<?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>IRCT20231123060153N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-07-21</date_registration>
      <primary_sponsor>Gorgan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of flossing and brushing on plaque and gingival index</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of effect of using dental floss before and after brushing on  plaque index and gingival index of posterior teeth in dental students of Gorgan dental faculty</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75332</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Health service research, Other design features: In this study, referring to Turkezban et al.'s study (11) with a confidence level of 0.95 and a test power of 0.80, and taking into account the purpose of comparing the average plaque index before and after using the following formula, a total of 32 people were randomly sampled. students will be selected from the community under study. The students will be assigned to two groups by block allocation, the first group will use toothbrush-dental floss for two weeks and the second group will use dental floss-brush and after two weeks, its plaque index and gingival index will be measured. and two weeks of wash out will be taken into account and after that their plaque index and gingival index will be measured and again the students of the first group will first use dental floss-brush and the second group will use toothbrush-floss and after two weeks the plaque index And the gingival index will be measured, Randomization description: Block randomization of study groups:
In the first stage, people are randomly divided into toothbrush-dental floss (A) and dental floss-toothbrush (B) groups. Random block method will be used to assign people to groups. For this purpose, all six positions of letters A and B are considered in blocks of four.
                             Table 1: Table 1: Generated random block
                                                 (1) AABB
                                                 (2)BBAA
                                                 (3)ABAB
                                                 (4)BABA
                                                 (5)ABBA  
                                                 (6)BAAB
To allocate 16 students in each group (32 people in total), 8 blocks of 4 are needed. To select 8 blocks first, 8 random numbers between 1 and 6 will be generated by repetition (with placement). Thus, a sequence of letters A and B will be created containing 32 letters (16 letters A and 16 letters B).
The random numbers generated in the R software and the random block attributed to the numbers generated using the above table are as follows

Block number       Randomly generated number              Attributed block    

1                            4                                                                  BABA
2                            5                                                                  ABBA
3                            6                                                                  BAAB
4                            6                                                                  BAAB
5                            1                                                                  AABB
6                            2                                                                  BBAA
7                            4                                                                   BABA
8                            3                                                                   ABAB

For example, the first person who meets the study entry criteria is in group B, the second person is in group A, the third person is in group B, and the fourth person is in group A. And it continues until 32 people respectively. People are matched in terms of age and sex, Blinding description: The examiners are not aware of the type of intervention (single blind).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Gingival Index, Plaque Index.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: using a toothbrush after using dental floss. Intervention 2: Control group: using dental floss after using a toothbrush.</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:
The documents will be attached to the file.

When:
The access period starts from 1402

To whom:
Everyone can access the documents.

Conditions:
If the requesters need, the data will be sent to them.

Where to obtain:
By sending an email to the responsible author, the data will be sent to the requester.

How to obtain:
By sending an email to the responsible author, the data will be sent to the requester.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amir reza Ahmadinia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasar street</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4916648679</zip>
        <telephone>+98 17 3253 6270</telephone>
        <email>ar.ahmadinia@gmail.com</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir reza Ahmadinia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasar street</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4916648679</zip>
        <telephone>+98 17 3253 6270</telephone>
        <email>ar.ahmadinia@gmail.com</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Physically and mentally healthy people
Having all posterior permanent teeth except wisdom teeth
People aged between 20 and 40 years</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>People with orthodontic appliances
People without interdental contact
Crowding and malposition of posterior teeth
People with periodontal disease
Active caries or extensive restorations or crown of posterior teeth
Having a systemic disease affecting the periodontal tissue
Taking medications that affect periodontal tissue
Consumption of alcohol and cigarettes
Pregnancy and lactating
Taking antibiotics in the last three months for one week.</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>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: using a toothbrush after using dental floss</i_keyword>
      <i_keyword>Control group: using dental floss after using a toothbrush</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Gingival Index، Plaqe Index. Timepoint: Before starting the intervention in both groups، Two weeks after intervention in each group, two weeks after cleansing, two weeks after intervention. Method of measurement: For the gingival index variable, we first measured the four surfaces of the teeth with the help of a probe and if 0: normal gums, 1: mild inflammation, slight color change, no swelling, no BOP2: moderate inflammation, redness, swelling and glossiness of the gums with BOP3: severe inflammation with Redness and swelling, wounds and continuous bleeding, and for the index plaque variable from Fuchsin tablets, which is based on the amount of tooth surface color using the following formula (number of teeth)/(teeth 100 (percentage) x 4).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Gingival Index ، Plaqe Index. Timepoint: Before starting the intervention in both groups، Two weeks after intervention in each group, two weeks after cleansing, two weeks after intervention. Method of measurement: For the gingival index variable, we first measured the four surfaces of the teeth with the help of a probe and if 0: normal gums, 1: mild inflammation, slight color change, no swelling, no BOP2: moderate inflammation, redness, swelling and glossiness of the gums with BOP3: severe inflammation with Redness and swelling, wounds and continuous bleeding, and for the index plaque variable from Fuchsin tablets, which is based on the amount of tooth surface color using the following formula (number of teeth) devided (teeth 100 (percentage) x 4).</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>Gorgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-03</approval_date>
        <contact_name>Ethics committee of Golestan University of Medical Sciences</contact_name>
        <contact_address>Gorgan, Shahrek Shahryar, Shahryar 5, Gorgan Faculty of Dentistry Gorgan Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
