<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/NCT03783845</url>
  </required_header>
  <id_info>
    <org_study_id>periodontal therapy and HbA1c</org_study_id>
    <nct_id>NCT03783845</nct_id>
  </id_info>
  <brief_title>The Effects of Periodontal Therapy on Glycemic Control in Diabetic Patients</brief_title>
  <official_title>The Effects of Non -Surgical Periodontal Therapy on Glycemic Control and Periodontal Health in Diabetic Patients With Periodontitis (Randomized Controlled Clinical Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taibah University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taibah 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>
      Is the non-surgical periodontal therapy can improve glycemic control in type 2 diabetic&#xD;
      patients with chronic periodontitis?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the present study was to monitor the clinical outcomes and the metabolic response&#xD;
      of non-surgical periodontal therapy in patients with chronic periodontitis and uncontrolled&#xD;
      type 2 diabetes.&#xD;
&#xD;
      Regarding clinical and metabolic parameters at baseline, no differences were displayed&#xD;
      between two groups. However, at 3-months follow-up period the patients within a test group&#xD;
      were demonstrated better clinical outcomes than patients in a control group&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2015</start_date>
  <completion_date type="Actual">March 30, 2016</completion_date>
  <primary_completion_date type="Actual">March 1, 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>glycosylated haemoglobin (HbA1c)</measure>
    <time_frame>3 months</time_frame>
    <description>Blood was taken from a peripheral vein to monitor HbA1c using high-performance liquid chromatography</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Chronic Periodontitis, Generalized</condition>
  <arm_group>
    <arm_group_label>test group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Metronidazole 400mg,three times daily for two weeks&#xD;
Amoxicillin 500mg,three times daily for two weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>no intervention during study period</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>amoxicillin 500mg and metronidazole 400mg</intervention_name>
    <description>metronidazole 400mg and amoxicillin 500mg three times daily for two weeks</description>
    <arm_group_label>test group</arm_group_label>
    <other_name>Amoxil and Flagyl</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Diagnosis of diabetes type 2 for more than five years Type 2 diabetes with HbA1c level from&#xD;
        7% to 9% at the last medical evaluation Diagnosis with chronic periodontitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Pregnancy&#xD;
&#xD;
          -  Alcoholism and smoking&#xD;
&#xD;
          -  Presence of any systemic disorders other than hypertension and diabetes&#xD;
&#xD;
          -  Diabetic major complications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>October 17, 2019</last_update_submitted>
  <last_update_submitted_qc>October 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taibah University</investigator_affiliation>
    <investigator_full_name>Yasser El Makaky</investigator_full_name>
    <investigator_title>Associated professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Chronic Periodontitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amoxicillin</mesh_term>
    <mesh_term>Metronidazole</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 11, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT03783845/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03783845
org study id: periodontal therapy and HbA1c
nct id: NCT03783845
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Is the non-surgical periodontal therapy can improve glycemic control in type 2 diabetic
      patients with chronic periodontitis?
The aim of the present study was to monitor the clinical outcomes and the metabolic response
      of non-surgical periodontal therapy in patients with chronic periodontitis and uncontrolled
      type 2 diabetes.

      Regarding clinical and metabolic parameters at baseline, no differences were displayed
      between two groups. However, at 3-months follow-up period the patients within a test group
      were demonstrated better clinical outcomes than patients in a control group
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: glycosylated haemoglobin (HbA1c)
time frame: 3 months
description: Blood was taken from a peripheral vein to monitor HbA1c using high-performance liquid chromatography
arm group label: test group
arm group type: Experimental
description: Metronidazole 400mg,three times daily for two weeks
Amoxicillin 500mg,three times daily for two weeks.
arm group label: control group
arm group type: No Intervention
description: no intervention during study period
intervention type: Combination Product
intervention name: amoxicillin 500mg and metronidazole 400mg
description: metronidazole 400mg and amoxicillin 500mg three times daily for two weeks
arm group label: test group
other name: Amoxil and Flagyl
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Taibah University
investigator full name: Yasser El Makaky
investigator title: Associated professor
mesh term: Periodontitis
mesh term: Chronic Periodontitis
mesh term: Amoxicillin
mesh term: Metronidazole
provided document: 