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/NCT06027151</url>
    </required_header>
    <id_info>
      <org_study_id>Riphah/IIMC/IRC/22/2070</org_study_id>
      <nct_id>NCT06027151</nct_id>
    </id_info>
    <brief_title>Comparing the Efficacy of Metronidazole and Minocycline Gels for the Treatment of Diabetic Periodontitis Patients</brief_title>
    <official_title>Comparing the Efficacy of Metronidazole and Minocycline Gels for the Treatment of Diabetic Periodontitis Patients</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This clinical study randomized 380 diabetic chronic periodontitis patients into 4 groups:&#xD;
        scaling and root planning alone (group I), scaling and root planning plus metronidazole gel&#xD;
        (group II), scaling and root planning plus minocycline gel (group III), and scaling and root&#xD;
        planning plus both metronidazole and minocycline gels (group IV). Periodontal measurements&#xD;
        including probing depth, gingival color and texture, bleeding on probing, clinical attachment&#xD;
        level, and recession were recorded at baseline, 7 days, and 15 days.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        It was a clinical trial with four arms. The research was carried out at the Pharmacology&#xD;
        Department, IIMC Riphah University, Rawalpindi. The sample size was calculated to be 380&#xD;
        using the prevalence of disease, z-score, and 5% margin of error. Written informed consent&#xD;
        was obtained from the participants. The patients being treated for chronic periodontitis were&#xD;
        randomly divided into four groups (I, II, III, and IV). Patients in Group I were subjected to&#xD;
        Scaling and root planning alone. Group II patients were given metronidazole gel following&#xD;
        Scaling and root planning. Minocycline gel was locally applied subsequent to scaling and root&#xD;
        planning in Group III patients. The combination of metronidazole gel and minocycline gel was&#xD;
        administered after Scaling and root planning in Group IV patients. Scaling and root planning&#xD;
        of all the patients was done. Periodontal probing depth, the color of the gingiva, texture of&#xD;
        the gingiva, bleeding on probing, clinical attachment level, and recession were recorded for&#xD;
        each patient at baseline visit, after 7 days, and after 15 days to determine and compare the&#xD;
        efficacy of local administration of drugs.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 6, 2022</start_date>
    <completion_date type="Actual">July 31, 2023</completion_date>
    <primary_completion_date type="Actual">July 31, 2023</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>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>single blind, patient was unaware of which drug they were administered. It was done by covering the syringes with colored tapes</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>PERIODONTAL POCKET DEPTH (PPD)</measure>
      <time_frame>15 days</time_frame>
      <description>Periodontal pocket depth was measured in mm using a WHO (CPITN) periodontal probe.&#xD;
  Baseline periodontal probing depth was measured before application of drug. It was remeasured on 7th day and 15th day. Reduction in probing depth indicates improvement on follow up visits.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>COLOR OF GINGIVA</measure>
      <time_frame>15 days</time_frame>
      <description>Color of gingiva is observed at baseline visit, on 7th day and 15th day. Healthy gingiva is coral pink in color while diseased gingiva is erythematous cyanotic.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>TEXTURE OF GINGIVA</measure>
      <time_frame>15 days</time_frame>
      <description>Texture of gingiva is observed at baseline visit, on 7th day and 15th day. Healthy gingiva is matte and stippled. Diseased gingiva is smooth and shiny.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>BLEEDING ON PROBING (BOP)</measure>
      <time_frame>15 days</time_frame>
      <description>It was determined whether the site was bleeding on probing or not. Bleeding on probing is observed on the baseline visit, 7th day, and 15th day. If the gingiva is not bleeding then it is considered as normal.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CLINICAL ATTACHMENT Level</measure>
      <time_frame>15 days</time_frame>
      <description>Distance from cementoenamel junction to depth of pocket is measured with the help of CPITN probe. Readings are taken on baseline visit, 7th day and 15th day. Severity index is as follows.&#xD;
  Healthy gingiva- 0mm CAL Mild: 1- or 2-mm CAL Moderate: 3- or 4-mm CAL Severe: ≥ 5mm CAL</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>RECESIION OF GINGIVAL MARGIN:</measure>
      <time_frame>15 days</time_frame>
      <description>Recession is measured from CEJ to margin of gingiva with the help of CPITN probe on baseline visit, 7th day and 15th day. Severity of disease is assessed as follows&#xD;
  CLASS I:&#xD;
  Marginal tissue recession that does not extend to the mucogingival junction. There is no loss of bone or soft tissue in the interdental area. This can be narrow or wide.&#xD;
  CLASS II:&#xD;
  Marginal tissue recession that extends to or beyond the mucogingival junction. There is no loss of bone or soft tissue in the interdental area. This can be narrow or wide.&#xD;
  CLASS III:&#xD;
  Marginal tissue recession that extends to or beyond the mucogingival junction. In addition, there is loss of bone and/or soft tissue in the interdental area or there is malpositioning of the tooth.&#xD;
  CLASS IV:&#xD;
  Marginal tissue recession that extends to or beyond the mucogingival junction with severe loss of bone and soft tissue interdentally and/or severe malpositioning of the tooth.</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Actual">380</enrollment>
    <condition>Periodontitis</condition>
    <condition>Diabetes Mellitus</condition>
    <arm_group>
      <arm_group_label>Scaling and root planning</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Once the patients fulfill the inclusion criteria and are randomly assigned to this group, they undergo scaling and root planning by the consultant. Baseline values are recorded, and patients are advised oral hygiene instructions i.e., proper brushing and flossing. They are recalled after 7 and 15 days and all clinical parameters are rerecorded.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Scaling and root planning plus metronidazole gel</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>After fulfilling the inclusion criteria and randomly assigning to this group, they undergo scaling and root planning by the consultant. Baseline values are recorded, and 1ml of 1% metronidazole gel is applied subgingivally. The patients are instructed not to spit or rinse for at least one hour. Then patients are advised oral hygiene instructions i.e., proper brushing and flossing. They are recalled after 7 and 15 days and all clinical parameters are rerecorded.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Scaling and root planning plus minocycline gel</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>After fulfilling the inclusion criteria and being randomly assigned to this group, the patients undergo scaling and root planning by the consultant. Baseline values are recorded, and 1ml of 2% minocycline gel is applied subgingivally. The patients are instructed not to spit or rinse for at least one hour. Then patients are advised oral hygiene instructions i.e., proper brushing and flossing. They are recalled after 7 and 15 days and all clinical parameters are rerecorded.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Scaling and root planning plus combination of metronidazole and minocycline gels</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>After fulfilling the inclusion criteria and being randomly assigned to this group, the patients undergo scaling and root planning by the consultant. Baseline values are recorded, 1ml of the combination of 1% metronidazole gel and 2% minocycline gel is applied subgingivally. The patients are instructed not to spit or rinse for at least one hour. Then patients are advised oral hygiene instructions i.e., proper brushing and flossing. They are recalled after 7 and 15 days and all clinical parameters are rerecorded.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>1ml of 1% metronidazole gel</intervention_name>
      <description>1ml of 1% metronidazole gel subgingivally at baseline visit</description>
      <arm_group_label>Scaling and root planning plus metronidazole gel</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>1ml of 2% minocycline gel</intervention_name>
      <description>1ml of 2% minocycline gel sub gingivally at baseline visit</description>
      <arm_group_label>Scaling and root planning plus minocycline gel</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>1ml of combination of 1% metronidazole gel and 2% minocycline</intervention_name>
      <description>1ml of the combination of 1% metronidazole gel and 2% minocycline subgingivally at baseline visit</description>
      <arm_group_label>Scaling and root planning plus combination of metronidazole and minocycline gels</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Previously diagnosed diabetic patients on either hypoglycemics or insulin therapy&#xD;
               suffering from periodontitis&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Pregnant or nursing mothers Patients with gestational diabetes Alcoholics Patients under&#xD;
          any anti-inflammatory or antibiotic drugs (daily for ˃7 consecutive days) within the last&#xD;
          two months of elimination before entering the study.&#xD;
  &#xD;
          Known allergy to minocycline, or metronidazole. Periodontal surgeries in the past Smoking&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Aeman Choudhary, BDS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Riphah International University, Rawalpindi</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Islamic International Medical Collège, IIMC</name>
        <address>
          <city>Rawalpindi</city>
          <state>Punjab</state>
          <zip>44000</zip>
          <country>Pakistan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 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 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Chronic periodontitis</keyword>
    <keyword>Minocycline gel</keyword>
    <keyword>Scaling and root planning</keyword>
    <keyword>Metronidazole gel</keyword>
    <keyword>Efficacy of local administration</keyword>
    <keyword>Diabetes mellitus</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Periodontitis</mesh_term>
      <mesh_term>Diabetes Mellitus</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Metronidazole</mesh_term>
      <mesh_term>Minocycline</mesh_term>
    </intervention_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/NCT06027151
  org study id: Riphah/IIMC/IRC/22/2070
  nct id: NCT06027151
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This clinical study randomized 380 diabetic chronic periodontitis patients into 4 groups:
        scaling and root planning alone (group I), scaling and root planning plus metronidazole gel
        (group II), scaling and root planning plus minocycline gel (group III), and scaling and root
        planning plus both metronidazole and minocycline gels (group IV). Periodontal measurements
        including probing depth, gingival color and texture, bleeding on probing, clinical attachment
        level, and recession were recorded at baseline, 7 days, and 15 days.
  It was a clinical trial with four arms. The research was carried out at the Pharmacology
        Department, IIMC Riphah University, Rawalpindi. The sample size was calculated to be 380
        using the prevalence of disease, z-score, and 5% margin of error. Written informed consent
        was obtained from the participants. The patients being treated for chronic periodontitis were
        randomly divided into four groups (I, II, III, and IV). Patients in Group I were subjected to
        Scaling and root planning alone. Group II patients were given metronidazole gel following
        Scaling and root planning. Minocycline gel was locally applied subsequent to scaling and root
        planning in Group III patients. The combination of metronidazole gel and minocycline gel was
        administered after Scaling and root planning in Group IV patients. Scaling and root planning
        of all the patients was done. Periodontal probing depth, the color of the gingiva, texture of
        the gingiva, bleeding on probing, clinical attachment level, and recession were recorded for
        each patient at baseline visit, after 7 days, and after 15 days to determine and compare the
        efficacy of local administration of drugs.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: single blind, patient was unaware of which drug they were administered. It was done by covering the syringes with colored tapes
  measure: PERIODONTAL POCKET DEPTH (PPD)
  time frame: 15 days
  description: Periodontal pocket depth was measured in mm using a WHO (CPITN) periodontal probe.
  Baseline periodontal probing depth was measured before application of drug. It was remeasured on 7th day and 15th day. Reduction in probing depth indicates improvement on follow up visits.
  measure: COLOR OF GINGIVA
  time frame: 15 days
  description: Color of gingiva is observed at baseline visit, on 7th day and 15th day. Healthy gingiva is coral pink in color while diseased gingiva is erythematous cyanotic.
  measure: TEXTURE OF GINGIVA
  time frame: 15 days
  description: Texture of gingiva is observed at baseline visit, on 7th day and 15th day. Healthy gingiva is matte and stippled. Diseased gingiva is smooth and shiny.
  measure: BLEEDING ON PROBING (BOP)
  time frame: 15 days
  description: It was determined whether the site was bleeding on probing or not. Bleeding on probing is observed on the baseline visit, 7th day, and 15th day. If the gingiva is not bleeding then it is considered as normal.
  measure: CLINICAL ATTACHMENT Level
  time frame: 15 days
  description: Distance from cementoenamel junction to depth of pocket is measured with the help of CPITN probe. Readings are taken on baseline visit, 7th day and 15th day. Severity index is as follows.
  Healthy gingiva- 0mm CAL Mild: 1- or 2-mm CAL Moderate: 3- or 4-mm CAL Severe: ≥ 5mm CAL
  measure: RECESIION OF GINGIVAL MARGIN:
  time frame: 15 days
  description: Recession is measured from CEJ to margin of gingiva with the help of CPITN probe on baseline visit, 7th day and 15th day. Severity of disease is assessed as follows
  CLASS I:
  Marginal tissue recession that does not extend to the mucogingival junction. There is no loss of bone or soft tissue in the interdental area. This can be narrow or wide.
  CLASS II:
  Marginal tissue recession that extends to or beyond the mucogingival junction. There is no loss of bone or soft tissue in the interdental area. This can be narrow or wide.
  CLASS III:
  Marginal tissue recession that extends to or beyond the mucogingival junction. In addition, there is loss of bone and/or soft tissue in the interdental area or there is malpositioning of the tooth.
  CLASS IV:
  Marginal tissue recession that extends to or beyond the mucogingival junction with severe loss of bone and soft tissue interdentally and/or severe malpositioning of the tooth.
  arm group label: Scaling and root planning
  arm group type: No Intervention
  description: Once the patients fulfill the inclusion criteria and are randomly assigned to this group, they undergo scaling and root planning by the consultant. Baseline values are recorded, and patients are advised oral hygiene instructions i.e., proper brushing and flossing. They are recalled after 7 and 15 days and all clinical parameters are rerecorded.
  arm group label: Scaling and root planning plus metronidazole gel
  arm group type: Experimental
  description: After fulfilling the inclusion criteria and randomly assigning to this group, they undergo scaling and root planning by the consultant. Baseline values are recorded, and 1ml of 1% metronidazole gel is applied subgingivally. The patients are instructed not to spit or rinse for at least one hour. Then patients are advised oral hygiene instructions i.e., proper brushing and flossing. They are recalled after 7 and 15 days and all clinical parameters are rerecorded.
  arm group label: Scaling and root planning plus minocycline gel
  arm group type: Experimental
  description: After fulfilling the inclusion criteria and being randomly assigned to this group, the patients undergo scaling and root planning by the consultant. Baseline values are recorded, and 1ml of 2% minocycline gel is applied subgingivally. The patients are instructed not to spit or rinse for at least one hour. Then patients are advised oral hygiene instructions i.e., proper brushing and flossing. They are recalled after 7 and 15 days and all clinical parameters are rerecorded.
  arm group label: Scaling and root planning plus combination of metronidazole and minocycline gels
  arm group type: Experimental
  description: After fulfilling the inclusion criteria and being randomly assigned to this group, the patients undergo scaling and root planning by the consultant. Baseline values are recorded, 1ml of the combination of 1% metronidazole gel and 2% minocycline gel is applied subgingivally. The patients are instructed not to spit or rinse for at least one hour. Then patients are advised oral hygiene instructions i.e., proper brushing and flossing. They are recalled after 7 and 15 days and all clinical parameters are rerecorded.
  intervention type: Drug
  intervention name: 1ml of 1% metronidazole gel
  description: 1ml of 1% metronidazole gel subgingivally at baseline visit
  arm group label: Scaling and root planning plus metronidazole gel
  intervention type: Drug
  intervention name: 1ml of 2% minocycline gel
  description: 1ml of 2% minocycline gel sub gingivally at baseline visit
  arm group label: Scaling and root planning plus minocycline gel
  intervention type: Drug
  intervention name: 1ml of combination of 1% metronidazole gel and 2% minocycline
  description: 1ml of the combination of 1% metronidazole gel and 2% minocycline subgingivally at baseline visit
  arm group label: Scaling and root planning plus combination of metronidazole and minocycline gels
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Aeman Choudhary, BDS
  role: Principal Investigator
  affiliation: Riphah International University, Rawalpindi
  facility: 
  country: Pakistan
  responsible party type: Sponsor
  mesh term: Periodontitis
  mesh term: Diabetes Mellitus
  mesh term: Metronidazole
  mesh term: Minocycline
  sharing ipd: No