<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/NCT03265821</url>
  </required_header>
  <id_info>
    <org_study_id>Smoking periodontal healing</org_study_id>
    <nct_id>NCT03265821</nct_id>
  </id_info>
  <brief_title>Influence of Smoking on Periodontal Healing One Year After Active Treatment</brief_title>
  <official_title>Influence of Smoking on Periodontal Healing One Year After Active Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dalarna County Council, Sweden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dalarna County Council, Sweden</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to investigate whether cigarette smoking had any impact on the&#xD;
      clinical outcomes 1 year after active periodontal treatment. Eligible for the study were 5680&#xD;
      individuals 20-85 years, referred to the specialised clinic for periodontal treatment at&#xD;
      Gävle County Hospital between the years of 1980 and 2015. Before examination, all individuals&#xD;
      filled in a questionnaire regarding their medical health, medication and smoking habits.&#xD;
&#xD;
      Excluded were edentulous individuals and where clinical data 1-year after active treatment,&#xD;
      or smoking habits were missing (n=1453). Complete data for analyses was available for 4227&#xD;
      individuals.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Probing pocket depth</measure>
    <time_frame>1 year</time_frame>
    <description>Probing pocket depth</description>
  </primary_outcome>
  <enrollment type="Actual">4227</enrollment>
  <condition>Periodontal Diseases</condition>
  <condition>Smoking</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Healing after treatment</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals 20-85 years, referred to the specialised clinic for periodontal treatment at&#xD;
        Gavle County Hospital, Sweden between the years of 1980 and 2015.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals referred to a specialist clinic for periodontal treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  edentulous individuals&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>June 27, 2023</last_update_submitted>
  <last_update_submitted_qc>June 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dalarna County Council, Sweden</investigator_affiliation>
    <investigator_full_name>Kristina Edman</investigator_full_name>
    <investigator_title>Reg dental hygienist, medical doctor</investigator_title>
  </responsible_party>
  <keyword>Smoking</keyword>
  <keyword>Periodontal treatment</keyword>
  <keyword>Periodontal disease</keyword>
  <keyword>Healing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontal Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT03265821
org study id: Smoking periodontal healing
nct id: NCT03265821
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to investigate whether cigarette smoking had any impact on the
      clinical outcomes 1 year after active periodontal treatment. Eligible for the study were 5680
      individuals 20-85 years, referred to the specialised clinic for periodontal treatment at
      Gävle County Hospital between the years of 1980 and 2015. Before examination, all individuals
      filled in a questionnaire regarding their medical health, medication and smoking habits.

      Excluded were edentulous individuals and where clinical data 1-year after active treatment,
      or smoking habits were missing (n=1453). Complete data for analyses was available for 4227
      individuals.
observational model: Cohort
time perspective: Retrospective
measure: Probing pocket depth
time frame: 1 year
description: Probing pocket depth
intervention type: Procedure
intervention name: Healing after treatment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Dalarna County Council, Sweden
investigator full name: Kristina Edman
investigator title: Reg dental hygienist, medical doctor
mesh term: Periodontal Diseases