<?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>IRCT2016102630475N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-02-09</date_registration>
      <primary_sponsor>Vice chancellor for research, Dentistry faculty, Tehran University Of Medical Sciences</primary_sponsor>
      <public_title>The effect of the propolis in oral wound healing</public_title>
      <acronym>-</acronym>
      <scientific_title>Clinical trial of comparison the effect of the propolis extract in combination with dressing without eugenol (Coe-Packtm) and Coe Packtm dressing in wound healing among patients undergoing crown lengthening surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24204</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>-.</hc_freetext>
      <i_freetext>Intervention 1: Control group: The patients washed their mouth before surgery with chlorhexidine 0.12% for 30 seconds. Lidocaine 2% with epinephrine 1:100000 (Septodont, France) were prescribed for local anesthesia, too. After pulling over the flap and bringing out the granulation tissue, osteotomy with 13K/TG krikland periodontal chisel (Hu-Friedy Dental Instruments ,Chicago, USA), carbide burs (JOTA AG Rotary Instruments, Ruthi, Switzerland) under irrigation with saline solution until obtaining a distance of 3mm from bone crest to the most cervical portion of the cavity that was measured with a Williams periodontal probe (Neumar®). At the end of the procedure, a simple suture was performed with some silk thread (Supa, Iran). Time duration from the first cut to the last stitch for all the patients has been between 90–115 minutes. After surgery, the patients were divided into two randomized groups. In control group, the dressing was mixed with sterile spatula on a sterile glass plate according to the manufacturer’s instruction. Dressing was formed on the wound to adjust moderately. All the patients were educated to control the plaque with chlorhexidine 0.12% every 12 hours during 7 days and Ibuprofen 400 mg was prescribed every 6 hours, if necessary. Number and time of beginning the paregoric was recorded, too. All the patients received written and oral postoperative instructions. Some objective and subjective criteria were used to study the healing process. Intervention 2: Intervention group: The patients washed their mouth before surgery with chlorhexidine 0.12% for 30 seconds. Lidocaine 2% with epinephrine 1:100000 (Septodont, France) were prescribed for local anesthesia, too. After pulling over the flap and bringing out the granulation tissue, osteotomy with 13K/TG krikland periodontal chisel (Hu-Friedy Dental Instruments ,Chicago, USA), carbide burs (JOTA AG Rotary Instruments, Ruthi, Switzerland) under irrigation with saline solution until obtaining a distance of 3mm from bone crest to the most cervical portion of the cavity that was measured with a Williams periodontal probe (Neumar®). At the end of the procedure, a simple suture was performed with some silk thread (Supa, Iran). Time duration from the first cut to the last stitch for all the patients has been between 90–115 minutes. After surgery, the patients were divided into two randomized groups. After surgery, the patients were divided in two randomized groups. In trial group propolis extract was combined with coe-packtm. Then the dressing was mixed with sterile spatula on a sterile glass plate according to the manufacturer’s instruction. Dressing was formed on the wound to adjust moderately. Dressing in trial group was as the same as control group except adding 0.1 mm of 20% propolis hydroalcoholic solution (soren Tech Toos, Mashhad, Iran) per every 5 mm of dressing paste to the final dressing composition and placing that on the wound. This amount of propolis extract didn’t have any impact on the final dressing formidability. All the patients were educated to control the plaque with chlorhexidine 0.12% every 12 hours during 7 days and Ibuprofen 400 mg was prescribed every 6 hours, if necessary. Number and time of beginning the paregoric was recorded, too. All the patients received the written and oral postoperative instructions. Some objective and subjective criteria was used for studying the healing process.</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>Atena Beiky</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dentistry faculty Of Tehran University Of Medical Sciences, Mahan St., Navab Blv.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 5585 1131</telephone>
        <email>Atena. beiki69@gmail.com</email>
        <affiliation>Dentistry faculty, Tehran University Of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mitra Askari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department Of Pathology, Dentistry Faculty, Tehran University Of Medicine  Sciences, North Amir Abad St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 5585 1131</telephone>
        <email>Askari_mitra@ymail.com</email>
        <affiliation>Dentistry Faculty, Tehran University Of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: bone removal scale in their surgery was between 1-2 mm; their surgical time duration lasted between 90-115 minutes and had been used from both of chisels and bur in their surgery; don’t have any systematically problem; no periodontal disease in the surgical site; no restriction on surgery; don’t need to the antibiotic prophylaxis during the surgery; don’t use the corticosteroids or hormone in the last 2 months.&#13;
Exclusion criteria:  when there is a problem in recording the patient’s information; smoking.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>-</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>-</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: The patients washed their mouth before surgery with chlorhexidine 0.12% for 30 seconds. Lidocaine 2% with epinephrine 1:100000 (Septodont, France) were prescribed for local anesthesia, too. After pulling over the flap and bringing out the granulation tissue, osteotomy with 13K/TG krikland periodontal chisel (Hu-Friedy Dental Instruments ,Chicago, USA), carbide burs (JOTA AG Rotary Instruments, Ruthi, Switzerland) under irrigation with saline solution until obtaining a distance of 3mm from bone crest to the most cervical portion of the cavity that was measured with a Williams periodontal probe (Neumar®). At the end of the procedure, a simple suture was performed with some silk thread (Supa, Iran). Time duration from the first cut to the last stitch for all the patients has been between 90–115 minutes. After surgery, the patients were divided into two randomized groups. In control group, the dressing was mixed with sterile spatula on a sterile glass plate according to the manufacturer’s instruction. Dressing was formed on the wound to adjust moderately. All the patients were educated to control the plaque with chlorhexidine 0.12% every 12 hours during 7 days and Ibuprofen 400 mg was prescribed every 6 hours, if necessary. Number and time of beginning the paregoric was recorded, too. All the patients received written and oral postoperative instructions. Some objective and subjective criteria were used to study the healing process.</i_keyword>
      <i_keyword>Intervention group: The patients washed their mouth before surgery with chlorhexidine 0.12% for 30 seconds. Lidocaine 2% with epinephrine 1:100000 (Septodont, France) were prescribed for local anesthesia, too. After pulling over the flap and bringing out the granulation tissue, osteotomy with 13K/TG krikland periodontal chisel (Hu-Friedy Dental Instruments ,Chicago, USA), carbide burs (JOTA AG Rotary Instruments, Ruthi, Switzerland) under irrigation with saline solution until obtaining a distance of 3mm from bone crest to the most cervical portion of the cavity that was measured with a Williams periodontal probe (Neumar®). At the end of the procedure, a simple suture was performed with some silk thread (Supa, Iran). Time duration from the first cut to the last stitch for all the patients has been between 90–115 minutes. After surgery, the patients were divided into two randomized groups. After surgery, the patients were divided in two randomized groups. In trial group propolis extract was combined with coe-packtm. Then the dressing was mixed with sterile spatula on a sterile glass plate according to the manufacturer’s instruction. Dressing was formed on the wound to adjust moderately. Dressing in trial group was as the same as control group except adding 0.1 mm of 20% propolis hydroalcoholic solution (soren Tech Toos, Mashhad, Iran) per every 5 mm of dressing paste to the final dressing composition and placing that on the wound. This amount of propolis extract didn’t have any impact on the final dressing formidability. All the patients were educated to control the plaque with chlorhexidine 0.12% every 12 hours during 7 days and Ibuprofen 400 mg was prescribed every 6 hours, if necessary. Number and time of beginning the paregoric was recorded, too. All the patients received the written and oral postoperative instructions. Some objective and subjective criteria was used for studying the healing process.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: 0,1,2,3,4,5,6 and 7 days after surgery. Method of measurement: Visual Analog Scale.</prim_outcome>
      <prim_outcome>Burning sensation. Timepoint: 0, 1,2,3,4,5,6 and 7 days after surgery. Method of measurement: Visual Analog Scale.</prim_outcome>
      <prim_outcome>Consistency of gingiva. Timepoint: 7th day after surgery. Method of measurement: palpation with a blunt instrument.</prim_outcome>
      <prim_outcome>Colour compatibility. Timepoint: 7th day after surgery. Method of measurement: Visual Analog Scale.</prim_outcome>
      <prim_outcome>Infection. Timepoint: 2nd &amp; 7th days after surgery. Method of measurement: Clinical examination.</prim_outcome>
      <prim_outcome>Bleeding during probing. Timepoint: 7th day after surgery. Method of measurement: Probing.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>-. Timepoint: -. Method of measurement: -.</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, Dentistry faculty, Tehran University Of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-01-02</approval_date>
        <contact_name>Ethic Committee of  Tehran University of  Medical Science</contact_name>
        <contact_address>Ghods St., Keshavarz Blvd Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
