<?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>IRCT138709301509N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2009-05-03</date_registration>
      <primary_sponsor>Vice-chancellor for Research, Mashhad and Tabriz Universities of Medical Sciences.</primary_sponsor>
      <public_title>Clinical evaluation of three adhesive systems for the restoration of non-carious cervical lesions</public_title>
      <acronym></acronym>
      <scientific_title>Clinical evaluation of three adhesive systems for the restoration of non-carious cervical lesions</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2008-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/795</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Other design features: All restorations will be done by One operator. &#13;
Two examiners will recall and examine the restorations.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Noncarious cervical lesions. Condition 2: Noncarious Cervical Lesions.</hc_freetext>
      <i_freetext>Intervention 1: Seventh Generation, One step, Optibond All-in-One (Kerr). Intervention 2: Fifth Generation, Total-etch, two step, OptiBond Solo (Kerr). Intervention 3: Fourth generation, total-etch, three steps, OptiBond FL(Kerr).</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>Dr. Horieh Moosavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of operative dentistry, Dental School, Blv. Vakil Abad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>91735</zip>
        <telephone>+98 51 1882 9506</telephone>
        <email>moosavih@mums.ac.ir  or  dentist_57@yahoo.com</email>
        <affiliation>Dental Research Center of Mashhad Dental School</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Horieh Moosavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of operative dentistry, Dental School, Blv. Vakil Abad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>91735</zip>
        <telephone>+98 51 1882 9506</telephone>
        <email>moosavi@mums.ac.ir   or  dentist_57@yahoo.com</email>
        <affiliation>Dental Research Center of Mashhad Dental School</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: Age 20 to 50 years, signing informed consent prior to commencement of any treatment, Presence of at least have three NCCLs, having contact with opposite teeth without any high occlusion stress for selected teeth, cavity cervical margins placed on cementum with no more than 50% put on enamel, assessable isolation and observable and easily accessible gingival margins during tooth restoration, &#13;
Exclusion Criteria: Any systemic disease, any periodontal disease, history of periodontal surgery three months prior to study, poor oral hygiene, treatment with anti sensitivity materials such as desensitizer dentifrices, high-risk caries, cervical lesions with caries and restricted to the labial area with extending to proximal surfaces, cervical lesions with severe degree of sclerosis, presence of any caries or restorations except in cervical area of the tooth labial portion, the deep of cervical lesion more than 2 mm (probe measurement), depth of lesion more than usual that need to liner placement such as calcium hydroxide.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K03.1</hc_code>
      <hc_code>K03.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Abrasion of teeth</hc_keyword>
      <hc_keyword>Erosion of teeth</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Seventh Generation, One step, Optibond All-in-One (Kerr)</i_keyword>
      <i_keyword>Fifth Generation, Total-etch, two step, OptiBond Solo (Kerr)</i_keyword>
      <i_keyword>Fourth generation, total-etch, three steps, OptiBond FL(Kerr)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Color match. Timepoint: Baseline, 6 month, 12 month and 18 month after first appointment. Method of measurement: Visual inspection with mirror at 45 cm and periodic photography.</prim_outcome>
      <prim_outcome>Retention. Timepoint: Baseline, 6 months, 12 months and 18 months after intervention. Method of measurement: Visual inspection with explorer and mirror.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anatomic form. Timepoint: Baseline, 6 months, 12 months and 18 months after intervention. Method of measurement: Visual inspection with explorer and mirror, if needed.</sec_outcome>
      <sec_outcome>Caries formation. Timepoint: Baseline, 6 months, 12 months and 18 months after intervention. Method of measurement: Visual inspection with explorer, mirror, radiographies, if needed.</sec_outcome>
      <sec_outcome>Marginal adaptation. Timepoint: Baseline, 6 months, 12 months and 18 months after intervention. Method of measurement: Visual inspection with explorer and mirror, if needed.</sec_outcome>
      <sec_outcome>Marginal discoloration. Timepoint: Baseline, 6 months, 12 months and 18 months after intervention. Method of measurement: Visual inspection with mirror at 45 cm.</sec_outcome>
      <sec_outcome>Postoperative sensitivity. Timepoint: Baseline, 6 months, 12 months and 18 months after intervention. Method of measurement: Questioning the patients.</sec_outcome>
      <sec_outcome>Surface roughness. Timepoint: Baseline, 6 months, 12 months and 18 months after intervention. Method of measurement: Visual inspection with explorer and mirror.</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>Vice-chancellor for Research, Mashhad and Tabriz Universities of Medical Sciences.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2008-11-06</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Official Center of Mashhad university of Medical Sciences , University street. Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
