<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/NCT03764410</url>
  </required_header>
  <id_info>
    <org_study_id>SantosMU4</org_study_id>
    <nct_id>NCT03764410</nct_id>
  </id_info>
  <brief_title>Evaluation of Non - Surgical Periodontal Therapy in Diabetic Patients.</brief_title>
  <official_title>Evaluation of Periodontal Clinical Parameters and Blood Tests in Diabetic Patients Submitted to Non-surgical Periodontal Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Metropolitana de Santos</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Metropolitana de Santos</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>
      Unfavorable systemic conditions condition a low resistance of the host to the virulence of&#xD;
      the aggressive agent, causing in a periodontal disease and may lead to difficulties in the&#xD;
      therapeutic response. The longer the duration of diabetes, it is suggested that greater&#xD;
      severity of periodontal disease and loss of insertion. The objective of the present study&#xD;
      will be to evaluate the clinical, microbial and immunological characteristics in diabetic&#xD;
      subjects with chronic periodontitis submitted to non-surgical periodontal treatment. Will be&#xD;
      120 individuals with chronic periodontitis, including 60 type 2 diabetic subjects and 60&#xD;
      healthy should receive and have access to the informed consent form. Medical and dental&#xD;
      clinical examination should be performed and evaluation microbial and immunological&#xD;
      properties of gingival fluid and saliva respectively. Non-surgical periodontal therapy with&#xD;
      subgingival scaling should be performed in all individuals who will be evaluated at two&#xD;
      times: at the beginning and after 90 days of the periodontal therapy with new performing&#xD;
      clinical exams and collecting oral samples, oral hygiene instructions will be addressed in&#xD;
      two sessions. The data will be subjected to appropriate statistical tests and shall provide a&#xD;
      comparison between the times. There seems to be a relationship between type 2 diabetes and&#xD;
      periodontal disease and studies that provide the implementation of therapy are essential for&#xD;
      clarifying the relationship.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is a need for more intense metabolic control of the diabetic patient with periodontal&#xD;
      disease, since the destruction of the periodontal tissues may be more aggressive, and a rapid&#xD;
      control of the oral infection in these patients is essential to avoid the exacerbation of the&#xD;
      metabolic imbalance. The initiation and progression of diabetes probably involve the&#xD;
      interaction of a multiplicity of factors, these being hereditary and immunological factors&#xD;
      that are governed by environmental factors. It can be observed that there is a lack of&#xD;
      awareness of oral complications between diabetics and health care providers, and it is&#xD;
      extremely important to understand how diabetes affects oral health and there is a need for&#xD;
      regular follow-up of patients with diabetes mellitus by dentists and medical professional.&#xD;
      The objective of the present study was to evaluate diabetic individuals with chronic&#xD;
      periodontitis submitted to non-surgical periodontal treatment using clinical parameters and&#xD;
      blood tests of fasting glycemia and glycated hemoglobin. The study was approved by the&#xD;
      Research Committee of the Metropolitan University of Santos, nº 1.806.841 and all the&#xD;
      patients involved in the research had access to the informed consent form. The diagnosis of&#xD;
      diabetes was obtained through blood tests that test blood glucose levels, thus, before&#xD;
      clinical evaluations, and 90 days after the periodontal treatment were performed fasting&#xD;
      blood glucose tests. Healthy patients also underwent blood tests. After the anamnesis,&#xD;
      periodontal clinical examination was performed by a previously trained and calibrated&#xD;
      periodontist. Periodontal clinical parameters were realized. After periodontal therapy, all&#xD;
      patients underwent further periodontal and laboratory blood tests. The data obtained were&#xD;
      tabulated and received statistical treatment through the Anova and Chi square tests. There&#xD;
      seems to be a relationship between type 2 diabetes and periodontal disease and studies that&#xD;
      provide the implementation of therapy are essential for clarifying the relationship.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2016</start_date>
  <completion_date type="Actual">December 30, 2017</completion_date>
  <primary_completion_date type="Actual">October 15, 2017</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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>blood test fasting blood glucose</measure>
    <time_frame>90 days</time_frame>
    <description>blood tests were performed at baseline and 90 days after periodontal therapy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>blood test for glycated hemoglobin</measure>
    <time_frame>90 days</time_frame>
    <description>blood tests were performed at baseline and 90 days after periodontal therapy</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Periodontal Diseases</condition>
  <arm_group>
    <arm_group_label>Diabetic group DG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-surgical periodontal treatment with scaling and root coronary planing, oral hygiene instructions and removal of biofilm retention factors</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No diabetic group NG</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Non-surgical periodontal treatment with scaling and root coronary planing, oral hygiene instructions and removal of biofilm retention factors</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Non-surgical periodontal treatment</intervention_name>
    <description>all the individuals included in the study received periodontal treatment with scaling and root planing with the use of local anesthesia and removal of factors that could cause biofilm retention such as fixed prosthesis, restorations, cervical abrasions. Four weekly sessions lasting 30 minutes each.</description>
    <arm_group_label>Diabetic group DG</arm_group_label>
    <arm_group_label>No diabetic group NG</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diabetic patients with chronic periodontitis and Systemically healthy patients with&#xD;
             chronic periodontitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who had any of the following characteristics were excluded from the study:&#xD;
             use of orthodontic appliances, smoking, pregnancy or lactation, hepatitis or HIV&#xD;
             infection or any other disease that compromises immune functions, immunosuppressive&#xD;
             chemotherapy, antibiotics, phenytoin, calcium antagonists, cyclosporine or&#xD;
             anti-inflammatory drugs one month before the initial consultation, use of oral&#xD;
             contraceptives or hormone replacement, periodontal treatment in the 6 months prior to&#xD;
             the start of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>CAIO VINICIUS G ROMAN TORRES</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Santo Amaro</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Caio Vinicius Gonçalves Roman Torres</name>
      <address>
        <city>Santos</city>
        <state>SP</state>
        <zip>11015001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Izuora K, Ezeanolue E, Schlauch K, Neubauer M, Gewelber C, Umpierrez G. Impact of periodontal disease on outcomes in diabetes. Contemp Clin Trials. 2015 Mar;41:93-9. doi: 10.1016/j.cct.2015.01.011. Epub 2015 Jan 24.</citation>
    <PMID>25623292</PMID>
  </reference>
  <results_reference>
    <citation>Simpson TC, Weldon JC, Worthington HV, Needleman I, Wild SH, Moles DR, Stevenson B, Furness S, Iheozor-Ejiofor Z. Treatment of periodontal disease for glycaemic control in people with diabetes mellitus. Cochrane Database Syst Rev. 2015 Nov 6;2015(11):CD004714. doi: 10.1002/14651858.CD004714.pub3.</citation>
    <PMID>26545069</PMID>
  </results_reference>
  <results_reference>
    <citation>Wang X, Han X, Guo X, Luo X, Wang D. The effect of periodontal treatment on hemoglobin a1c levels of diabetic patients: a systematic review and meta-analysis. PLoS One. 2014 Sep 25;9(9):e108412. doi: 10.1371/journal.pone.0108412. eCollection 2014.</citation>
    <PMID>25255331</PMID>
  </results_reference>
  <results_reference>
    <citation>Pranckeviciene A, Siudikiene J, Ostrauskas R, Machiulskiene V. Long-term effect of periodontal surgery on oral health and metabolic control of diabetics. Clin Oral Investig. 2017 Apr;21(3):735-743. doi: 10.1007/s00784-016-1819-y. Epub 2016 Apr 11.</citation>
    <PMID>27068410</PMID>
  </results_reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>January 23, 2020</last_update_submitted>
  <last_update_submitted_qc>January 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Metropolitana de Santos</investigator_affiliation>
    <investigator_full_name>CAIO VINICIUS G. ROMAN TORRES</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Diabetes mellitus, periodontal diseases, periodontal index</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontal Diseases</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>the data obtained must be presented in manuscript form to be published in a specialized journal of the area</ipd_description>
  </patient_data>
  <!-- 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/NCT03764410
org study id: SantosMU4
nct id: NCT03764410
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Unfavorable systemic conditions condition a low resistance of the host to the virulence of
      the aggressive agent, causing in a periodontal disease and may lead to difficulties in the
      therapeutic response. The longer the duration of diabetes, it is suggested that greater
      severity of periodontal disease and loss of insertion. The objective of the present study
      will be to evaluate the clinical, microbial and immunological characteristics in diabetic
      subjects with chronic periodontitis submitted to non-surgical periodontal treatment. Will be
      120 individuals with chronic periodontitis, including 60 type 2 diabetic subjects and 60
      healthy should receive and have access to the informed consent form. Medical and dental
      clinical examination should be performed and evaluation microbial and immunological
      properties of gingival fluid and saliva respectively. Non-surgical periodontal therapy with
      subgingival scaling should be performed in all individuals who will be evaluated at two
      times: at the beginning and after 90 days of the periodontal therapy with new performing
      clinical exams and collecting oral samples, oral hygiene instructions will be addressed in
      two sessions. The data will be subjected to appropriate statistical tests and shall provide a
      comparison between the times. There seems to be a relationship between type 2 diabetes and
      periodontal disease and studies that provide the implementation of therapy are essential for
      clarifying the relationship.
There is a need for more intense metabolic control of the diabetic patient with periodontal
      disease, since the destruction of the periodontal tissues may be more aggressive, and a rapid
      control of the oral infection in these patients is essential to avoid the exacerbation of the
      metabolic imbalance. The initiation and progression of diabetes probably involve the
      interaction of a multiplicity of factors, these being hereditary and immunological factors
      that are governed by environmental factors. It can be observed that there is a lack of
      awareness of oral complications between diabetics and health care providers, and it is
      extremely important to understand how diabetes affects oral health and there is a need for
      regular follow-up of patients with diabetes mellitus by dentists and medical professional.
      The objective of the present study was to evaluate diabetic individuals with chronic
      periodontitis submitted to non-surgical periodontal treatment using clinical parameters and
      blood tests of fasting glycemia and glycated hemoglobin. The study was approved by the
      Research Committee of the Metropolitan University of Santos, nº 1.806.841 and all the
      patients involved in the research had access to the informed consent form. The diagnosis of
      diabetes was obtained through blood tests that test blood glucose levels, thus, before
      clinical evaluations, and 90 days after the periodontal treatment were performed fasting
      blood glucose tests. Healthy patients also underwent blood tests. After the anamnesis,
      periodontal clinical examination was performed by a previously trained and calibrated
      periodontist. Periodontal clinical parameters were realized. After periodontal therapy, all
      patients underwent further periodontal and laboratory blood tests. The data obtained were
      tabulated and received statistical treatment through the Anova and Chi square tests. There
      seems to be a relationship between type 2 diabetes and periodontal disease and studies that
      provide the implementation of therapy are essential for clarifying the relationship.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: blood test fasting blood glucose
time frame: 90 days
description: blood tests were performed at baseline and 90 days after periodontal therapy
measure: blood test for glycated hemoglobin
time frame: 90 days
description: blood tests were performed at baseline and 90 days after periodontal therapy
arm group label: Diabetic group DG
arm group type: Experimental
description: Non-surgical periodontal treatment with scaling and root coronary planing, oral hygiene instructions and removal of biofilm retention factors
arm group label: No diabetic group NG
arm group type: Active Comparator
description: Non-surgical periodontal treatment with scaling and root coronary planing, oral hygiene instructions and removal of biofilm retention factors
intervention type: Procedure
intervention name: Non-surgical periodontal treatment
description: all the individuals included in the study received periodontal treatment with scaling and root planing with the use of local anesthesia and removal of factors that could cause biofilm retention such as fixed prosthesis, restorations, cervical abrasions. Four weekly sessions lasting 30 minutes each.
arm group label: Diabetic group DG
arm group label: No diabetic group NG
criteria: 
gender: All
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: CAIO VINICIUS G ROMAN TORRES
role: Principal Investigator
affiliation: University of Santo Amaro
facility: 
country: Brazil
citation: Izuora K, Ezeanolue E, Schlauch K, Neubauer M, Gewelber C, Umpierrez G. Impact of periodontal disease on outcomes in diabetes. Contemp Clin Trials. 2015 Mar;41:93-9. doi: 10.1016/j.cct.2015.01.011. Epub 2015 Jan 24.
PMID: 25623292
citation: Simpson TC, Weldon JC, Worthington HV, Needleman I, Wild SH, Moles DR, Stevenson B, Furness S, Iheozor-Ejiofor Z. Treatment of periodontal disease for glycaemic control in people with diabetes mellitus. Cochrane Database Syst Rev. 2015 Nov 6;2015(11):CD004714. doi: 10.1002/14651858.CD004714.pub3.
PMID: 26545069
citation: Wang X, Han X, Guo X, Luo X, Wang D. The effect of periodontal treatment on hemoglobin a1c levels of diabetic patients: a systematic review and meta-analysis. PLoS One. 2014 Sep 25;9(9):e108412. doi: 10.1371/journal.pone.0108412. eCollection 2014.
PMID: 25255331
citation: Pranckeviciene A, Siudikiene J, Ostrauskas R, Machiulskiene V. Long-term effect of periodontal surgery on oral health and metabolic control of diabetics. Clin Oral Investig. 2017 Apr;21(3):735-743. doi: 10.1007/s00784-016-1819-y. Epub 2016 Apr 11.
PMID: 27068410
responsible party type: Principal Investigator
investigator affiliation: Universidade Metropolitana de Santos
investigator full name: CAIO VINICIUS G. ROMAN TORRES
investigator title: Professor
mesh term: Periodontal Diseases
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No
ipd description: the data obtained must be presented in manuscript form to be published in a specialized journal of the area