<?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>IRCT20210212050332N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-16</date_registration>
      <primary_sponsor>Riphah International University  (RARE)</primary_sponsor>
      <public_title>Effect on coconut oil, moringaoleifera and chlorhexidine on oral health.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of antimicrobial properties of coconut oil, moringa oleifera and chlorhexidine on oral bacterial populations</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54269</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>1</phase>
      <hc_freetext>Condition 1: Caries. Condition 2: Periodontitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: (Coconut oil). 30 individuals in this group will be sampled from the sub gingival area  of the lingual surfaces of lower central incisors. The plaque and gingival crevicular fluid collected will be sent for detailed microbiologic analysis (PCR, biochemical testing, bacterial culture). All individuals will be given an emulsion of non-hydrogenated coconut oil as a mouthwash. The participant will be requested to rinse with 15 mL emulsion twice daily. On day 14, the participant will be undergo microbiologic analysis again from the same site. Intervention 2: Intervention group: (Moringa Oleifera). 30 individuals in this group will be sampled from the sub gingival area  of the lingual surfaces of lower central incisors. The plaque and gingival crevicular fluid collected will be sent for detailed microbiologic analysis (PCR, biochemical testing, bacterial culture). All individuals will be given a mouthwash made with moringa oleifera extract. The participant will be requested to rinse with 15 mL solution twice daily. On day 14, the participant will be undergo microbiologic analysis again from the same site. Intervention 3: Control group: (Chlorhexidine gluconate). Chlorhexidine gluconate is a gold standard antibacterial for the oral cavity. This is why it will be used in the control group to compare the efficacy of gold standard against the coconut oil and moringa oleifera mouthwashes. 30 individuals in this group will be sampled from the sub gingival area  of the lingual surfaces of lower central incisors. The plaque and gingival crevicular fluid collected will be sent for detailed microbiologic analysis (PCR, biochemical testing, bacterial culture). All individuals will be given a 0.2% chlorhexidine. The participant will be requested to rinse with 15 mL solution twice daily. On day 14, the participant will be undergo microbiologic analysis again from the same site.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All collected deidentified IPD will be submitted.

When:
The data will be made available following completion of the project for a 4 week period.

To whom:
Data sharing will be open to all.

Conditions:
The primary investigator will decide on who to release data to.

Where to obtain:
Email requests will be accommodated.

How to obtain:
An email request needs to be sent to the principal investigator.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amber Kiyani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>7th Avenue, G-7/4</address>
        <city>Islamabad</city>
        <country1>Pakistan</country1>
        <zip>44000</zip>
        <telephone>+92 51 2891835</telephone>
        <email>akiyani@gmail.com</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amber Kiyani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Riphah International University, 7th Avenue, G-7/4</address>
        <city>Islamabad</city>
        <country1>Pakistan</country1>
        <zip>44000</zip>
        <telephone>+92 51 2891835</telephone>
        <email>akiyani@gmail.com</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Good oral hygiene.
Good brushing habits.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Periodontal disease.
Systemic disease affecting periodontal health.
Recent history of oral prophylaxis.
Recent history of antibiotic use.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K02.9</hc_code>
      <hc_code>K05.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dental caries, unspecified</hc_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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: (Coconut oil). 30 individuals in this group will be sampled from the sub gingival area  of the lingual surfaces of lower central incisors. The plaque and gingival crevicular fluid collected will be sent for detailed microbiologic analysis (PCR, biochemical testing, bacterial culture). All individuals will be given an emulsion of non-hydrogenated coconut oil as a mouthwash. The participant will be requested to rinse with 15 mL emulsion twice daily. On day 14, the participant will be undergo microbiologic analysis again from the same site.</i_keyword>
      <i_keyword>Intervention group: (Moringa Oleifera). 30 individuals in this group will be sampled from the sub gingival area  of the lingual surfaces of lower central incisors. The plaque and gingival crevicular fluid collected will be sent for detailed microbiologic analysis (PCR, biochemical testing, bacterial culture). All individuals will be given a mouthwash made with moringa oleifera extract. The participant will be requested to rinse with 15 mL solution twice daily. On day 14, the participant will be undergo microbiologic analysis again from the same site.</i_keyword>
      <i_keyword>Control group: (Chlorhexidine gluconate). Chlorhexidine gluconate is a gold standard antibacterial for the oral cavity. This is why it will be used in the control group to compare the efficacy of gold standard against the coconut oil and moringa oleifera mouthwashes. 30 individuals in this group will be sampled from the sub gingival area  of the lingual surfaces of lower central incisors. The plaque and gingival crevicular fluid collected will be sent for detailed microbiologic analysis (PCR, biochemical testing, bacterial culture). All individuals will be given a 0.2% chlorhexidine. The participant will be requested to rinse with 15 mL solution twice daily. On day 14, the participant will be undergo microbiologic analysis again from the same site.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Oral microbial populations. Timepoint: 2 weeks. Method of measurement: Culture, PCR, biochemical methods.</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>Riphah International University  (RARE)</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-06</approval_date>
        <contact_name>Institutional Review Committee, Riphah International University</contact_name>
        <contact_address>Riphah International University, Islamic International Dental College, 7th Avenue, G-7/4 Islamabad Federal Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
