<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/NCT03308019</url>
  </required_header>
  <id_info>
    <org_study_id>FR-17-87</org_study_id>
    <nct_id>NCT03308019</nct_id>
  </id_info>
  <brief_title>Adjunct Photodynamic Therapy in Chronic Periodontitis Among Cigarette-smokers.</brief_title>
  <official_title>Effectiveness of Scaling and Root Planing With and Without Adjunct Antimicrobial Photodynamic Therapy in the Treatment of Chronic Periodontitis Among Cigarette-smokers and Never-smokers: A Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Saud University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Saud University</source>
  <oversight_info>
    <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 study evaluates the efficacy of scaling and root planing with and without adjunct&#xD;
      antimicrobial photodynamic therapy (aPDT) in the treatment of chronic periodontitis (CP)&#xD;
      among cigarette-smokers and never-smokers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The following inclusion criteria were entailed: (a) Self-reported habitual cigarette-smokers;&#xD;
      (b) self-reported never-smokers; (c) patients with CP (presence of at least 30% sites with ≥&#xD;
      3 mm of CAL and PD ≥ 3 mm 18, 19 ). The exclusion criteria were as follows: (a) patients with&#xD;
      systemic diseases such as acquired immune deficiency syndrome/HIV and diabetes mellitus; (b)&#xD;
      habitual smokeless tobacco product and alcohol users; (c) third molars and fractured teeth&#xD;
      with embedded root remnants and edentulous individuals; (d) patients with misaligned teeth;&#xD;
      and (e) patients that reported to have used antibiotics, non-steroidal anti-inflammatory&#xD;
      drugs and/or steroids within the past 90 days.&#xD;
&#xD;
      Demographic information was collected using a questionnaire. Cigarette-smokers (group-1) and&#xD;
      never-smokers (group-2) with chronic periodontitis were included. Treatment wise, these&#xD;
      individuals were divided into two subgroups as follows: (a) SRP alone and (b) SRP with&#xD;
      adjunct aPDT. Periodontal parameters (plaque index [PI], bleeding on probing [BOP], clinical&#xD;
      attachment loss [CAL] and probing pocket depth ≥4mm [PD] were measured at baseline and at 1&#xD;
      month and 3 months' follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 16, 2016</start_date>
  <completion_date type="Actual">September 16, 2017</completion_date>
  <primary_completion_date type="Actual">July 2, 2017</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Probing depth</measure>
    <time_frame>3 months</time_frame>
    <description>Probing depth will be measured as the distance from the gingival margin to the location of the tip of the probe to the nearest millimeter. Pocket depth assessment was carried out at 6 sites per tooth for all teeth (disto-buccal, mid-buccal, mesio-buccal, mesio-lingual, mid-lingual and disto-lingual)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical attachment level gain</measure>
    <time_frame>3 months</time_frame>
    <description>Clinical attachment level gain will be calculated for each site as the sum of probing depth and gingival recession. The CAL was recorded at 6 sites per tooth for all teeth (disto-buccal, mid-buccal, mesio-buccal, mesio-lingual, mid-lingual and disto-lingual) except third molars.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plaque index</measure>
    <time_frame>3 months</time_frame>
    <description>Plaque index will be detected visually by running the probe at 4 sites per tooth (mesio-buccal, disto-buccal, mid-buccal and palatal/lingual) for absence or presence of plaque, based on dichotomous scoring system. The scores ranged as follows; 0 - No visible plaque&#xD;
1 - Visible plaque</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding on probing</measure>
    <time_frame>3 months</time_frame>
    <description>Bleeding on probing will be recorded at 4 sites per tooth (mesio-buccal, disto-buccal, mid-buccal, and palatal/lingual) for absence or presence of bleeding, based on dichotomous scoring system. The scores ranged as follows; 0 - No visible bleeding&#xD;
1 - Visible bleeding</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">83</enrollment>
  <condition>Chronic Periodontitis</condition>
  <condition>Smoking</condition>
  <arm_group>
    <arm_group_label>Adjunctive photodynamic therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will be given scaling and root planing (SRP) with adjunctive photodynamic therapy (aPDT)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dental scaling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm will be given scaling and root planing (SRP) only</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Photodynamic therapy</intervention_name>
    <description>In groups 1 and 2, aPDT was performed after SRP. The protocol for aPDT is described elsewhere. Briefly, using a blunt needle, 0.005% of Methylene blue was applied into the periodontal pocket and left in place for 10 seconds. The dye was then irradiated with a diode laser (670 nanometers) at 150 milliwatts. In each dye filled periodontal pocket, laser irradiation was performed for one minute using a flexible tip. In the present study, aPDT was performed once, at baseline, by a trained dentist.</description>
    <arm_group_label>Adjunctive photodynamic therapy</arm_group_label>
    <arm_group_label>Dental scaling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Scaling and root planing (SRP)</intervention_name>
    <description>In both groups, SRP was performed in one session under local anesthesia using handheld Gracey curettes No. 5/6. One trained dental hygienist blinded to the study groups and subgroups made 9 to 10 strokes in a vertical (apico-coronal) direction and the inclination between scaler tips and roots was maintained as zero. When the curved explorer indicated a smooth and hard dental surface, SRP was judged as completed. In all individuals, SRP was done in one session without any assigned time limit for completion.</description>
    <arm_group_label>Adjunctive photodynamic therapy</arm_group_label>
    <arm_group_label>Dental scaling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Self-reported habitual cigarette-smokers.&#xD;
&#xD;
          -  Self-reported never-smokers.&#xD;
&#xD;
          -  Patients with chronic periodontitis (presence of at least 30% sites with ≥ 3 mm of CAL&#xD;
             and PD ≥ 3 mm.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with systemic diseases such as acquired immune deficiency syndrome/HIV and&#xD;
             diabetes mellitus.&#xD;
&#xD;
          -  Habitual smokeless tobacco product and alcohol users.&#xD;
&#xD;
          -  Third molars and fractured teeth with embedded root remnants and edentulous&#xD;
             individuals.&#xD;
&#xD;
          -  Patients with misaligned teeth.&#xD;
&#xD;
          -  Patients that reported to have used antibiotics, non-steroidal anti-inflammatory drugs&#xD;
             and/or steroids within the past 90 days.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>42 Years</minimum_age>
    <maximum_age>52 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 3, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>October 6, 2017</last_update_submitted>
  <last_update_submitted_qc>October 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King Saud University</investigator_affiliation>
    <investigator_full_name>Zohaib Akram</investigator_full_name>
    <investigator_title>Director, Clinical Research</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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual participant data for all primary outcome measures will be made available</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data is available</ipd_time_frame>
  </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/NCT03308019
org study id: FR-17-87
nct id: NCT03308019
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study evaluates the efficacy of scaling and root planing with and without adjunct
      antimicrobial photodynamic therapy (aPDT) in the treatment of chronic periodontitis (CP)
      among cigarette-smokers and never-smokers.
The following inclusion criteria were entailed: (a) Self-reported habitual cigarette-smokers;
      (b) self-reported never-smokers; (c) patients with CP (presence of at least 30% sites with ≥
      3 mm of CAL and PD ≥ 3 mm 18, 19 ). The exclusion criteria were as follows: (a) patients with
      systemic diseases such as acquired immune deficiency syndrome/HIV and diabetes mellitus; (b)
      habitual smokeless tobacco product and alcohol users; (c) third molars and fractured teeth
      with embedded root remnants and edentulous individuals; (d) patients with misaligned teeth;
      and (e) patients that reported to have used antibiotics, non-steroidal anti-inflammatory
      drugs and/or steroids within the past 90 days.

      Demographic information was collected using a questionnaire. Cigarette-smokers (group-1) and
      never-smokers (group-2) with chronic periodontitis were included. Treatment wise, these
      individuals were divided into two subgroups as follows: (a) SRP alone and (b) SRP with
      adjunct aPDT. Periodontal parameters (plaque index [PI], bleeding on probing [BOP], clinical
      attachment loss [CAL] and probing pocket depth ≥4mm [PD] were measured at baseline and at 1
      month and 3 months' follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Probing depth
time frame: 3 months
description: Probing depth will be measured as the distance from the gingival margin to the location of the tip of the probe to the nearest millimeter. Pocket depth assessment was carried out at 6 sites per tooth for all teeth (disto-buccal, mid-buccal, mesio-buccal, mesio-lingual, mid-lingual and disto-lingual)
measure: Clinical attachment level gain
time frame: 3 months
description: Clinical attachment level gain will be calculated for each site as the sum of probing depth and gingival recession. The CAL was recorded at 6 sites per tooth for all teeth (disto-buccal, mid-buccal, mesio-buccal, mesio-lingual, mid-lingual and disto-lingual) except third molars.
measure: Plaque index
time frame: 3 months
description: Plaque index will be detected visually by running the probe at 4 sites per tooth (mesio-buccal, disto-buccal, mid-buccal and palatal/lingual) for absence or presence of plaque, based on dichotomous scoring system. The scores ranged as follows; 0 - No visible plaque
1 - Visible plaque
measure: Bleeding on probing
time frame: 3 months
description: Bleeding on probing will be recorded at 4 sites per tooth (mesio-buccal, disto-buccal, mid-buccal, and palatal/lingual) for absence or presence of bleeding, based on dichotomous scoring system. The scores ranged as follows; 0 - No visible bleeding
1 - Visible bleeding
arm group label: Adjunctive photodynamic therapy
arm group type: Experimental
description: This arm will be given scaling and root planing (SRP) with adjunctive photodynamic therapy (aPDT)
arm group label: Dental scaling
arm group type: Active Comparator
description: This arm will be given scaling and root planing (SRP) only
intervention type: Device
intervention name: Photodynamic therapy
description: In groups 1 and 2, aPDT was performed after SRP. The protocol for aPDT is described elsewhere. Briefly, using a blunt needle, 0.005% of Methylene blue was applied into the periodontal pocket and left in place for 10 seconds. The dye was then irradiated with a diode laser (670 nanometers) at 150 milliwatts. In each dye filled periodontal pocket, laser irradiation was performed for one minute using a flexible tip. In the present study, aPDT was performed once, at baseline, by a trained dentist.
arm group label: Adjunctive photodynamic therapy
arm group label: Dental scaling
intervention type: Procedure
intervention name: Scaling and root planing (SRP)
description: In both groups, SRP was performed in one session under local anesthesia using handheld Gracey curettes No. 5/6. One trained dental hygienist blinded to the study groups and subgroups made 9 to 10 strokes in a vertical (apico-coronal) direction and the inclination between scaler tips and roots was maintained as zero. When the curved explorer indicated a smooth and hard dental surface, SRP was judged as completed. In all individuals, SRP was done in one session without any assigned time limit for completion.
arm group label: Adjunctive photodynamic therapy
arm group label: Dental scaling
criteria: 
gender: Male
minimum age: 42 Years
maximum age: 52 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: King Saud University
investigator full name: Zohaib Akram
investigator title: Director, Clinical Research
mesh term: Periodontitis
mesh term: Chronic Periodontitis
sharing ipd: Yes
ipd description: De-identified individual participant data for all primary outcome measures will be made available
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Data is available