<?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>IRCT2016052628092N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-10-31</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of nano hydroxyapatites serum on reduction of enamel staining after orthodontic debonding with two different finishing, polishing techniques.</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of nano hydroxyapatites serum and two different finishing, polishing techniques on reduction of enamel staining after orthodontic debonding in comprehensive orthodontic patients; a randomized clinical trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-07-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22866</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>3</phase>
      <hc_freetext>Effect of nano hydroxyapatites serum on reduction of enamel staining after orthodontic debonding with two different finishing, polishing techniques..</hc_freetext>
      <i_freetext>Intervention 1: At the end of the fixed orthodontic treatment, brackets will be detached using a hand plier by gently squeezing the mesial and distal wings together. Removal of remnant resin will be done on all teeth by means of using carbide burs operated with low speed and water cooling used for 20 seconds. Then, randomly on one side of the mouth (Intervention group), carbide burs, followed by aluminum oxide discs (SofLex), will be used on the upper and lower premolars for finishing procedure. Randomization will be done by coin tossing. Then a rubber cup will be used in order to polish all teeth. All procedures will be performed by a single clinician and a new bur and rubber cup and disc will be used for each patient. To ensure complete resin removal, teeth will be evaluated under dental operating light with dental explorer. For all patients, the Nano Hydroxyapatite (Nano HAP) serum will be applied on the upper left and right first and second premolars (Intervention group), and the color alterations will be compared with lower left and right first and second premolars. Instruction for application of Nano HAP serum is as follows: a high concentration Nano HAP serum will be applied by the clinician on the teeth surface daily for 10 days, with a sponge on the head of the Nano HAP tubes for 2 to 3 minutes, and rinsed after 20 minutes with water. During the application of the solution, the teeth will be isolated with cotton rolls, according to the manufacturer’s instructions. A timetable will be given to the patients to control oral hygiene at home. Intervention 2: At the end of the fixed orthodontic treatment, brackets will be detached using a hand plier by gently squeezing the mesial and distal wings together. On the other side of the mouth, (Control group) after removal of the remnant resin by means of carbide burs, SofLex discs will not be used, just a rubber cup will be used in order to polish teeth. All procedures will be performed by single clinician and a new bur and rubber cup will be used for each patient. To ensure complete resin removal, teeth will be evaluated under dental operating light with dental explorer. The Nano HAP serum will not be applied on the lower left and right first and second premolars (control group), and the color alterations will be compared with the upper left and right first and second premolars. In order to optimize the results, the incisal third of the buccal surface of central incisors which is not affected by bonding and debonding procedures, is considered as the negative control group and will be evaluated by spectrophotometry analysis like other groups.</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>Behnam Malekpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Postcode: 71345-1836, Shiraz Dental School, Ghom abad, Ghasrodasht street, Shiraz, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71345-1836</zip>
        <telephone>+98 71 3227 6580</telephone>
        <email>malekpour.b@gmail.com</email>
        <affiliation>School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shabnam Ajami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Postcode: 71345-1836, Shiraz Dental School, Ghom abad, Ghasrodasht street, Shiraz, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 917 314 3440</telephone>
        <email>dr.ajami.sh@gmail.com</email>
        <affiliation>School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: adult patients (18 to 25 years old); patients with good compliance for this trial; permanent dentition; no plaque accumulation; Gingival and Plaque Index of 0 to 1; absence of dental caries and decalcifications in the teeth under examination; no smoking habit; non extraction orthodontic treatment. Exclusion criteria: patients with poor compliance; patients that had extraction in their orthodontic treatment; smokers; presence of caries or decalcifications in the teeth under examination; primary or mixed dentition; plaque accumulation; Gingival and Plaque Index more than 1.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>25 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>k03.7</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Posteruptive colour changes of dental hard tissues</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>At the end of the fixed orthodontic treatment, brackets will be detached using a hand plier by gently squeezing the mesial and distal wings together. Removal of remnant resin will be done on all teeth by means of using carbide burs operated with low speed and water cooling used for 20 seconds. Then, randomly on one side of the mouth (Intervention group), carbide burs, followed by aluminum oxide discs (SofLex), will be used on the upper and lower premolars for finishing procedure. Randomization will be done by coin tossing. Then a rubber cup will be used in order to polish all teeth. All procedures will be performed by a single clinician and a new bur and rubber cup and disc will be used for each patient. To ensure complete resin removal, teeth will be evaluated under dental operating light with dental explorer. For all patients, the Nano Hydroxyapatite (Nano HAP) serum will be applied on the upper left and right first and second premolars (Intervention group), and the color alterations will be compared with lower left and right first and second premolars. Instruction for application of Nano HAP serum is as follows: a high concentration Nano HAP serum will be applied by the clinician on the teeth surface daily for 10 days, with a sponge on the head of the Nano HAP tubes for 2 to 3 minutes, and rinsed after 20 minutes with water. During the application of the solution, the teeth will be isolated with cotton rolls, according to the manufacturer’s instructions. A timetable will be given to the patients to control oral hygiene at home.</i_keyword>
      <i_keyword>At the end of the fixed orthodontic treatment, brackets will be detached using a hand plier by gently squeezing the mesial and distal wings together. On the other side of the mouth, (Control group) after removal of the remnant resin by means of carbide burs, SofLex discs will not be used, just a rubber cup will be used in order to polish teeth. All procedures will be performed by single clinician and a new bur and rubber cup will be used for each patient. To ensure complete resin removal, teeth will be evaluated under dental operating light with dental explorer. The Nano HAP serum will not be applied on the lower left and right first and second premolars (control group), and the color alterations will be compared with the upper left and right first and second premolars. In order to optimize the results, the incisal third of the buccal surface of central incisors which is not affected by bonding and debonding procedures, is considered as the negative control group and will be evaluated by spectrophotometry analysis like other groups.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Enamel staining. Timepoint: Before intervention, 2 months after intervention, 4 months after intervention. Method of measurement: Measurement of tooth color parameters.</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>2017-07-09</approval_date>
        <contact_name>Shiraz University of Medical Sciences</contact_name>
        <contact_address>Postcode: 71345-1978, Central building of Shiraz University of Medical Sciences, Zand street, Shiraz, Iran Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
