<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20110823007402N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-23</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of nano hydroxyapatite toothpaste and mouthwash on enamel and dentin erosion</public_title>
      <acronym></acronym>
      <scientific_title>Effect of nano hydroxyapatite toothpastes and mouth rinse on eroded enamel and dentin - an in situ study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>21</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68101</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple randomization, block. The size of all the blocks will be equal. Sequence generation software is also used for randomization. Sequentially numbered, sealed, opaque envelopes are used for random concealment. In this method, each random sequence created is recorded on a card and the cards inside and the letter envelopes are placed in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of starting the registration of participants, based on the order in which eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed, Blinding description: The size of all the blocks will be equal. Sequence generation software is also used for randomization. Sequentially numbered, sealed, opaque envelopes are used for random concealment. In this method, each random sequence created is recorded on a card and the cards inside and the letter envelopes are placed in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of starting the registration of participants, based on the order in which eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed.</study_design>
      <phase>3</phase>
      <hc_freetext>enamel and dentin erosion.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group (positive control): using Elmex ® erosion protection toothpaste (GABA International AG, Therwil, Switzerland) containing 3500 ppm of tin ions in the form of tin chloride and 1400 ppm of fluoride ions with pH = 4.5. followed by Elmex® erosion protection mouthwash containing 800 ppm of tin ions in the form of tin chloride and 500 ppm of fluoride ions with pH = 4.5. The second intervention group: using Vitis® anticaries toothpaste with nanorepair (VITIS Oral HealthC/O Dent- O-Care, London, UK) containing 1450 ppm fluoride ions in sodium monofluorophosphate, 0.45% nanohydroxyapatite and 10% xylitol. Then using Vitis® anticaries mouthwash containing 1450 ppm fluoride ions in sodium monofluorophosphate, 0.45% nanohydroxyapatite and 10% xylitol. Intervention 2: Control group: In this group, distilled water is used (appliance without using toothpaste).</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information exists</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahtab Memarpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental school, Ghomabad, Ghasrodasht</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15878- 71956</zip>
        <telephone>+98 71 1626 3192</telephone>
        <email>memarpour@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahtab Memarpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental school, Ghomabad, Ghasrodasht</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15878- 71956</zip>
        <telephone>+98 71 1626 3192</telephone>
        <email>memarpour@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1) Being at least 18 years old                                                                   2) Having good general and oral health                                             3) Not being allergic to certain substances including oral hygiene products or dental materials                                                                  4) Non-stimulated and stimulated saliva flow more than 0.25 ml/min and more than 0.25 ml/min, respectively.                                                   5) The absence of active caries lesions or non-carious lesions such as cervical lesions and periodontal disease                                  6) The absence of dental prostheses and orthodontic appliances   7) The absence of erosive lesions in the teeth                                       8) The possibility of visiting at recalls.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1) Pregnancy or intention to become pregnant during the study            2) Breastfeeding                                                                                                3) Simultaneous participation in another study                                                 4) Professional use of fluoride in the last two months                                     5) Inability to implement the study protocols                                        6) Receiving medical treatment                                                              7) Using drugs that Interference with the flow of saliva                                   8) Having digestive problems                                                                      9) Smoking</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K03.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Erosion of teeth</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group (positive control): using Elmex ® erosion protection toothpaste (GABA International AG, Therwil, Switzerland) containing 3500 ppm of tin ions in the form of tin chloride and 1400 ppm of fluoride ions with pH = 4.5. followed by Elmex® erosion protection mouthwash containing 800 ppm of tin ions in the form of tin chloride and 500 ppm of fluoride ions with pH = 4.5. The second intervention group: using Vitis® anticaries toothpaste with nanorepair (VITIS Oral HealthC/O Dent- O-Care, London, UK) containing 1450 ppm fluoride ions in sodium monofluorophosphate, 0.45% nanohydroxyapatite and 10% xylitol. Then using Vitis® anticaries mouthwash containing 1450 ppm fluoride ions in sodium monofluorophosphate, 0.45% nanohydroxyapatite and 10% xylitol.</i_keyword>
      <i_keyword>Control group: In this group, distilled water is used (appliance without using toothpaste).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Surface microhardness, roughness and surface wear. Timepoint: 5 days after the erosive/abrasive challenge. Method of measurement: Measuring surface wear with contact profilometry, surface hardness using Vickers test, surface roughness with atomic force microscope.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-19</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Administration Building of Shiraz University of Medical Sciences  Zand St., Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
