<?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>IRCT20200215046505N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-09</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of subgingival irrigation with Chamomile on periodontal disease</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the clinical effect of subgingival irrigation with chamomile, Persica and chlorhexidine on periodontal disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>11</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46744</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: The participants on the research didnt know which irrigation material used,by white labels which hiding names of the viaاs containing.</study_design>
      <phase>3</phase>
      <hc_freetext>periodontitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Immediately after scaling, each quadrant went under one of the subgingival irrigation with one of the mentioned materials, randomly. First groups material was Chammomile extract.We placed 40 grams of chamomile flower powder with herbarium code (PM 407) in a paper filter and was  Soxhlet extractor (AshkeShishe Co., Iran) solved it in 1 liter of distilled water for 4 hours. 100 cc of it was freez- dried. At first the percent of dried material was calculated about 8 percent and then the liquid extract was used in the study. These process was repeated every week to make sure that the property was maintained. Irrigation was done by dull insulin syringes which were marked 2mm  by a Williams probe. The syringe was placed 2mm under the gingival margin and the volume of the mouth rinse   was proportionate to pocket depth as the  liquid poured out the  pocket. Suction was placed in the mouth in whole time of the irrigation. First irrigation was done immediately after the scaling and it was repeated two more times in 48-hour intervals. Patients were recommended not to eat or drink for two hours after the irrigation. The interval between the last teeth brushing and irrigation was considered at least 30 minutes. Intervention 2: Intervention group:Immediately after scaling, each quadrant went under one of the subgingival irrigation with one of the mentioned materials, randomly.Second group was chlorhexidine 0.2 %  (Behsa Pharmaceutical Co., Iran).Irrigation was done by dull insulin syringes which were marked 2mm  by a Williams probe. The syringe was placed 2mm under the gingival margin and the volume of the mouth rinse   was proportionate to pocket depth as the  liquid poured out the  pocket. Suction was placed in the mouth in whole time of the irrigation. First irrigation was done immediately after the scaling and it was repeated two more times in 48-hour intervals. Patients were recommended not to eat or drink for two hours after the irrigation. The interval between the last teeth brushing and irrigation was considered at least 30 minutes. Intervention 3: Intervention group: Immediately after scaling, each quadrant went under one of the subgingival irrigation with one of the mentioned materials, randomly.Third group was persica (Poursina Pharmaceutical Co., Iran).Irrigation was done by dull insulin syringes which were marked 2mm  by a Williams probe. The syringe was placed 2mm under the gingival margin and the volume of the mouth rinse   was proportionate to pocket depth as the  liquid poured out the  pocket. Suction was placed in the mouth in whole time of the irrigation. First irrigation was done immediately after the scaling and it was repeated two more times in 48-hour intervals. Patients were recommended not to eat or drink for two hours after the irrigation. The interval between the last teeth brushing and irrigation was considered at least 30 minutes. Intervention 4: Control group:  Immediately after scaling, each quadrant went under one of the subgingival irrigation with one of the mentioned materials, randomly.Third group was normal saline.Irrigation was done by dull insulin syringes which were marked 2mm  by a Williams probe. The syringe was placed 2mm under the gingival margin and the volume of the mouth rinse   was proportionate to pocket depth as the  liquid poured out the  pocket. Suction was placed in the mouth in whole time of the irrigation. First irrigation was done immediately after the scaling and it was repeated two more times in 48-hour intervals. Patients were recommended not to eat or drink for two hours after the irrigation. The interval between the last teeth brushing and irrigation was considered at least 30 minutes.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Emami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz Dental School, Ghasrodasht Ave., Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7195615878</zip>
        <telephone>+98 71 3626 3193</telephone>
        <email>zahra_emami63@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Emami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz Dental School, Ghasrodasht Ave., Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7195615878</zip>
        <telephone>+98 71 3626 3193</telephone>
        <email>zahra_emami63@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with moderate to severe chronic periodontitis which has over 3 millimeters attachment loss
Having at least 20 teeth
Existence of at least a pocket depth of 5 millimeters or more in posterior teeth in each quadrant
Slow rate of disease progression without familial aggregation
Without any history of systemic disease
Volunteers whom was referred to periodontology department of Shiraz school of dentistry</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any sub gingival crown or filling on the desired area
History of allergy to chamomile
Need for antibiotic prophylaxis
History of any periodontal treatment and SRP in last 3 months
Pregnancy
Smokers
Medical conditions which interfere with dental treatments</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K05.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Periodontal disease, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Immediately after scaling, each quadrant went under one of the subgingival irrigation with one of the mentioned materials, randomly. First groups material was Chammomile extract.We placed 40 grams of chamomile flower powder with herbarium code (PM 407) in a paper filter and was  Soxhlet extractor (AshkeShishe Co., Iran) solved it in 1 liter of distilled water for 4 hours. 100 cc of it was freez- dried. At first the percent of dried material was calculated about 8 percent and then the liquid extract was used in the study. These process was repeated every week to make sure that the property was maintained. Irrigation was done by dull insulin syringes which were marked 2mm  by a Williams probe. The syringe was placed 2mm under the gingival margin and the volume of the mouth rinse   was proportionate to pocket depth as the  liquid poured out the  pocket. Suction was placed in the mouth in whole time of the irrigation. First irrigation was done immediately after the scaling and it was repeated two more times in 48-hour intervals. Patients were recommended not to eat or drink for two hours after the irrigation. The interval between the last teeth brushing and irrigation was considered at least 30 minutes.</i_keyword>
      <i_keyword>Intervention group:Immediately after scaling, each quadrant went under one of the subgingival irrigation with one of the mentioned materials, randomly.Second group was chlorhexidine 0.2 %  (Behsa Pharmaceutical Co., Iran).Irrigation was done by dull insulin syringes which were marked 2mm  by a Williams probe. The syringe was placed 2mm under the gingival margin and the volume of the mouth rinse   was proportionate to pocket depth as the  liquid poured out the  pocket. Suction was placed in the mouth in whole time of the irrigation. First irrigation was done immediately after the scaling and it was repeated two more times in 48-hour intervals. Patients were recommended not to eat or drink for two hours after the irrigation. The interval between the last teeth brushing and irrigation was considered at least 30 minutes.</i_keyword>
      <i_keyword>Intervention group: Immediately after scaling, each quadrant went under one of the subgingival irrigation with one of the mentioned materials, randomly.Third group was persica (Poursina Pharmaceutical Co., Iran).Irrigation was done by dull insulin syringes which were marked 2mm  by a Williams probe. The syringe was placed 2mm under the gingival margin and the volume of the mouth rinse   was proportionate to pocket depth as the  liquid poured out the  pocket. Suction was placed in the mouth in whole time of the irrigation. First irrigation was done immediately after the scaling and it was repeated two more times in 48-hour intervals. Patients were recommended not to eat or drink for two hours after the irrigation. The interval between the last teeth brushing and irrigation was considered at least 30 minutes.</i_keyword>
      <i_keyword>Control group:  Immediately after scaling, each quadrant went under one of the subgingival irrigation with one of the mentioned materials, randomly.Third group was normal saline.Irrigation was done by dull insulin syringes which were marked 2mm  by a Williams probe. The syringe was placed 2mm under the gingival margin and the volume of the mouth rinse   was proportionate to pocket depth as the  liquid poured out the  pocket. Suction was placed in the mouth in whole time of the irrigation. First irrigation was done immediately after the scaling and it was repeated two more times in 48-hour intervals. Patients were recommended not to eat or drink for two hours after the irrigation. The interval between the last teeth brushing and irrigation was considered at least 30 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The rate of periodontal pocket depth. Timepoint: before intervention and 4 weeks after intervention. Method of measurement: periodontal probe.</prim_outcome>
      <prim_outcome>The rate of bleeding on probing. Timepoint: before intervention and 4 weeks after intervention. Method of measurement: periodontal probe.</prim_outcome>
      <prim_outcome>The rate of dental plaque. Timepoint: before intervention and 4 weeks after intervention. Method of measurement: Disclosing agent.</prim_outcome>
      <prim_outcome>Gingival recession rate. Timepoint: before intervention and 4 weeks after intervention. Method of measurement: periodontal probe.</prim_outcome>
      <prim_outcome>Mucogingival junction. Timepoint: before intervention and 4 weeks after intervention. Method of measurement: periodontal probe.</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>2015-12-15</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Shiraz dental school, Ghasrodasht Ave., Shiraz Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
