<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03789812</url>
  </required_header>
  <id_info>
    <org_study_id>REU/Proposal2018</org_study_id>
    <nct_id>NCT03789812</nct_id>
  </id_info>
  <brief_title>Oral Hygiene in Patients With Orthodontic Fixed Appliances</brief_title>
  <official_title>Efficacy of Different Methods of Teeth Cleaning on Oral Hygiene in Patients With Orthodontic Fixed Appliances</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Riyadh Colleges of Dentistry and Pharmacy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Riyadh Colleges of Dentistry and Pharmacy</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to compare the efficacy of the use of different methods of teeth cleaning on&#xD;
      the oral hygiene in patients with orthodontic fixed appliance&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects were randomized into four groups, the first group will receive manual tooth brush&#xD;
      with super floss, the second group will receive electric tooth brush with super floss, the&#xD;
      third group will receive manual tooth brush with water dental flosser and the fourth group&#xD;
      will receive electric tooth brush with water flosser.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 3, 2018</start_date>
  <completion_date type="Anticipated">July 15, 2019</completion_date>
  <primary_completion_date type="Anticipated">May 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in plaque index</measure>
    <time_frame>baseline, after 4 weeks and after 8 weeks</time_frame>
    <description>plaque index: 0 no plaque, 1 plaque seen only on tip of explorer or with disclosing agents, 2 plaque seen with naked eye, 3 abundance of plaque</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in gingival index</measure>
    <time_frame>baseline, after 4 weeks and after 8 weeks</time_frame>
    <description>gingival index: 0, normal gingiva, 1 mild inflammation- slight change in color, slight edema and bleeding on probing. 2 moderate inflammation - redness, edema and bleeding on probing. 3, sever inflammation - redness, edema, and tendency to spontaneous bleeding</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Oral Hygiene</condition>
  <arm_group>
    <arm_group_label>Manual Toothbrush with Superfloss</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this group will receive Manual Toothbrush (Oral B) and Superfloss (Oral B) and will be instructed to use them three times a day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Electric Toothbrush with Superfloss</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group will receive Electric Toothbrush (JETPIK) and Superfloss (Oral B) and will be instructed to use them three times a day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Manual Toothbrush with Water Flosser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient in this group will receive Manual Toothbrush and Dental Water Jet and will be instructed to use them three times a day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Electric Toothbrush with Water Flosser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient in this group will receive Electric tooth brush (JETPIK) and water flosser and will be instructed to use them three times a day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Manual toothbrush</intervention_name>
    <description>Soft manual toothbrush (Oral B) will be used to brush occlusal, buccal and lingual teeth surfaces.</description>
    <arm_group_label>Manual Toothbrush with Superfloss</arm_group_label>
    <arm_group_label>Manual Toothbrush with Water Flosser</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electric Toothbrush</intervention_name>
    <description>Electric toothbrush (Jetpik JP210) will be used to brush occlusal, buccal and lingual teeth surfaces.</description>
    <arm_group_label>Electric Toothbrush with Superfloss</arm_group_label>
    <arm_group_label>Electric Toothbrush with Water Flosser</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Superfloss</intervention_name>
    <description>Superfloss (Oral B) will be used to clean interproximal teeth surfaces.</description>
    <arm_group_label>Electric Toothbrush with Superfloss</arm_group_label>
    <arm_group_label>Manual Toothbrush with Superfloss</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dental Water Jet</intervention_name>
    <description>Dental water jet (Jetpik JP210) will be used to clean interproximal teeth surfaces.</description>
    <arm_group_label>Electric Toothbrush with Water Flosser</arm_group_label>
    <arm_group_label>Manual Toothbrush with Water Flosser</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. participants with fixed orthodontic appliance.&#xD;
&#xD;
          2. participants age 14 years and above and didn't have mental of physical disabilities.&#xD;
&#xD;
          3. participants willing to comply with given oral hygiene instructions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. patients with mental retardation.&#xD;
&#xD;
          2. patients with systematic diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Omar H Alkadhi</last_name>
    <phone>966505154754</phone>
    <email>omar.alkadhi@riyadh.edu.sa</email>
  </overall_contact>
  <location>
    <facility>
      <name>Omar AlKadhi</name>
      <address>
        <city>Riyadh</city>
        <zip>11372</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Omar AlKadhi, BDS, MS</last_name>
      <phone>505154754</phone>
      <email>omar.alkadhi@riyadh.edu.sa</email>
    </contact>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>December 27, 2018</last_update_submitted>
  <last_update_submitted_qc>December 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Riyadh Colleges of Dentistry and Pharmacy</investigator_affiliation>
    <investigator_full_name>Omar Alkadhi</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03789812
org study id: REU/Proposal2018
nct id: NCT03789812
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study aims to compare the efficacy of the use of different methods of teeth cleaning on
      the oral hygiene in patients with orthodontic fixed appliance
Subjects were randomized into four groups, the first group will receive manual tooth brush
      with super floss, the second group will receive electric tooth brush with super floss, the
      third group will receive manual tooth brush with water dental flosser and the fourth group
      will receive electric tooth brush with water flosser.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Change in plaque index
time frame: baseline, after 4 weeks and after 8 weeks
description: plaque index: 0 no plaque, 1 plaque seen only on tip of explorer or with disclosing agents, 2 plaque seen with naked eye, 3 abundance of plaque
measure: Change in gingival index
time frame: baseline, after 4 weeks and after 8 weeks
description: gingival index: 0, normal gingiva, 1 mild inflammation- slight change in color, slight edema and bleeding on probing. 2 moderate inflammation - redness, edema and bleeding on probing. 3, sever inflammation - redness, edema, and tendency to spontaneous bleeding
arm group label: Manual Toothbrush with Superfloss
arm group type: Active Comparator
description: Patients in this group will receive Manual Toothbrush (Oral B) and Superfloss (Oral B) and will be instructed to use them three times a day.
arm group label: Electric Toothbrush with Superfloss
arm group type: Experimental
description: Patients in this group will receive Electric Toothbrush (JETPIK) and Superfloss (Oral B) and will be instructed to use them three times a day.
arm group label: Manual Toothbrush with Water Flosser
arm group type: Experimental
description: Patient in this group will receive Manual Toothbrush and Dental Water Jet and will be instructed to use them three times a day.
arm group label: Electric Toothbrush with Water Flosser
arm group type: Experimental
description: Patient in this group will receive Electric tooth brush (JETPIK) and water flosser and will be instructed to use them three times a day.
intervention type: Device
intervention name: Manual toothbrush
description: Soft manual toothbrush (Oral B) will be used to brush occlusal, buccal and lingual teeth surfaces.
arm group label: Manual Toothbrush with Superfloss
arm group label: Manual Toothbrush with Water Flosser
intervention type: Device
intervention name: Electric Toothbrush
description: Electric toothbrush (Jetpik JP210) will be used to brush occlusal, buccal and lingual teeth surfaces.
arm group label: Electric Toothbrush with Superfloss
arm group label: Electric Toothbrush with Water Flosser
intervention type: Device
intervention name: Superfloss
description: Superfloss (Oral B) will be used to clean interproximal teeth surfaces.
arm group label: Electric Toothbrush with Superfloss
arm group label: Manual Toothbrush with Superfloss
intervention type: Device
intervention name: Dental Water Jet
description: Dental water jet (Jetpik JP210) will be used to clean interproximal teeth surfaces.
arm group label: Electric Toothbrush with Water Flosser
arm group label: Manual Toothbrush with Water Flosser
criteria: 
gender: All
minimum age: 14 Years
maximum age: 50 Years
healthy volunteers: No
last name: Omar H Alkadhi
phone: 966505154754
email: omar.alkadhi@riyadh.edu.sa
facility: 
status: Recruiting
contact: 
country: Saudi Arabia
responsible party type: Principal Investigator
investigator affiliation: Riyadh Colleges of Dentistry and Pharmacy
investigator full name: Omar Alkadhi
investigator title: Assistant professor
sharing ipd: No