<?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>IRCT2017070534903N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-09-18</date_registration>
      <primary_sponsor>Endodontology Research Center, Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Effect of non-acidic diet in treating dentin hypersensitivity: A randomized clinical trial double bind</public_title>
      <acronym></acronym>
      <scientific_title>The impact of acidic foodstuff on dentine hypersensitivity in treatment with anti hypersensitivity toothpaste among patients of Kerman school of dentistry</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26549</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Dentin hypersensivity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group, treatment packages, contain soft Oral-B tooth brush and Sensodyne toothpaste And contained a brochure on diet and food.After the initial examinations, the patient was asked Which uses toothbrushes and toothpastes inside the package for 4 weeks, Using foodstuff and drinks with high acidity level is not allowed during 4 weeks. Therefore, forbidden foodstuffs in this this period are as followed : 1. acid drinks ( beverage , beer, fizzy and not fizzy yogurt drinks ) 2. greek yogurt or very sour yogurt 3. whey and qarequrut 4. pickles and salty stuff (anything that contains vinegar, such as pickled cucumber, salad sauce ...) 5. citrus ( drinking citrus juice by using straw, the way that straw is placed at the end of the mouth and the juice does not contact the teeth, does not make any problem in the process of treatment) 6. lemon juice and verjuice. Intervention 2: Control group, treatment packages, contain soft Oral-B tooth brush and Sensodyne toothpaste.After the initial examinations, the patient was asked Which uses toothbrushes and toothpastes inside the package for 4 weeks.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Akhavan Fard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shafa street</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 34 3246 6839</telephone>
        <email>fatemeh.akhavanfard@gmail.com</email>
        <affiliation>School of Dentistry</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Faeze Hamze</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shafa street</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 34 3247 6498</telephone>
        <email>faeze.hamze@gmail.com</email>
        <affiliation>School of Dentistry</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: patients age must be within the range of 18-70; in the first session of examinations, patients must have at least two teeth with dentin hypersensitivity in which erosion or abrasion in cervical region or gingival recession is exposed; initially, in response to cold air stimulator, patients must choose 2 or 3 in Schiff scale and choose within the range of 30 to 80 milli metes (3 to 8) in visual analogue scale pain intensity specifier, then after 10 minutes, using ice spray and putting it in buccal surface, we ask the patients to specify the intensity of pain based on visual analogue scale; mentioned teeth must not have looseness degree greater than one; Gingival Index must be equal or lower than one in the teeth under consideration; patients access and control must be available within the four week period of treatment.&#13;
Exclusion criteria: people with systemic diseases (people with high blood pressure or diabetic ones who are under control are excepted ); ladies who are in the period of pregnancy or breast feeding; people who have used anti epilepsy, anti inflammation, anti histamine, anti depression, anodyne, tranquilizer or sedative drugs daily, in the recent month or have to use during the period of study; people with chronic or advanced periodental or dental pathologic diseases; teeth with partial prosthesis, teeth with wide restoration such as crowned teeth, suspected to pulpit, enamel caries or cracking; people who have used dentin hypersensitivity reduction treatment like anti hypersensitivity toothpaste in the recent eight weeks; patients who have had periodental surgery orthodontic treatment in the recent three months.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K03.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified diseases of hard tissues of teeth</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group, treatment packages, contain soft Oral-B tooth brush and Sensodyne toothpaste And contained a brochure on diet and food.After the initial examinations, the patient was asked Which uses toothbrushes and toothpastes inside the package for 4 weeks, Using foodstuff and drinks with high acidity level is not allowed during 4 weeks. Therefore, forbidden foodstuffs in this this period are as followed : 1. acid drinks ( beverage , beer, fizzy and not fizzy yogurt drinks ) 2. greek yogurt or very sour yogurt 3. whey and qarequrut 4. pickles and salty stuff (anything that contains vinegar, such as pickled cucumber, salad sauce ...) 5. citrus ( drinking citrus juice by using straw, the way that straw is placed at the end of the mouth and the juice does not contact the teeth, does not make any problem in the process of treatment) 6. lemon juice and verjuice</i_keyword>
      <i_keyword>Control group, treatment packages, contain soft Oral-B tooth brush and Sensodyne toothpaste.After the initial examinations, the patient was asked Which uses toothbrushes and toothpastes inside the package for 4 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain amount in the first examination and before intervention. Timepoint: At the beginning of the study in the primary examination. Method of measurement: visual analog scale Marking on the line with standard length.</prim_outcome>
      <prim_outcome>Pain amount in the first examination and before intervention. Timepoint: At the beginning of the study in the primary examination. Method of measurement: Schiff criteria Degree 0: patient does not answer to the air stimulator , degree 1: patient answers to the air stimulator but does not ask for its stop, degree 2: patient answers to the air stimulator and ask for its stop or dispalcement, degree 3: patient answers to the air stimulator, finds it painful and ask for its stop.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Visual analogue scale degree in the final examination and before intervention. Timepoint: 4 weeks. Method of measurement: Marking on the line with standard length (pain amount identifier).</sec_outcome>
      <sec_outcome>Schiff criteria degree in the final examination and after intervention. Timepoint: 4 weeks. Method of measurement: Degree 0: patient does not answer to the air stimulator , degree 1: patient answers to the air stimulator but does not ask for its stop, degree 2: patient answers to the air stimulator and ask for its stop or dispalcement, degree 3: patient answers to the air stimulator, finds it painful and ask for its stop.</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>Endodontology Research Center, Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-10</approval_date>
        <contact_name>Kerman University of Medical Sciences</contact_name>
        <contact_address>Ebne Sina street, Jahad boulevard, Somaye (Tahmasb Abad) corssroads Kerman  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
