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/NCT06024447</url>
    </required_header>
    <id_info>
      <org_study_id>JANVIPERIO2023</org_study_id>
      <nct_id>NCT06024447</nct_id>
    </id_info>
    <brief_title>Impact of Subgingival Instrumentation on Masticatory Performance and Psychological Distress</brief_title>
    <official_title>Impact of Subgingival Instrumentation on Masticatory Performance and Psychological Distress in Periodontitis: Stage III and IV</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Postgraduate Institute of Dental Sciences Rohtak</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Postgraduate Institute of Dental Sciences Rohtak</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Patients of Stage III and Stage IV Periodontitis will be assessed for masticatory dysfunction&#xD;
        and psychological distress. Subgingival Instrumentation will be done for treating&#xD;
        periodontitis. Patients will be re-evaluated after 2 and 3 months in order to assess any&#xD;
        change in masticatory dysfunction and psychological distress by improved periodontal health.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Literature reveals that there occurs masticatory dysfunction in patients with Stage III and&#xD;
        IV Periodontitis. It has been hypothesized that masticatory dysfunction along with halitosis&#xD;
        and aesthetics of the patient can have an effect on the psychological distress in a chronic&#xD;
        state.&#xD;
  &#xD;
        Patients of Stage III and Stage IV Periodontitis with the following criteria will be included&#xD;
        :&#xD;
  &#xD;
          1. Adult patients with age group 30-50 years diagnosed with stage III/IV generalized&#xD;
             periodontitis.&#xD;
  &#xD;
          2. Presence of minimum 20 teeth (Eichner group A1, A2, A3) excluding third molars.&#xD;
  &#xD;
        Exclusion Criteria: Patients with&#xD;
  &#xD;
          1. Systemic diseases that may affect periodontal disease progression or outcome of&#xD;
             treatment (diabetes, autoimmune diseases)&#xD;
  &#xD;
          2. Systemic diseases that may affect masticatory ability of the patient (sarcopenia, TMJ&#xD;
             disorders, Xerostomia, Acute Pulpitis)&#xD;
  &#xD;
          3. History of periodontal treatment within the 6 months&#xD;
  &#xD;
          4. Patients wearing orthodontic appliances&#xD;
  &#xD;
          5. Diagnosed psychiatric disorder&#xD;
  &#xD;
          6. History of antibiotic use within the previous 3 months&#xD;
  &#xD;
          7. History of use of Steroid, immunosuppressive and psychiatric drugs&#xD;
  &#xD;
          8. Pregnant and lactating women&#xD;
  &#xD;
          9. Smoking or substance abuse&#xD;
  &#xD;
         10. History of Menopause&#xD;
  &#xD;
        Periodontal clinical parameters:&#xD;
  &#xD;
        Plaque Index, Gingival Index, Bleeding on Probing, Probing Pocket Depth, Clinical Attachment&#xD;
        Level, Mobility Psychological Parameters: Hospital Anxiety and Depression Scale -14 and&#xD;
        Depression Anxiety and Stress Scale -21 Quality of Masticatory Dysfunction Questionnaire and&#xD;
        Objective evaluation of Masticatory Performance by mixing ability of Hubba Bubba chewing gum.&#xD;
  &#xD;
        The sample of 84 patients consisting of 42 cases and 42 controls. The patients will be&#xD;
        re-evaluated at 2 and 3 months follow up for clinical periodontal parameters, masticatory&#xD;
        performance and psychological distress.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">October 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 15, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Masticatory performance</measure>
      <time_frame>Baseline, 2 months, 3 months</time_frame>
      <description>Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum, through optoelectronic analysis using a software. Subjective masticatory performance will be calculated using The Quality of Masticatory Function questionnaire which consists of 29 questions related to frequency and difficulty of chewing different types of foods in the previous 2 weeks.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hospital Anxiety and Depression Scale 14</measure>
      <time_frame>Baseline, 2 months, 3 months</time_frame>
      <description>The HADS constitutes 14 items grouped into two subscales: &quot;anxiety subscale&quot; (HADS-A), as well as &quot;depression subscale&quot; (HADS-D). The responses to the items are graded from 0 (absence of manifestations) to 3 (severe manifestations). Scores are summated to yield the total score, and greater scores indicate more severe anxiety, as well as depressive indications. DASS-21 measures emotional distress in three subcategories of depression (e.g., loss of self-esteem/incentives and depressed mood), anxiety (e.g., fear and anticipation of negative events), and stress (e.g., persistent state of over arousal and low frustration tolerance). It is a self-reporting questionnaire with 21 items (seven items for each category) based on a four-point rating scale. Higher score represents more severe emotional distress.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Depression Anxiety and Stress Scale 21</measure>
      <time_frame>Baseline, 2 months, 3 months</time_frame>
      <description>DASS-21 measures emotional distress in three subcategories of depression (e.g., loss of self-esteem/incentives and depressed mood), anxiety (e.g., fear and anticipation of negative events), and stress (e.g., persistent state of over arousal and low frustration tolerance). It is a self-reporting questionnaire with 21 items (seven items for each category) based on a four-point rating scale. Higher score represents more severe emotional distress.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pocket Probing Depth</measure>
      <time_frame>Baseline, 2 months, 3 months</time_frame>
      <description>The probe UNC 15 will be inserted with a firm, gentle pressure to the bottom of the pocket and maintained parallel to the vertical axis of the tooth. Measurements will be noted at 6 sites of involved tooth - mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical attachment level</measure>
      <time_frame>Baseline, 2 months, 3 months</time_frame>
      <description>Clinical Attachment Level will be measured as a distance between from the base of the clinical pocket and the cemento-enamel junction (CEJ). Measurements will be made at 6 sites of involved tooth.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">92</enrollment>
    <condition>Periodontitis</condition>
    <arm_group>
      <arm_group_label>Stage III and Stage IV Periodontitis</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Subgingival Instrumentation will be performed in patients with Stage III and Stage IV periodontitis.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Subgingival Instrumentation</intervention_name>
      <description>Subgingival Instrumentation will be performed in patients with Stage III and IV periodontitis.</description>
      <arm_group_label>Stage III and Stage IV Periodontitis</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients with age group 30-50 years diagnosed with stage III/IV generalized&#xD;
               periodontitis.&#xD;
  &#xD;
            -  Presence of minimum 20 teeth (Eichner group A1, A2, A3) excluding third molars.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Systemic diseases that may affect periodontal disease progression or outcome of&#xD;
               treatment (diabetes, autoimmune diseases)&#xD;
  &#xD;
            -  Systemic diseases that may affect masticatory ability of the patient (sarcopenia, TMJ&#xD;
               disorders, Xerostomia, Acute Pulpitis)&#xD;
  &#xD;
            -  Periodontal treatment within the 6 months&#xD;
  &#xD;
            -  Patients wearing orthodontic appliances&#xD;
  &#xD;
            -  Any diagnosed psychiatric disorder&#xD;
  &#xD;
            -  Antibiotic use within the previous 3 months&#xD;
  &#xD;
            -  Steroid, immunosuppressive and psychiatric drug use&#xD;
  &#xD;
            -  Pregnant and lactating women&#xD;
  &#xD;
            -  History of menopause&#xD;
  &#xD;
            -  Smoking or substance abuse&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Janvi Janvi, BDS</last_name>
      <role>Principal Investigator</role>
      <affiliation>PGIDS Rohtak</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sanjay Tewari, MDS</last_name>
      <phone>91-1262-283876</phone>
      <email>principalpgids@yahoo.in</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Periodontitis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06024447
  org study id: JANVIPERIO2023
  nct id: NCT06024447
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Patients of Stage III and Stage IV Periodontitis will be assessed for masticatory dysfunction
        and psychological distress. Subgingival Instrumentation will be done for treating
        periodontitis. Patients will be re-evaluated after 2 and 3 months in order to assess any
        change in masticatory dysfunction and psychological distress by improved periodontal health.
  Literature reveals that there occurs masticatory dysfunction in patients with Stage III and
        IV Periodontitis. It has been hypothesized that masticatory dysfunction along with halitosis
        and aesthetics of the patient can have an effect on the psychological distress in a chronic
        state.
  
        Patients of Stage III and Stage IV Periodontitis with the following criteria will be included
        :
  
          1. Adult patients with age group 30-50 years diagnosed with stage III/IV generalized
             periodontitis.
  
          2. Presence of minimum 20 teeth (Eichner group A1, A2, A3) excluding third molars.
  
        Exclusion Criteria: Patients with
  
          1. Systemic diseases that may affect periodontal disease progression or outcome of
             treatment (diabetes, autoimmune diseases)
  
          2. Systemic diseases that may affect masticatory ability of the patient (sarcopenia, TMJ
             disorders, Xerostomia, Acute Pulpitis)
  
          3. History of periodontal treatment within the 6 months
  
          4. Patients wearing orthodontic appliances
  
          5. Diagnosed psychiatric disorder
  
          6. History of antibiotic use within the previous 3 months
  
          7. History of use of Steroid, immunosuppressive and psychiatric drugs
  
          8. Pregnant and lactating women
  
          9. Smoking or substance abuse
  
         10. History of Menopause
  
        Periodontal clinical parameters:
  
        Plaque Index, Gingival Index, Bleeding on Probing, Probing Pocket Depth, Clinical Attachment
        Level, Mobility Psychological Parameters: Hospital Anxiety and Depression Scale -14 and
        Depression Anxiety and Stress Scale -21 Quality of Masticatory Dysfunction Questionnaire and
        Objective evaluation of Masticatory Performance by mixing ability of Hubba Bubba chewing gum.
  
        The sample of 84 patients consisting of 42 cases and 42 controls. The patients will be
        re-evaluated at 2 and 3 months follow up for clinical periodontal parameters, masticatory
        performance and psychological distress.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Masticatory performance
  time frame: Baseline, 2 months, 3 months
  description: Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum, through optoelectronic analysis using a software. Subjective masticatory performance will be calculated using The Quality of Masticatory Function questionnaire which consists of 29 questions related to frequency and difficulty of chewing different types of foods in the previous 2 weeks.
  measure: Hospital Anxiety and Depression Scale 14
  time frame: Baseline, 2 months, 3 months
  description: The HADS constitutes 14 items grouped into two subscales: "anxiety subscale" (HADS-A), as well as "depression subscale" (HADS-D). The responses to the items are graded from 0 (absence of manifestations) to 3 (severe manifestations). Scores are summated to yield the total score, and greater scores indicate more severe anxiety, as well as depressive indications. DASS-21 measures emotional distress in three subcategories of depression (e.g., loss of self-esteem/incentives and depressed mood), anxiety (e.g., fear and anticipation of negative events), and stress (e.g., persistent state of over arousal and low frustration tolerance). It is a self-reporting questionnaire with 21 items (seven items for each category) based on a four-point rating scale. Higher score represents more severe emotional distress.
  measure: Depression Anxiety and Stress Scale 21
  time frame: Baseline, 2 months, 3 months
  description: DASS-21 measures emotional distress in three subcategories of depression (e.g., loss of self-esteem/incentives and depressed mood), anxiety (e.g., fear and anticipation of negative events), and stress (e.g., persistent state of over arousal and low frustration tolerance). It is a self-reporting questionnaire with 21 items (seven items for each category) based on a four-point rating scale. Higher score represents more severe emotional distress.
  measure: Pocket Probing Depth
  time frame: Baseline, 2 months, 3 months
  description: The probe UNC 15 will be inserted with a firm, gentle pressure to the bottom of the pocket and maintained parallel to the vertical axis of the tooth. Measurements will be noted at 6 sites of involved tooth - mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual.
  measure: Clinical attachment level
  time frame: Baseline, 2 months, 3 months
  description: Clinical Attachment Level will be measured as a distance between from the base of the clinical pocket and the cemento-enamel junction (CEJ). Measurements will be made at 6 sites of involved tooth.
  arm group label: Stage III and Stage IV Periodontitis
  arm group type: Other
  description: Subgingival Instrumentation will be performed in patients with Stage III and Stage IV periodontitis.
  intervention type: Procedure
  intervention name: Subgingival Instrumentation
  description: Subgingival Instrumentation will be performed in patients with Stage III and IV periodontitis.
  arm group label: Stage III and Stage IV Periodontitis
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Janvi Janvi, BDS
  role: Principal Investigator
  affiliation: PGIDS Rohtak
  last name: Sanjay Tewari, MDS
  phone: 91-1262-283876
  email: principalpgids@yahoo.in
  responsible party type: Sponsor
  mesh term: Periodontitis
  sharing ipd: No