg</email>
    </contact>
    <contact_backup>
      <last_name>nada hamada ahmed, bachelor</last_name>
      <phone>01000523663</phone>
      <email>nadahamada38@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>donia mahmoud abd el moaty; Doniamahmoud17@gmail.com</investigator_full_name>
    <investigator_title>principle investigator in cairo university</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03823612
org study id: donia mahmoud
nct id: NCT03823612
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
to remineralize the white spot caries lesions after orthodontic treatment , the investigator
      will use two different materials ( Clinpro tooth creme versus Gc tooth mousse) and will
      compare between their effects in remineralization of white spot caries lesions.
Dental caries is the localized destruction of tooth tissues by acids, especially lactic acid,
      produced by the fermentation of dietary carbohydrates by bacteria in dental plaque.
      Demineralization can be arrested or reversed when remineralization agents are applied to
      incipient carious or non-cavitated carious lesions. A large number of therapeutic agents
      including non-fluoridated products have been developed to promote enamel remineralization.
      The process of restoring lost mineral ions to the tooth structure and strengthening the
      lattice work is known as remineralization.

      The development of decalcification around orthodontic brackets and bands, commonly called
      white spot lesions (WSLs), is often observed in patients with poor oral hygiene during
      treatment .In many instances, these WSLs continue to be visible after the removal of fixed
      appliances and after natural remineralization. The remineralized enamel crystallites are
      generally more resistant to decalcification and also have the same orientation as the
      original enamel crystallites. The early enamel lesions have a potential for remineralization
      with an increased resistance to further acid challenge, particularly with the use of enhanced
      remineralization treatments.

      Recaldent™ is derived from the milk protein, casein. For many years it has been known that
      milk and its derivatives have a tooth protective effect. Research has shown that this
      activity is due to a part of the casein protein called Casein Phosphopeptide (or CPP), which
      carries calcium and phosphate ions in the form of Amorphous Calcium Phosphate (or ACP) which
      used in reminerlization of white spot caries lesions.

      Clinpro tooth crème (3M ESPE) is a 0.21% w/w sodium fluoride (NaF) anti caries dentifrice
      that contains 950 ppm fluoride and a functionalized tricalcium phosphate (f-TCP)
      ingredient.One major advantage of this calcium phosphate system is that it is stable in
      aqueous environment and also does not affect the fluoride activity added in the dentifrices.
      Furthermore,it has been suggested that fluoride combination with f-TCP not only provides
      greater remineralization in terms of microhardness and fluoride uptake, but also decreases
      the dose of fluoride required to achieve the same degree of remineralization,
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: esthetic assessment
time frame: baseline, after 1 month , 3 months and 6 months of the application
description: Spectrophotometer ( L, a, b) will be used to measure the change in the shade of the white spot lesions during the study
measure: patient compliance
time frame: 6 months
description: The participants compliance will be detected by a questionnaire by asking the patient to describe his satisfaction to the total outcome of our intervention by giving a score from 1-10
arm group label: GC tooth mousse
arm group type: Experimental
description: Drug: GC tooth mousse it contains complex of Casein Phosphopeptide,Amorphous Calcium Phosphate ( CPP-ACP ) other name: Tooth Mousse (Bio-available calcium and phosphate, without fluoride)
arm group label: clinpro tooth creme
arm group type: Active Comparator
description: it contains 0.21% Sodium Fluoride, Anti-Cavity Paste is an advanced formula containing an innovative tri-calcium phosphate ingredient
other name:0.21% w/w Sodium Fluoride Anti-Cavity Paste with Tri-Calcium Phosphate
intervention type: Drug
intervention name: Clinpro Tooth Creme
description: The participant will be instructed to Place a pea-sized amount of Clinpro Tooth Crème on a soft bristled toothbrush and brush teeth for at least two minutes then after brushing the patient will rinse out his mouth with water and spit out. It will be used twice daily at first in the morning and before sleep.
arm group label: clinpro tooth creme
other name: Anti-Cavity Paste with Tri-Calcium Phosphate
intervention type: Drug
intervention name: GC tooth mousse
description: The participant will be instructed to squeeze a small amount of GC Tooth Mousse out onto a clean finger. A cotton tip, swab or custom tray are suitable application methods as it will Applied directly onto his tooth surfaces and leave undisturbed for three minutes then he will be instructed to Spread any residual crème around the mouth with his tongue and hold for a further one to two minutes then the participant will expectorate thoroughly and if possible he should avoid rinsing. Any GC Tooth Mousse remaining in the mouth can be left to gradually dissipate. The participant will be instructed to avoid eating or drinking for 30 minutes following application.
arm group label: GC tooth mousse
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: donia mahmoud abd el moaty; Doniamahmoud17@gmail.com
investigator title: principle investigator in cairo university
mesh term: Calcium