<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/NCT04456114</url>
  </required_header>
  <id_info>
    <org_study_id>IIDC/IRB/06/06/2020</org_study_id>
    <nct_id>NCT04456114</nct_id>
  </id_info>
  <brief_title>Micro-abrasive Blasting vs Acid Etching of Orthodontic Bracket Bases</brief_title>
  <official_title>Micro-abrasive Blasting vs Acid Etching of Orthodontic Bracket Bases: A Scanning Electron Microscope Study and an Eighteen Month Randomized Clinical Control</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Riphah International University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Riphah International University</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>
      To describe a method of acid etching the base of a bracket, and to compare the bond failures&#xD;
      between micro-abrasive blasted (sandblasted) brackets and acid etched brackets over an&#xD;
      eighteen month period&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aims of this randomized control trial are:&#xD;
&#xD;
        1. To describe a method to chemically etch the bases of stainless steel orthodontic&#xD;
           brackets.&#xD;
&#xD;
        2. To observe the changes in the micro-structure of the brackets with sandblasted bases and&#xD;
           acid-etched bases under an electron microscope.&#xD;
&#xD;
        3. To compare the failure of orthodontic brackets with a chemical etched base versus a&#xD;
           sandblasted base bonded with composite using the conventional acid etch technique, over&#xD;
           a follow-up of 18 months&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">January 31, 2020</completion_date>
  <primary_completion_date type="Actual">January 31, 2020</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>
    <intervention_model_description>parallel-group, split mouth, triple blinded, randomized control trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bond Failure Rate</measure>
    <time_frame>18 months after placement of brackets on the teeth</time_frame>
    <description>To compare the bond failure rates between acid etched and sandblasted brackets. Done by calculating and comparing the percentages of bracket breakages between the acid etched and sandblasted bracket quadrants.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">340</enrollment>
  <condition>Orthodontic Appliances</condition>
  <arm_group>
    <arm_group_label>Acid etched brackets</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stainless steel bracket base etched with 10% Hydrofluoric acid for 1 minute</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sandblasted brackets</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Stainless steel bracket sandblasted base</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Acid etched brackets</intervention_name>
    <description>The brackets will be bonded to the teeth with composite on the same patient in a split mouth design and observed for bracket debonding for 18 months</description>
    <arm_group_label>Acid etched brackets</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sandblasted brackets</intervention_name>
    <description>The brackets will be bonded to the teeth with composite on the same patient in a split mouth design and observed for bracket debonding for 18 months</description>
    <arm_group_label>Sandblasted brackets</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients about to undergo fixed orthodontic therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with cavities, history of fixed orthodontic therapy, recent bleaching&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Owais K Durrani, FFDRCSI</last_name>
    <role>Principal Investigator</role>
    <affiliation>Riphah International University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Islamic International Dental College</name>
      <address>
        <city>Islamabad</city>
        <zip>44000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>July 2, 2020</last_update_submitted>
  <last_update_submitted_qc>July 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Riphah International University</investigator_affiliation>
    <investigator_full_name>Owais Khalid Durrani</investigator_full_name>
    <investigator_title>Professor of Orthodonitcs</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/NCT04456114
org study id: IIDC/IRB/06/06/2020
nct id: NCT04456114
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To describe a method of acid etching the base of a bracket, and to compare the bond failures
      between micro-abrasive blasted (sandblasted) brackets and acid etched brackets over an
      eighteen month period
The aims of this randomized control trial are:

        1. To describe a method to chemically etch the bases of stainless steel orthodontic
           brackets.

        2. To observe the changes in the micro-structure of the brackets with sandblasted bases and
           acid-etched bases under an electron microscope.

        3. To compare the failure of orthodontic brackets with a chemical etched base versus a
           sandblasted base bonded with composite using the conventional acid etch technique, over
           a follow-up of 18 months
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: parallel-group, split mouth, triple blinded, randomized control trial
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Bond Failure Rate
time frame: 18 months after placement of brackets on the teeth
description: To compare the bond failure rates between acid etched and sandblasted brackets. Done by calculating and comparing the percentages of bracket breakages between the acid etched and sandblasted bracket quadrants.
arm group label: Acid etched brackets
arm group type: Experimental
description: Stainless steel bracket base etched with 10% Hydrofluoric acid for 1 minute
arm group label: Sandblasted brackets
arm group type: Active Comparator
description: Stainless steel bracket sandblasted base
intervention type: Device
intervention name: Acid etched brackets
description: The brackets will be bonded to the teeth with composite on the same patient in a split mouth design and observed for bracket debonding for 18 months
arm group label: Acid etched brackets
intervention type: Device
intervention name: Sandblasted brackets
description: The brackets will be bonded to the teeth with composite on the same patient in a split mouth design and observed for bracket debonding for 18 months
arm group label: Sandblasted brackets
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Owais K Durrani, FFDRCSI
role: Principal Investigator
affiliation: Riphah International University
facility: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Riphah International University
investigator full name: Owais Khalid Durrani
investigator title: Professor of Orthodonitcs
sharing ipd: No