xml: <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/NCT06010797</url>
    </required_header>
    <id_info>
      <org_study_id>RehmatMPGDTH</org_study_id>
      <nct_id>NCT06010797</nct_id>
    </id_info>
    <brief_title>Effect of Pre-treatment Photographs on Oral Hygiene Maintenance in Orthodontic Patients</brief_title>
    <official_title>Effect of Pre-treatment Photographs on Oral Hygiene Maintenance in Orthodontic Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Rehmat Memorial Post Graduate Dental Teaching Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Rehmat Memorial Post Graduate Dental Teaching Hospital</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>
        Dental photography is an essential component of orthodontic treatment. Photographs enable the&#xD;
        clinician to keep record of different stages of treatment. Other uses are for treatment&#xD;
        planning, communicating with the patients and other specialists, comparison of pre-treatment&#xD;
        and post-treatment changes, for research purpose and also for patient's motivation. Images&#xD;
        captured before, during and after treatment provide legal protection when necessary. In the&#xD;
        orthodontic discipline, at least three extra-oral and five intra-oral photographs are&#xD;
        recommended. Extra-oral photographs should correctly reflect patient's appearance and&#xD;
        intra-oral photographs should show complete dentition and occlusion.&#xD;
  &#xD;
        Oral hygiene is controlled by the patient during orthodontic treatment which requires proper&#xD;
        motivation. Motivational methods are classified as chair-side education, message reminders,&#xD;
        behavioral modification and Hawthorne effect. Patients' motivation plays an important role in&#xD;
        maintaining favorable oral hygiene. A number of studies have shown the effect of motivational&#xD;
        methods on oral hygiene improvement. In one of these studies, 80 patients who needed&#xD;
        orthodontic treatment were selected and randomly distributed into two equal groups as control&#xD;
        group and study group. The study group patients were included in a Whatsapp where they shared&#xD;
        their own photographs (selfies) and received text messages, while the control group patients&#xD;
        were not included in any Whatsapp group. Baseline PI scoring was 0.48(0.34) in control group&#xD;
        and 0.41(0.32) in study group, After 3 months PI scoring was 1.72(0.33) in control group and&#xD;
        1.68(0.40) in study group. Results showed that sharing of selfies improves oral hygiene&#xD;
        compliance in Orthodontic patients.&#xD;
  &#xD;
        The purpose of this study was to determine probable effect of pre-treatment photographs on&#xD;
        oral hygiene maintenance in orthodontic patients. To our knowledge no such study has been&#xD;
        done previously. This would help us in making patients understand the importance of oral&#xD;
        hygiene maintenance. The results will also be used by other practitioners.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Randomized Controlled Trial Design:&#xD;
  &#xD;
          1. Participants:&#xD;
  &#xD;
             Orthodontic patients.&#xD;
  &#xD;
          2. Intervention:&#xD;
  &#xD;
             Patients' own pre-treatment dental photographs.&#xD;
  &#xD;
          3. Study group:&#xD;
  &#xD;
             Orthodontic patients who are shown dental photographs.&#xD;
  &#xD;
          4. Comparison group:&#xD;
  &#xD;
             Orthodontic patients who are not shown dental photographs.&#xD;
  &#xD;
          5. Outcome:&#xD;
  &#xD;
             Good oral hygiene measured by plaque index.&#xD;
  &#xD;
          6. Block randomization:&#xD;
  &#xD;
             To decrease selection or accidental bias patients were assigned group A or B using block&#xD;
             randomization technique. Blocks were created, size of each block was 4 with 2 'A's and 2&#xD;
             'B's. For 2 groups there were 6 possible blocks. From random number table a random&#xD;
             sequence of blocks was generated. Patients were then assigned groups according to&#xD;
             blocks.&#xD;
  &#xD;
          7. Subjects:&#xD;
  &#xD;
        I. Group 1:&#xD;
  &#xD;
        Included 30 patients and these patients were shown full extra-oral and intra-oral&#xD;
        photographs.&#xD;
  &#xD;
        II. Group 2:&#xD;
  &#xD;
        Included 30 patients and these patients were not shown any photographs. All subjects received&#xD;
        similar oral hygiene instructions. Those in group A were shown their photographs while those&#xD;
        in B were not shown any photographs.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 10, 2020</start_date>
    <completion_date type="Actual">July 4, 2021</completion_date>
    <primary_completion_date type="Actual">July 4, 2021</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>Double (Participant, Investigator)</masking>
      <masking_description>It was a double blinded randomized controlled trial. Patients and the investigator recording indices were blinded.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Good oral hygiene measured by plaque index</measure>
      <time_frame>3 months</time_frame>
      <description>Plaque scores at T0 and T1 were compared to assess improvement in oral hygiene</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">60</enrollment>
    <condition>Oral Hygiene</condition>
    <condition>Photographs</condition>
    <arm_group>
      <arm_group_label>Orthodontic patients who are shown pre-treatment photographs</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group A included 30 patients who were shown their pre-treatment extra-oral and intra-oral photographs.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Orthodontic patients who were not shown pre-treatment photographs</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Group B included 30 patients who were not shown their pre-treatment extra-oral and intra-oral photographs.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Showing Pre-treatment photographs of the patient</intervention_name>
      <description>Extra-oral and intra-oral dental photographs of patients were taken before starting Orthodontic treatment. Experimental group were shown their photographs while control group were not shown their photographs.</description>
      <arm_group_label>Orthodontic patients who are shown pre-treatment photographs</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients of both genders&#xD;
  &#xD;
            -  Between age 13-25 years&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with previous orthodontic treatment&#xD;
  &#xD;
            -  Handicapped patients&#xD;
  &#xD;
            -  Patients with any systemic disease&#xD;
  &#xD;
            -  Generalized periodontal disease&#xD;
  &#xD;
            -  Congenital malformations&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>13 Years</minimum_age>
      <maximum_age>25 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Rehmat Memorial Dental Postgraduate Teaching Hospital</name>
        <address>
          <city>Abbottabad</city>
          <state>Khyber Pakhtaunkha</state>
          <zip>22010</zip>
          <country>Pakistan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Rehmat Memorial Post Graduate Dental Teaching Hospital</investigator_affiliation>
      <investigator_full_name>Eizza Niaz</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Oral hygiene</keyword>
    <keyword>Photographs</keyword>
    <keyword>Dental</keyword>
    <keyword>Orthodontics</keyword>
    <keyword>Periodontitis</keyword>
    <keyword>Gingivitis</keyword>
    <keyword>Index</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>August 20, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/97/NCT06010797/Prot_SAP_ICF_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06010797
  org study id: RehmatMPGDTH
  nct id: NCT06010797
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Dental photography is an essential component of orthodontic treatment. Photographs enable the
        clinician to keep record of different stages of treatment. Other uses are for treatment
        planning, communicating with the patients and other specialists, comparison of pre-treatment
        and post-treatment changes, for research purpose and also for patient's motivation. Images
        captured before, during and after treatment provide legal protection when necessary. In the
        orthodontic discipline, at least three extra-oral and five intra-oral photographs are
        recommended. Extra-oral photographs should correctly reflect patient's appearance and
        intra-oral photographs should show complete dentition and occlusion.
  
        Oral hygiene is controlled by the patient during orthodontic treatment which requires proper
        motivation. Motivational methods are classified as chair-side education, message reminders,
        behavioral modification and Hawthorne effect. Patients' motivation plays an important role in
        maintaining favorable oral hygiene. A number of studies have shown the effect of motivational
        methods on oral hygiene improvement. In one of these studies, 80 patients who needed
        orthodontic treatment were selected and randomly distributed into two equal groups as control
        group and study group. The study group patients were included in a Whatsapp where they shared
        their own photographs (selfies) and received text messages, while the control group patients
        were not included in any Whatsapp group. Baseline PI scoring was 0.48(0.34) in control group
        and 0.41(0.32) in study group, After 3 months PI scoring was 1.72(0.33) in control group and
        1.68(0.40) in study group. Results showed that sharing of selfies improves oral hygiene
        compliance in Orthodontic patients.
  
        The purpose of this study was to determine probable effect of pre-treatment photographs on
        oral hygiene maintenance in orthodontic patients. To our knowledge no such study has been
        done previously. This would help us in making patients understand the importance of oral
        hygiene maintenance. The results will also be used by other practitioners.
  Randomized Controlled Trial Design:
  
          1. Participants:
  
             Orthodontic patients.
  
          2. Intervention:
  
             Patients' own pre-treatment dental photographs.
  
          3. Study group:
  
             Orthodontic patients who are shown dental photographs.
  
          4. Comparison group:
  
             Orthodontic patients who are not shown dental photographs.
  
          5. Outcome:
  
             Good oral hygiene measured by plaque index.
  
          6. Block randomization:
  
             To decrease selection or accidental bias patients were assigned group A or B using block
             randomization technique. Blocks were created, size of each block was 4 with 2 'A's and 2
             'B's. For 2 groups there were 6 possible blocks. From random number table a random
             sequence of blocks was generated. Patients were then assigned groups according to
             blocks.
  
          7. Subjects:
  
        I. Group 1:
  
        Included 30 patients and these patients were shown full extra-oral and intra-oral
        photographs.
  
        II. Group 2:
  
        Included 30 patients and these patients were not shown any photographs. All subjects received
        similar oral hygiene instructions. Those in group A were shown their photographs while those
        in B were not shown any photographs.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Participant, Investigator)
  masking description: It was a double blinded randomized controlled trial. Patients and the investigator recording indices were blinded.
  measure: Good oral hygiene measured by plaque index
  time frame: 3 months
  description: Plaque scores at T0 and T1 were compared to assess improvement in oral hygiene
  arm group label: Orthodontic patients who are shown pre-treatment photographs
  arm group type: Experimental
  description: Group A included 30 patients who were shown their pre-treatment extra-oral and intra-oral photographs.
  arm group label: Orthodontic patients who were not shown pre-treatment photographs
  arm group type: No Intervention
  description: Group B included 30 patients who were not shown their pre-treatment extra-oral and intra-oral photographs.
  intervention type: Device
  intervention name: Showing Pre-treatment photographs of the patient
  description: Extra-oral and intra-oral dental photographs of patients were taken before starting Orthodontic treatment. Experimental group were shown their photographs while control group were not shown their photographs.
  arm group label: Orthodontic patients who are shown pre-treatment photographs
  criteria: 
  gender: All
  minimum age: 13 Years
  maximum age: 25 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Pakistan
  responsible party type: Principal Investigator
  investigator affiliation: Rehmat Memorial Post Graduate Dental Teaching Hospital
  investigator full name: Eizza Niaz
  investigator title: Principal Investigator
  sharing ipd: No
  provided document: 