<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/NCT03749369</url>
  </required_header>
  <id_info>
    <org_study_id>ZCD</org_study_id>
    <nct_id>NCT03749369</nct_id>
  </id_info>
  <brief_title>Adjunctive Use of Salvadora Persica in Chronic Periodontitis</brief_title>
  <official_title>Effect of Salvadora Persica on Clinical, Radiographic and Microbiological Parameters of Chronic Periodontitis: A Triple-Blind Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Saud University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ziauddin University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized controlled triple blinded study to evaluate the effectiveness of Salvadora&#xD;
      Persic (SP) as an adjunct to Scaling and Root Planing (SRP) in chronic periodontitis by&#xD;
      comparing the basic parameters of periodontitis, radiographs and bacterial levels with a&#xD;
      controlled group (SRP only).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sixty-six subjects with untreated, moderate-to-severe chronic periodontitis will be selected&#xD;
      by convenience sampling. The participants will be randomly divided into 2 groups:&#xD;
&#xD;
        1. Test group: SRP + SP gel&#xD;
&#xD;
        2. Control group: SRP only&#xD;
&#xD;
      Each participant will undergo treatment in the following steps:&#xD;
&#xD;
        1. QUESTIONNAIRE:&#xD;
&#xD;
           All participants will complete a structured baseline questionnaire provided by one&#xD;
           trained interviewer that will include the data regarding; (a) age; (2) gender; (3)&#xD;
           education status; (4) occupation; (5) medical status&#xD;
&#xD;
        2. INFORMED CONSENT:&#xD;
&#xD;
           All eligible subjects will be thoroughly informed of the nature, potential risks and&#xD;
           benefits of their participation in the study.&#xD;
&#xD;
        3. ASSESSMENT OF PARAMETERS:&#xD;
&#xD;
             1. CLINICAL PERIODONTAL PARAMETERS Full-mouth plaque index (PI), bleeding on probing&#xD;
                (BOP), probing depth (PD), and clinical attachment loss (CAL) will be recorded on&#xD;
                baseline, 6th week and 12th week for all the patients that pass the inclusion&#xD;
                criteria.&#xD;
&#xD;
             2. RADIOGRAPHIC ANALYSIS The depth of bony defects (BD) will be evaluated at baseline,&#xD;
                6 and 12 weeks using image analysis software (Scion Image Analyzer, Scion,&#xD;
                Frederick, MD, USA).&#xD;
&#xD;
             3. ANALYSIS OF PLAQUE MICROORGANISM Subgingival plaque will be collected at baseline&#xD;
                and 12 weeks from the deepest PD (&gt;4mm) of each patient.&#xD;
&#xD;
        4. SCALING AND ROOT PLANING After baseline recordings, thorough SRP will be performed by a&#xD;
           single clinician. The SRP procedure will be carried out in two sittings, comprising of&#xD;
           ultrasonic scaling in the first, and manual instrumentation and root debridement in the&#xD;
           second.&#xD;
&#xD;
        5. APPLICATION OF SP GEL In the test group, areas with PPD greater than 4 mm will be marked&#xD;
           on the periodontal chart. In these areas SP gel will be placed following root planing&#xD;
           procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">April 1, 2019</start_date>
  <completion_date type="Anticipated">October 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2019</primary_completion_date>
  <phase>Early Phase 1</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>clinical attachment level</measure>
    <time_frame>3 months</time_frame>
    <description>Clinical attachment level (CAL) is the distance from the cemento-enamel junction to the base of the sulcus. It will be measured by a calibrated examiner who will use a UNC 15 probe at 6 points around each tooth. The measurements will be expressed as the nearest millimeters and will be entered into the advanced periodontal chart.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>periodontal pocket depth</measure>
    <time_frame>3 months</time_frame>
    <description>Probing depth (PD) is defined as the distance from the gingival margin to the base of the pocket/sulcus.It will be measured by a calibrated examiner, using a UNC 15 probe and expressed in millimetres. The value will be entered into the periodontal chart provided with the questionnaire.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>bleeding on probing</measure>
    <time_frame>3 months</time_frame>
    <description>presence or absence of bleeding on probing within 10 seconds around 6 points along each tooth. Presence of bleeding will be marked as 1, while absence will be marked as 0.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>plaque index</measure>
    <time_frame>3 months</time_frame>
    <description>presence of absence of plaque along 6 points around each tooth will be examined and entered in the periodontal chart. SItes showing plaque will be marked as 1, while those not showing plaque will be marked as 0.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>intrabony defects</measure>
    <time_frame>3 months</time_frame>
    <description>Bony defects will be measured on the radiograph by measuring the distance from the cemento-enamel junction to the crest of the bone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Porphyramonas gingivalis level</measure>
    <time_frame>3 months</time_frame>
    <description>assessment of porphyromona ginivalis levels will be done utilising the Real-time Polymerase Chain Reaction (PCR) at baseline and 3 months.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">66</enrollment>
  <condition>Chronic Periodontitis</condition>
  <arm_group>
    <arm_group_label>SRP plus salvadora persica root</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects receiving salvadora gel in addition to scaling and root planing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SRP only</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects receiving scaling and root planing only</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Salvadora Persica Root</intervention_name>
    <description>Salvadora Persica Gel</description>
    <arm_group_label>SRP plus salvadora persica root</arm_group_label>
    <other_name>SP gel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Scaling and root planing</intervention_name>
    <description>Thorough scaling and root planing (SRP) will be performed by a single clinician. The SRP procedure will be carried out in two sittings, comprising of ultrasonic scaling in the first, and manual instrumentation and root debridement in the second.</description>
    <arm_group_label>SRP only</arm_group_label>
    <arm_group_label>SRP plus salvadora persica root</arm_group_label>
    <other_name>SRP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects who are &gt;30 years old&#xD;
&#xD;
          2. Minimum of 20 teeth , excluding third molars&#xD;
&#xD;
          3. Systemically healthy patients with moderate (PD of 5 to 6 mm or clinical attachment&#xD;
             loss CAL of 4 to 6 mm) or deep pockets (PD ≥7mm or CAL of 6 to 9 mm) and vertical bone&#xD;
             loss ≥3 mm on intraoral periapical radiographs (Armitage 1999)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of systemic conditions that could modify the progression of periodontitis&#xD;
             such as diabetes mellitus, metabolic syndrome, cardiovascular disease or immunologic&#xD;
             disorders&#xD;
&#xD;
          2. Systemic antimicrobials in the previous 6 months&#xD;
&#xD;
          3. Aggressive periodontitis&#xD;
&#xD;
          4. Pregnancy or lactation&#xD;
&#xD;
          5. Inability to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Zohaib Akram, MSc</last_name>
    <phone>00923343644615</phone>
    <email>drzohaibakram@gmail.com</email>
  </overall_contact>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>February 28, 2019</last_update_submitted>
  <last_update_submitted_qc>February 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2019</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>Senior Registrar</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>Undecided</sharing_ipd>
  </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/NCT03749369
org study id: ZCD
nct id: NCT03749369
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
A randomized controlled triple blinded study to evaluate the effectiveness of Salvadora
      Persic (SP) as an adjunct to Scaling and Root Planing (SRP) in chronic periodontitis by
      comparing the basic parameters of periodontitis, radiographs and bacterial levels with a
      controlled group (SRP only).
Sixty-six subjects with untreated, moderate-to-severe chronic periodontitis will be selected
      by convenience sampling. The participants will be randomly divided into 2 groups:

        1. Test group: SRP + SP gel

        2. Control group: SRP only

      Each participant will undergo treatment in the following steps:

        1. QUESTIONNAIRE:

           All participants will complete a structured baseline questionnaire provided by one
           trained interviewer that will include the data regarding; (a) age; (2) gender; (3)
           education status; (4) occupation; (5) medical status

        2. INFORMED CONSENT:

           All eligible subjects will be thoroughly informed of the nature, potential risks and
           benefits of their participation in the study.

        3. ASSESSMENT OF PARAMETERS:

             1. CLINICAL PERIODONTAL PARAMETERS Full-mouth plaque index (PI), bleeding on probing
                (BOP), probing depth (PD), and clinical attachment loss (CAL) will be recorded on
                baseline, 6th week and 12th week for all the patients that pass the inclusion
                criteria.

             2. RADIOGRAPHIC ANALYSIS The depth of bony defects (BD) will be evaluated at baseline,
                6 and 12 weeks using image analysis software (Scion Image Analyzer, Scion,
                Frederick, MD, USA).

             3. ANALYSIS OF PLAQUE MICROORGANISM Subgingival plaque will be collected at baseline
                and 12 weeks from the deepest PD (>4mm) of each patient.

        4. SCALING AND ROOT PLANING After baseline recordings, thorough SRP will be performed by a
           single clinician. The SRP procedure will be carried out in two sittings, comprising of
           ultrasonic scaling in the first, and manual instrumentation and root debridement in the
           second.

        5. APPLICATION OF SP GEL In the test group, areas with PPD greater than 4 mm will be marked
           on the periodontal chart. In these areas SP gel will be placed following root planing
           procedure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: clinical attachment level
time frame: 3 months
description: Clinical attachment level (CAL) is the distance from the cemento-enamel junction to the base of the sulcus. It will be measured by a calibrated examiner who will use a UNC 15 probe at 6 points around each tooth. The measurements will be expressed as the nearest millimeters and will be entered into the advanced periodontal chart.
measure: periodontal pocket depth
time frame: 3 months
description: Probing depth (PD) is defined as the distance from the gingival margin to the base of the pocket/sulcus.It will be measured by a calibrated examiner, using a UNC 15 probe and expressed in millimetres. The value will be entered into the periodontal chart provided with the questionnaire.
measure: bleeding on probing
time frame: 3 months
description: presence or absence of bleeding on probing within 10 seconds around 6 points along each tooth. Presence of bleeding will be marked as 1, while absence will be marked as 0.
measure: plaque index
time frame: 3 months
description: presence of absence of plaque along 6 points around each tooth will be examined and entered in the periodontal chart. SItes showing plaque will be marked as 1, while those not showing plaque will be marked as 0.
measure: intrabony defects
time frame: 3 months
description: Bony defects will be measured on the radiograph by measuring the distance from the cemento-enamel junction to the crest of the bone.
measure: Porphyramonas gingivalis level
time frame: 3 months
description: assessment of porphyromona ginivalis levels will be done utilising the Real-time Polymerase Chain Reaction (PCR) at baseline and 3 months.
arm group label: SRP plus salvadora persica root
arm group type: Active Comparator
description: Subjects receiving salvadora gel in addition to scaling and root planing
arm group label: SRP only
arm group type: Placebo Comparator
description: Subjects receiving scaling and root planing only
intervention type: Drug
intervention name: Salvadora Persica Root
description: Salvadora Persica Gel
arm group label: SRP plus salvadora persica root
other name: SP gel
intervention type: Procedure
intervention name: Scaling and root planing
description: Thorough scaling and root planing (SRP) will be performed by a single clinician. The SRP procedure will be carried out in two sittings, comprising of ultrasonic scaling in the first, and manual instrumentation and root debridement in the second.
arm group label: SRP only
arm group label: SRP plus salvadora persica root
other name: SRP
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Zohaib Akram, MSc
phone: 00923343644615
email: drzohaibakram@gmail.com
responsible party type: Principal Investigator
investigator affiliation: King Saud University
investigator full name: Zohaib Akram
investigator title: Senior Registrar
mesh term: Periodontitis
mesh term: Chronic Periodontitis
sharing ipd: Undecided