<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/NCT02214095</url>
  </required_header>
  <id_info>
    <org_study_id>randomized clinical trial</org_study_id>
    <nct_id>NCT02214095</nct_id>
  </id_info>
  <brief_title>Glucosamine Periodontal Adjunctive Therapy</brief_title>
  <official_title>Glucosamine Sulphate as an Adjunctive Therapy to Closed Mechanical Debridement Reduced Gingival Cervicular Fluid IL-1β in Patients With Chronic Periodontitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is the first evidence based work evaluated the systemic use of glucosamine as an&#xD;
      adjunctive therapy to closed mechanical debridement in chronic periodontitis. The use of&#xD;
      glucosamine sulphate was correlated with clinical outcomes and IL1-β level in the GCF of&#xD;
      patients with moderate to advanced chronic periodontitis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Targeting the inflammatory response may be a rational approach to the medical treatment of&#xD;
      chronic periodontitis. Glucosamine sulphate (GS) was proven to have anti-inflammatory actions&#xD;
      with minimal side effect profile. Objectives; The main objectives of this study were to&#xD;
      evaluate clinically the efficacy of GS; as a novel adjunctive host modulating agent in&#xD;
      periodontal therapy and to investigate its effect on gingival crevicular fluid (GCF) level of&#xD;
      IL-1β. Methods; Forty patients with moderate to severe chronic periodontitis (CP) were&#xD;
      included in this study. They were randomly divided into two groups. Group I (G1) patients&#xD;
      (n=20) received 500 mg GS capsules three times daily for 3 months following full mouth&#xD;
      scaling and root planing (SRP), while group II (G2) patients (n=20) received a placebo for&#xD;
      the same period following full mouth SRP. Clinical periodontal parameters and GCF IL-1β&#xD;
      levels were analyzed at baseline and 3 months following therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    had been finished&#xD;
  </why_stopped>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>gingival crevicular fluid IL-1β level</measure>
    <time_frame>0-3 months</time_frame>
    <description>baseline and after three months of Glucosamine Sulphate administration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>probing depth</measure>
    <time_frame>0-3 months</time_frame>
    <description>the distance from the gingival margin to the base of the pocket was measured at baseline and 3 months after drug administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>clinical attachment level</measure>
    <time_frame>0-3 months</time_frame>
    <description>distance from cemento-enamel junction and base of the pocket was measured at baseline and 3 months after drug administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>gingival index</measure>
    <time_frame>0-3 months</time_frame>
    <description>gingival inflammation was measured by gingival index at baseline and 3 months after drug administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plaque index</measure>
    <time_frame>0-3 months</time_frame>
    <description>plaque deposits was measured by plaque index at baseline and 3 months after drug therapy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Chronic Periodontitis</condition>
  <arm_group>
    <arm_group_label>glucosamine sulphate capsules</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>500 mg Glucosamine Compound, three times daily for 3 months following initial cause related therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>lactose capsules</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>lactose capsules three times daily for 3 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>glucosamine sulphate</intervention_name>
    <description>group I (G1) patients received 500 mg glucosamine sulphate capsules (Glucosamine Compound) , three times daily for 3 months following initial cause related therapy. Group II patients were given placebo capsules( Lactose) for the same period following initial cause related therapy</description>
    <arm_group_label>glucosamine sulphate capsules</arm_group_label>
    <other_name>antiarthritis drugs</other_name>
    <other_name>antiinflammatory drugs</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>lactose capsules</intervention_name>
    <arm_group_label>lactose capsules</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. good compliance with the plaque control instructions following initial therapy&#xD;
&#xD;
          2. each subject contributed a single premolar or molar tooth with interproximal probing&#xD;
             depth ≥ 5 mm and clinical attachment loss ≥ 4 mm&#xD;
&#xD;
          3. teeth involved were all vital with score 0-1 mobility&#xD;
&#xD;
          4. availability for the follow-up and maintenance program;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. no systemic diseases which could influence the outcome of therapy as evidenced by&#xD;
             Burket's Oral Medicine health history questionnaire&#xD;
&#xD;
          2. absence of periodontal treatment for the previous year&#xD;
&#xD;
          3. absence of systemic medication or antibiotic treatment for the previous six months&#xD;
&#xD;
          4. absence of a smoking habit.&#xD;
&#xD;
          5. post menopausal, pregnant or breast feeding women were excluded from participating in&#xD;
             the study. Patients with contraindications to glucosamine sulphate therapy e.g.,&#xD;
             hypersensitivity to any of the product's components or with inadequate compliance with&#xD;
             the oral hygiene maintenance schedule were also excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>48 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmaed Y Gamal</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ainshams University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hala A Elela, professer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ainshams University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mai S Attia, Lecturer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Al-Azhar University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ainshams University</name>
      <address>
        <city>Cairo</city>
        <zip>11566</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>August 11, 2014</last_update_submitted>
  <last_update_submitted_qc>August 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Mai Shafik Attia</investigator_full_name>
    <investigator_title>lecturer of oral medicine and periodontology</investigator_title>
  </responsible_party>
  <keyword>Cytokines</keyword>
  <keyword>interleukin-1β</keyword>
  <keyword>chronic periodontitis</keyword>
  <keyword>host modulation</keyword>
  <keyword>glucosamine sulphate.</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Inflammatory Agents</mesh_term>
  </intervention_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/NCT02214095
org study id: randomized clinical trial
nct id: NCT02214095
lead sponsor: 
has dmc: Yes
This study is the first evidence based work evaluated the systemic use of glucosamine as an
      adjunctive therapy to closed mechanical debridement in chronic periodontitis. The use of
      glucosamine sulphate was correlated with clinical outcomes and IL1-β level in the GCF of
      patients with moderate to advanced chronic periodontitis
Targeting the inflammatory response may be a rational approach to the medical treatment of
      chronic periodontitis. Glucosamine sulphate (GS) was proven to have anti-inflammatory actions
      with minimal side effect profile. Objectives; The main objectives of this study were to
      evaluate clinically the efficacy of GS; as a novel adjunctive host modulating agent in
      periodontal therapy and to investigate its effect on gingival crevicular fluid (GCF) level of
      IL-1β. Methods; Forty patients with moderate to severe chronic periodontitis (CP) were
      included in this study. They were randomly divided into two groups. Group I (G1) patients
      (n=20) received 500 mg GS capsules three times daily for 3 months following full mouth
      scaling and root planing (SRP), while group II (G2) patients (n=20) received a placebo for
      the same period following full mouth SRP. Clinical periodontal parameters and GCF IL-1β
      levels were analyzed at baseline and 3 months following therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: gingival crevicular fluid IL-1β level
time frame: 0-3 months
description: baseline and after three months of Glucosamine Sulphate administration
measure: probing depth
time frame: 0-3 months
description: the distance from the gingival margin to the base of the pocket was measured at baseline and 3 months after drug administration
measure: clinical attachment level
time frame: 0-3 months
description: distance from cemento-enamel junction and base of the pocket was measured at baseline and 3 months after drug administration
measure: gingival index
time frame: 0-3 months
description: gingival inflammation was measured by gingival index at baseline and 3 months after drug administration.
measure: plaque index
time frame: 0-3 months
description: plaque deposits was measured by plaque index at baseline and 3 months after drug therapy
arm group label: glucosamine sulphate capsules
arm group type: Active Comparator
description: 500 mg Glucosamine Compound, three times daily for 3 months following initial cause related therapy.
arm group label: lactose capsules
arm group type: Placebo Comparator
description: lactose capsules three times daily for 3 months
intervention type: Drug
intervention name: glucosamine sulphate
description: group I (G1) patients received 500 mg glucosamine sulphate capsules (Glucosamine Compound) , three times daily for 3 months following initial cause related therapy. Group II patients were given placebo capsules( Lactose) for the same period following initial cause related therapy
arm group label: glucosamine sulphate capsules
other name: antiarthritis drugs
other name: antiinflammatory drugs
intervention type: Drug
intervention name: lactose capsules
arm group label: lactose capsules
criteria: 
gender: All
minimum age: 35 Years
maximum age: 48 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ahmaed Y Gamal
role: Principal Investigator
affiliation: Ainshams University
last name: Hala A Elela, professer
role: Principal Investigator
affiliation: Ainshams University
last name: Mai S Attia, Lecturer
role: Principal Investigator
affiliation: Al-Azhar University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Mai Shafik Attia
investigator title: lecturer of oral medicine and periodontology
mesh term: Periodontitis
mesh term: Chronic Periodontitis
mesh term: Anti-Inflammatory Agents