<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/NCT03270280</url>
  </required_header>
  <id_info>
    <org_study_id>UniversityHSL</org_study_id>
    <nct_id>NCT03270280</nct_id>
  </id_info>
  <brief_title>Comparison of Salivary Interleukin-1β and Matrix Metalloproteinase-8 Levels in Individuals With Chronic Periodontitis</brief_title>
  <official_title>Comparison of Salivary Interleukin-1β and Matrix Metalloproteinase-8 Levels in Individuals With Chronic Periodontitis Before and After Treatment With Nigella Sativa (Kalonji) Oil</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Health Sciences Lahore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Health Sciences Lahore</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Periodontitis is an infectious inflammatory disease affecting the periodontal tissue&#xD;
      (Gingivae, alveolar bone, periodontal ligament and cementum). Chronic Periodontitis is&#xD;
      considered to be the most prevalent disease after dental caries which is linked to increased&#xD;
      levels of C- reactive protein, interleukins and matrix metallo-proteinases. Interleukin- 1β&#xD;
      and Matrix metalloproteinase-8 have been shown to be robust markers of inflammatory cascade&#xD;
      of chronic periodontitis.Various treatment modalities including scaling and root planing,&#xD;
      toothpastes and chlorhexidine based mouthwashes have been are known to be associated with&#xD;
      various side effects like teeth staining, altered taste sensation, mucosal burning. Hence,the&#xD;
      use of natural medicaments could provide a better alternative because of their fewer side&#xD;
      effects and cost effectiveness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Periodontal disease is one of the most common diseases in humans and is responsible for most&#xD;
      of the tooth loss in adults. World health Organisation report of 2005 described that the&#xD;
      global problem persisted with the worldwide oral diseases such as dental caries, periodontal&#xD;
      disease, tooth loss, oral mucosal lesions and oro-pharyngeal cancer. According to a local&#xD;
      study the prevalence of periodontitis is found to be more in males of older age group and&#xD;
      more in rural areas owing to the lack of awareness of importance of oral hygiene.&#xD;
&#xD;
      Apart from various conventional treatment option for periodontitis a number of herbal&#xD;
      medicinal intervention have been used for its treatment. Plant extracts and herbs that have&#xD;
      been used previously used for periodontal therapy include Salvadora persica, Arnica Montana&#xD;
      and Hamamelis virginiana which have been shown to exhibit antibacterial activity against&#xD;
      periodonto-pathic bacteria. Phytomedicines (Medicines derived from herbal plants) like indian&#xD;
      gum arabic, aloe vera, nim, carvacrol, garlic, wild coffee and propolis resin have been used&#xD;
      in dentistry as anti-inflammatory, antibiotics, analgesic and hypnotic agents. Propolis&#xD;
      resin, guava and triphala have been also been used for the treatment of periodontitis&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 11, 2017</start_date>
  <completion_date type="Anticipated">April 11, 2018</completion_date>
  <primary_completion_date type="Anticipated">March 11, 2018</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>Healthy Individuals with Chronic Periodontitis Only</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Triple Blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Levels of IL 1-Beta and MMP-8</measure>
    <time_frame>2 weeks</time_frame>
    <description>These inflammatory marker will be measured in patients saliva again after 2 weeks. There will be reduction in their levels.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Chronic Periodontitis</condition>
  <arm_group>
    <arm_group_label>Normal Saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The group contains healthy individuals with chronic periodontitis who will receive Normal Saline as placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nigella Sativa</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The group contains healthy individuals with chronic periodontitis who will receive Nigella sativa Oil as intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nigella Sativa Oil</intervention_name>
    <description>The individuals will apply 55 drops of Nigella sativa Oil on gingivae twice daily for two weeks</description>
    <arm_group_label>Nigella Sativa</arm_group_label>
    <other_name>Black seed Oil</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>The individuals will apply 55 drops of Normal saline on gingivae twice daily for two weeks</description>
    <arm_group_label>Normal Saline</arm_group_label>
    <other_name>Saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female healthy individual&#xD;
&#xD;
          -  Individuals diagnosed with chronic periodontitis according to the WHO criteria.&#xD;
&#xD;
          -  Age 19 to 40 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with gingivitis only.&#xD;
&#xD;
          -  Patients using tobacco products and alcohol.&#xD;
&#xD;
          -  Underlying systemic pathology such as diabetes mellitus, cardiovascular disease,&#xD;
             arthritis etc.&#xD;
&#xD;
          -  Oral mucosal pre-neoplastic lesions (leukoplakia, erthroplakia, lichen planus) and&#xD;
             oral carcinomas.&#xD;
&#xD;
          -  Obese patients.&#xD;
&#xD;
          -  Pregnant females.&#xD;
&#xD;
          -  Xerostomia.&#xD;
&#xD;
          -  Previous history of radiotherapy or chemotherapy.&#xD;
&#xD;
          -  Positive history of oral prophylactic procedures (mouthwashes and antibiotics).&#xD;
&#xD;
          -  Positive history of any periodontal treatment during last 6 months.&#xD;
&#xD;
          -  Positive antibiotic therapy history within last month of study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ghazala Hassan, MPhil</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research Scholar</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ghazala Hassan, MPhil</last_name>
    <phone>+92 320 4635693</phone>
    <email>mashal_18@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sarah Ghafoor, PhD</last_name>
    <phone>+92 324 4787457</phone>
    <email>sarahghafoor@uhs.edu.pk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fatima Memorial Hospital</name>
      <address>
        <city>Lahore</city>
        <state>Punjab</state>
        <zip>0092</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <reference>
    <citation>Zadik Y, Bechor R, Galor S, Levin L. Periodontal disease might be associated even with impaired fasting glucose. Br Dent J. 2010 May 22;208(10):E20. doi: 10.1038/sj.bdj.2010.291. Epub 2010 Mar 26.</citation>
    <PMID>20339371</PMID>
  </reference>
  <reference>
    <citation>Gupta N, Gupta ND, Gupta A, Khan S, Bansal N. Role of salivary matrix metalloproteinase-8 (MMP-8) in chronic periodontitis diagnosis. Front Med. 2015 Mar;9(1):72-6. doi: 10.1007/s11684-014-0347-x. Epub 2014 Aug 6.</citation>
    <PMID>25098434</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>August 31, 2017</last_update_submitted>
  <last_update_submitted_qc>August 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Health Sciences Lahore</investigator_affiliation>
    <investigator_full_name>Dr. Ghazala Hassan</investigator_full_name>
    <investigator_title>Research Scholar</investigator_title>
  </responsible_party>
  <keyword>Chronic Periodontitis</keyword>
  <keyword>Phytomedicines</keyword>
  <keyword>Nigella sativa</keyword>
  <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>No</sharing_ipd>
    <ipd_description>Data sharing will be considered after the completion of studies</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/NCT03270280
org study id: UniversityHSL
nct id: NCT03270280
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Periodontitis is an infectious inflammatory disease affecting the periodontal tissue
      (Gingivae, alveolar bone, periodontal ligament and cementum). Chronic Periodontitis is
      considered to be the most prevalent disease after dental caries which is linked to increased
      levels of C- reactive protein, interleukins and matrix metallo-proteinases. Interleukin- 1β
      and Matrix metalloproteinase-8 have been shown to be robust markers of inflammatory cascade
      of chronic periodontitis.Various treatment modalities including scaling and root planing,
      toothpastes and chlorhexidine based mouthwashes have been are known to be associated with
      various side effects like teeth staining, altered taste sensation, mucosal burning. Hence,the
      use of natural medicaments could provide a better alternative because of their fewer side
      effects and cost effectiveness.
Periodontal disease is one of the most common diseases in humans and is responsible for most
      of the tooth loss in adults. World health Organisation report of 2005 described that the
      global problem persisted with the worldwide oral diseases such as dental caries, periodontal
      disease, tooth loss, oral mucosal lesions and oro-pharyngeal cancer. According to a local
      study the prevalence of periodontitis is found to be more in males of older age group and
      more in rural areas owing to the lack of awareness of importance of oral hygiene.

      Apart from various conventional treatment option for periodontitis a number of herbal
      medicinal intervention have been used for its treatment. Plant extracts and herbs that have
      been used previously used for periodontal therapy include Salvadora persica, Arnica Montana
      and Hamamelis virginiana which have been shown to exhibit antibacterial activity against
      periodonto-pathic bacteria. Phytomedicines (Medicines derived from herbal plants) like indian
      gum arabic, aloe vera, nim, carvacrol, garlic, wild coffee and propolis resin have been used
      in dentistry as anti-inflammatory, antibiotics, analgesic and hypnotic agents. Propolis
      resin, guava and triphala have been also been used for the treatment of periodontitis
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Healthy Individuals with Chronic Periodontitis Only
primary purpose: Health Services Research
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Triple Blind
measure: Levels of IL 1-Beta and MMP-8
time frame: 2 weeks
description: These inflammatory marker will be measured in patients saliva again after 2 weeks. There will be reduction in their levels.
arm group label: Normal Saline
arm group type: Placebo Comparator
description: The group contains healthy individuals with chronic periodontitis who will receive Normal Saline as placebo
arm group label: Nigella Sativa
arm group type: Experimental
description: The group contains healthy individuals with chronic periodontitis who will receive Nigella sativa Oil as intervention
intervention type: Drug
intervention name: Nigella Sativa Oil
description: The individuals will apply 55 drops of Nigella sativa Oil on gingivae twice daily for two weeks
arm group label: Nigella Sativa
other name: Black seed Oil
intervention type: Drug
intervention name: Normal saline
description: The individuals will apply 55 drops of Normal saline on gingivae twice daily for two weeks
arm group label: Normal Saline
other name: Saline
criteria: 
gender: All
minimum age: 19 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ghazala Hassan, MPhil
role: Principal Investigator
affiliation: Research Scholar
last name: Ghazala Hassan, MPhil
phone: +92 320 4635693
email: mashal_18@hotmail.com
last name: Sarah Ghafoor, PhD
phone: +92 324 4787457
email: sarahghafoor@uhs.edu.pk
facility: 
country: Pakistan
citation: Zadik Y, Bechor R, Galor S, Levin L. Periodontal disease might be associated even with impaired fasting glucose. Br Dent J. 2010 May 22;208(10):E20. doi: 10.1038/sj.bdj.2010.291. Epub 2010 Mar 26.
PMID: 20339371
citation: Gupta N, Gupta ND, Gupta A, Khan S, Bansal N. Role of salivary matrix metalloproteinase-8 (MMP-8) in chronic periodontitis diagnosis. Front Med. 2015 Mar;9(1):72-6. doi: 10.1007/s11684-014-0347-x. Epub 2014 Aug 6.
PMID: 25098434
responsible party type: Principal Investigator
investigator affiliation: University of Health Sciences Lahore
investigator full name: Dr. Ghazala Hassan
investigator title: Research Scholar
mesh term: Periodontitis
mesh term: Chronic Periodontitis
sharing ipd: No
ipd description: Data sharing will be considered after the completion of studies