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/NCT05995431</url>
    </required_header>
    <id_info>
      <org_study_id>PRIYANKAPERIO2023</org_study_id>
      <nct_id>NCT05995431</nct_id>
    </id_info>
    <brief_title>Impact of Bruxism in the Outcome of Subgingival Instrumentation for the Management of Stage 2 and Stage 3 Periodontitis.</brief_title>
    <official_title>Impact of Bruxism in the Outcome of Subgingival Instrumentation for the Management of Stage 2 and Stage 3 Periodontitis: A Comparative Interventional Study.</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>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>
        Bruxism is a multifaceted phenomenon that has been associated with several factors mediated&#xD;
        by the central nervous system3. Bruxism is an umbrella term grouping different motor&#xD;
        phenomenon. 'Bruxism is a repetitive jaw-muscle activity characterized by clenching or&#xD;
        grinding of the teeth and/or by bracing or thrusting of the mandible. Bruxism has two&#xD;
        distinct circadian manifestations: it can occur during sleep (indicated as sleep bruxism) or&#xD;
        during wakefulness (indicated as awake bruxism5.&#xD;
  &#xD;
        Sleep bruxism is considered to be a putative exacerbating factor, rather than a causative&#xD;
        factor of periodontal disease and night-guards have been used as a counter measure. Since the&#xD;
        periodontium in sleep bruxism patients suffers from excessive occlusal force for long periods&#xD;
        of time during sleep, the function of the periodontium in such patients may differ from that&#xD;
        in patients without sleep bruxism. Awake bruxism is defined as masticatory muscle activity&#xD;
        during wakefulness that is characterized by repetitive or sustained tooth contact and by&#xD;
        bracing or thrusting of the mandible.Given the potential impact of abnormal forces on the&#xD;
        periodontium, understanding the relationship between bruxism and periodontal disease is&#xD;
        crucial for the prevention and management of these conditions. This study aims to explore the&#xD;
        mechanisms by which bruxism affects the periodontium and to assess the impact of bruxism in&#xD;
        the outcome of subgingival instrumentation for the management of Stage 2 and Stage 3&#xD;
        periodontitis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        AIM : To study the impact of bruxism in the outcome of subgingival instrumentation for the&#xD;
        management of Stage 2 and Stage 3 periodontitis.&#xD;
  &#xD;
        OBJECTIVES:&#xD;
  &#xD;
        To assess the association of bruxism with periodontitis. STUDY DESIGN: An interventional&#xD;
        study will be conducted in the Department of Periodontics and Oral implantology PGIDS,&#xD;
        Rohtak.&#xD;
  &#xD;
        STUDY SETTING: Hospital based study- patients diagnosed with Stage 2 and Stage 3&#xD;
        Periodontitis associated with bruxism will be recruited in study from OPD.&#xD;
  &#xD;
        TIME FRAME: 12-14 months&#xD;
  &#xD;
        Sociodemographic variables:&#xD;
  &#xD;
        Sociodemographic data comprises of :&#xD;
  &#xD;
          1. Gender&#xD;
  &#xD;
          2. Age&#xD;
  &#xD;
          3. Educational level,&#xD;
  &#xD;
          4. Occupation status (student, employed, unemployed or retired), 5 Marital status (single,&#xD;
             married, divorced or widowed),&#xD;
  &#xD;
        6. Average family monthly income.&#xD;
  &#xD;
        POPULATION:&#xD;
  &#xD;
        Systemically healthy patients with generalized periodontitis : stage 2 and stage 3 of age&#xD;
        group of 30-50 years will be recruited in the study from OPD of Periodontology. Recruitment&#xD;
        of the patients for the study will be based on eligibility criteria after obtaining informed&#xD;
        and written consent.&#xD;
  &#xD;
        SAMPLE SIZE:&#xD;
  &#xD;
        Sample size determination was done by using G power software. Taking alpha= 0.5 and power of&#xD;
        90% , minimum 23 patients in each group are required to detect a clinically relevant change&#xD;
        of 1mm in clinical attachment level with standard deviation of 1mm between both the groups.&#xD;
        Hence a total of 58 patients (29 in each group) will be included in the study expecting a 25%&#xD;
        drop out rate.&#xD;
  &#xD;
        METHOD:&#xD;
  &#xD;
        Patients fulfilling the eligibility criteria will be enrolled in the study after obtaining&#xD;
        the informed consent. Periodontal parameters will be assessed which include clinical&#xD;
        attachment level (CAL), periodontal pocket depth (PPD), bleeding on probing (BOP), Gingival&#xD;
        index (GI),Tooth mobility.&#xD;
  &#xD;
        SAMPLE SIZE:&#xD;
  &#xD;
        Sample size determination was done by using G power software. Taking alpha= 0.5 and power of&#xD;
        90% , minimum 23 patients in each group are required to detect a clinically relevant change&#xD;
        of 1mm in clinical attachment level with standard deviation of 1mm between both the groups.&#xD;
        Hence a total of 58 patients (29 in each group) will be included in the study expecting a 25%&#xD;
        drop out rate.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Clinical Attachment Level (CAL)</measure>
      <time_frame>BASELINE,2 MONTHS ,3 MONTHS,6 MONTHS</time_frame>
      <description>CLINICAL ATTACHMENT LEVEL(CAL) Clinical Attachment Level will be measured as a distance betweenfrom the base of the clinicalpocket and the cemencemento-enamel junction (CEJ).Measurements will be made atsites 6 of involved tooth- mesio-buccal, mid-buccal, dismdistobuccal, mesio-lingual, mid-lingual, disto-lingual using UNC-15 probe. Measurements will be rounded to the nearest whole millimetre.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Bleeding on probing (BOP)</measure>
      <time_frame>BASELINE,2 MONTHS,3 MONTHS 6 MONTHS</time_frame>
      <description>BLEEDING ON PROBING (BOP) BOP will recorded as 1 (present) if it occurred within 15 sec of probing and 0 (absent) if no bleeding occurred. It will be calculated in %. After adding all the scores, total score will be divided by the total no. of surfaces accessed and multiplied by 100. It will be designed as&#xD;
  % sites with bleeding on probing.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pocket Probing Depth (PPD)</measure>
      <time_frame>BASELINE, 2 MONTHS, 3MONTHS, 6 MONTHS</time_frame>
      <description>PROBING POCKET DEPTH (PD):Probing pocket depth will be measured as the distance from the gingival margin to the base of the clinical pocket. The probing depth measurements will be assessed using a calibrated manual periodontal probe (PCP- UNC 15 Hu-Friedy, Chicago, IL, USA). The probe 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. Measurements will be rounded to the nearest whole millimetre.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">58</enrollment>
    <condition>Periodontitis</condition>
    <condition>Bruxism</condition>
    <arm_group>
      <arm_group_label>PERIODONTITIS STAGE 2 AND STAGE 3 WITH BRUXISM</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All the participants will undergo scaling and root planing</description>
    </arm_group>
    <arm_group>
      <arm_group_label>AGE MATCHED PATIENTS WITH STAGE 2 AND STAGE 3 PERIODONTITIS WITHOUT BRUXISM</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>All the participants will undergo subgingival instrumentation</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>scaling and root planing</intervention_name>
      <description>All the participants will undergo scaling and root planing</description>
      <arm_group_label>PERIODONTITIS STAGE 2 AND STAGE 3 WITH BRUXISM</arm_group_label>
      <other_name>SRP</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Subgingival instrumentation</intervention_name>
      <description>All the participants will undergo subgingival instrumentation</description>
      <arm_group_label>AGE MATCHED PATIENTS WITH STAGE 2 AND STAGE 3 PERIODONTITIS WITHOUT BRUXISM</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          TEST GROUP&#xD;
  &#xD;
            -  Systemically healthy patients&#xD;
  &#xD;
            -  Patient having stage 2 or stage 3 periodontitis with bruxism Age between 30-50 years&#xD;
  &#xD;
            -  Minimum 20 teeth present in oral cavity&#xD;
  &#xD;
          CONTROL GROUP&#xD;
  &#xD;
            -  Systemically healthy patients&#xD;
  &#xD;
            -  Patient having stage 2 or stage 3 periodontitis without bruxism&#xD;
  &#xD;
            -  Age between 30-50 years&#xD;
  &#xD;
            -  Minimum 20 teeth present in oral cavity&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of systemic disease such as diabetes or autoimmune disease&#xD;
  &#xD;
            -  History of drugs having the potential impact on periodontal status like phenytoin,&#xD;
               cyclosporin, calcium-channel blockers or antidepressant drugs&#xD;
  &#xD;
            -  Pregnant or lactating females&#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>Priyanka Chandela, BDS</last_name>
      <role>Principal Investigator</role>
      <affiliation>PT BD SHARMA UHSR, HARYANA</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>RAJINDER KR SHARMA, MDS</last_name>
      <phone>9416358222</phone>
      <email>rksharmamds@yahoo.in</email>
    </overall_contact>
    <location>
      <facility>
        <name>Post Graduate Institute of Dental Sciences</name>
        <address>
          <city>Rohtak</city>
          <state>Haryana</state>
          <zip>124001</zip>
          <country>India</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>India</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 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>
      <mesh_term>Bruxism</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/NCT05995431
  org study id: PRIYANKAPERIO2023
  nct id: NCT05995431
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Bruxism is a multifaceted phenomenon that has been associated with several factors mediated
        by the central nervous system3. Bruxism is an umbrella term grouping different motor
        phenomenon. 'Bruxism is a repetitive jaw-muscle activity characterized by clenching or
        grinding of the teeth and/or by bracing or thrusting of the mandible. Bruxism has two
        distinct circadian manifestations: it can occur during sleep (indicated as sleep bruxism) or
        during wakefulness (indicated as awake bruxism5.
  
        Sleep bruxism is considered to be a putative exacerbating factor, rather than a causative
        factor of periodontal disease and night-guards have been used as a counter measure. Since the
        periodontium in sleep bruxism patients suffers from excessive occlusal force for long periods
        of time during sleep, the function of the periodontium in such patients may differ from that
        in patients without sleep bruxism. Awake bruxism is defined as masticatory muscle activity
        during wakefulness that is characterized by repetitive or sustained tooth contact and by
        bracing or thrusting of the mandible.Given the potential impact of abnormal forces on the
        periodontium, understanding the relationship between bruxism and periodontal disease is
        crucial for the prevention and management of these conditions. This study aims to explore the
        mechanisms by which bruxism affects the periodontium and to assess the impact of bruxism in
        the outcome of subgingival instrumentation for the management of Stage 2 and Stage 3
        periodontitis.
  AIM : To study the impact of bruxism in the outcome of subgingival instrumentation for the
        management of Stage 2 and Stage 3 periodontitis.
  
        OBJECTIVES:
  
        To assess the association of bruxism with periodontitis. STUDY DESIGN: An interventional
        study will be conducted in the Department of Periodontics and Oral implantology PGIDS,
        Rohtak.
  
        STUDY SETTING: Hospital based study- patients diagnosed with Stage 2 and Stage 3
        Periodontitis associated with bruxism will be recruited in study from OPD.
  
        TIME FRAME: 12-14 months
  
        Sociodemographic variables:
  
        Sociodemographic data comprises of :
  
          1. Gender
  
          2. Age
  
          3. Educational level,
  
          4. Occupation status (student, employed, unemployed or retired), 5 Marital status (single,
             married, divorced or widowed),
  
        6. Average family monthly income.
  
        POPULATION:
  
        Systemically healthy patients with generalized periodontitis : stage 2 and stage 3 of age
        group of 30-50 years will be recruited in the study from OPD of Periodontology. Recruitment
        of the patients for the study will be based on eligibility criteria after obtaining informed
        and written consent.
  
        SAMPLE SIZE:
  
        Sample size determination was done by using G power software. Taking alpha= 0.5 and power of
        90% , minimum 23 patients in each group are required to detect a clinically relevant change
        of 1mm in clinical attachment level with standard deviation of 1mm between both the groups.
        Hence a total of 58 patients (29 in each group) will be included in the study expecting a 25%
        drop out rate.
  
        METHOD:
  
        Patients fulfilling the eligibility criteria will be enrolled in the study after obtaining
        the informed consent. Periodontal parameters will be assessed which include clinical
        attachment level (CAL), periodontal pocket depth (PPD), bleeding on probing (BOP), Gingival
        index (GI),Tooth mobility.
  
        SAMPLE SIZE:
  
        Sample size determination was done by using G power software. Taking alpha= 0.5 and power of
        90% , minimum 23 patients in each group are required to detect a clinically relevant change
        of 1mm in clinical attachment level with standard deviation of 1mm between both the groups.
        Hence a total of 58 patients (29 in each group) will be included in the study expecting a 25%
        drop out rate.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Clinical Attachment Level (CAL)
  time frame: BASELINE,2 MONTHS ,3 MONTHS,6 MONTHS
  description: CLINICAL ATTACHMENT LEVEL(CAL) Clinical Attachment Level will be measured as a distance betweenfrom the base of the clinicalpocket and the cemencemento-enamel junction (CEJ).Measurements will be made atsites 6 of involved tooth- mesio-buccal, mid-buccal, dismdistobuccal, mesio-lingual, mid-lingual, disto-lingual using UNC-15 probe. Measurements will be rounded to the nearest whole millimetre.
  measure: Bleeding on probing (BOP)
  time frame: BASELINE,2 MONTHS,3 MONTHS 6 MONTHS
  description: BLEEDING ON PROBING (BOP) BOP will recorded as 1 (present) if it occurred within 15 sec of probing and 0 (absent) if no bleeding occurred. It will be calculated in %. After adding all the scores, total score will be divided by the total no. of surfaces accessed and multiplied by 100. It will be designed as
  % sites with bleeding on probing.
  measure: Pocket Probing Depth (PPD)
  time frame: BASELINE, 2 MONTHS, 3MONTHS, 6 MONTHS
  description: PROBING POCKET DEPTH (PD):Probing pocket depth will be measured as the distance from the gingival margin to the base of the clinical pocket. The probing depth measurements will be assessed using a calibrated manual periodontal probe (PCP- UNC 15 Hu-Friedy, Chicago, IL, USA). The probe 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. Measurements will be rounded to the nearest whole millimetre.
  arm group label: PERIODONTITIS STAGE 2 AND STAGE 3 WITH BRUXISM
  arm group type: Experimental
  description: All the participants will undergo scaling and root planing
  arm group label: AGE MATCHED PATIENTS WITH STAGE 2 AND STAGE 3 PERIODONTITIS WITHOUT BRUXISM
  arm group type: Active Comparator
  description: All the participants will undergo subgingival instrumentation
  intervention type: Procedure
  intervention name: scaling and root planing
  description: All the participants will undergo scaling and root planing
  arm group label: PERIODONTITIS STAGE 2 AND STAGE 3 WITH BRUXISM
  other name: SRP
  intervention type: Procedure
  intervention name: Subgingival instrumentation
  description: All the participants will undergo subgingival instrumentation
  arm group label: AGE MATCHED PATIENTS WITH STAGE 2 AND STAGE 3 PERIODONTITIS WITHOUT BRUXISM
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Priyanka Chandela, BDS
  role: Principal Investigator
  affiliation: PT BD SHARMA UHSR, HARYANA
  last name: RAJINDER KR SHARMA, MDS
  phone: 9416358222
  email: rksharmamds@yahoo.in
  facility: 
  country: India
  responsible party type: Sponsor
  mesh term: Periodontitis
  mesh term: Bruxism
  sharing ipd: No