<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/NCT02263352</url>
  </required_header>
  <id_info>
    <org_study_id>10/98/12</org_study_id>
    <nct_id>NCT02263352</nct_id>
  </id_info>
  <brief_title>A Clinical Trial to Study the Effect of Lycopene in Patients With Gum Disease and type2 Diabetes Mellitus</brief_title>
  <acronym>&quot;SLSRPD&quot;</acronym>
  <official_title>Systemic Lycopene as an Adjunct to Scaling and Rootplaning in Chronic Periodontitis Patients With Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Panineeya Mahavidyalaya Institute of Dental Sciences &amp; Research Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Health and Nutrition</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Panineeya Mahavidyalaya Institute of Dental Sciences &amp; Research Centre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was performed to assess the efficacy of systemic lycopene (8 mgms Daily for two&#xD;
      months) as an adjunct to scaling and root planing in chronic periodontitis patients with type&#xD;
      2 diabetes mellitus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomized double blinded clinical trial which was performed to assess the&#xD;
      efficacy of systemic lycopene (8 mgms Daily for two months) as an adjunct to scaling and root&#xD;
      planing in chronic periodontitis patients with type 2 diabetes mellitus. The primary outcome&#xD;
      measures were Serum MDA, CRP and Hb1AC. The secondary outcomes were modified gingival&#xD;
      index(GI), Probing pocket depth(PPD), and Clinical attachment level(CAL). All the outcomes&#xD;
      were measured at baseline, 2 months and 6 months.&#xD;
&#xD;
      The results were that the Lycopene with scaling and root planing group gave:&#xD;
&#xD;
      Statistically significant results in reducing Mean serum MDA levels at 2 months and 6 months&#xD;
      respectively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>Phase 4</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>Change in Serum MDA</measure>
    <time_frame>6 Months Post treatment.</time_frame>
    <description>This unique outcome measure was assessed from baseline to 6 months post treatment by spectrophotometric estimation of serum Thiobarbituric acid substances (TBARS). The TBARS Assay measures malondialdehyde (MDA), a reactive compound formed from lipid peroxides that are generated under conditions of oxidative stress. Oxidative modification of lipids occurs with aging and various diseases, and increased oxidative stress is associated with diabetes and its complications. MDA forms an adduct with thiobarbituric acid (TBA). Results are calculated from a standard curve constructed with authentic MDA.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Modified Gingival Index</measure>
    <time_frame>6 Months post treatment.</time_frame>
    <description>The change in Modified gingival index from baseline to 6 months post treatment was assessed full mouth at 6 sites /tooth with Hufreidy Periodontal probe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Probing pocket depth (PPD)</measure>
    <time_frame>6 Months post treatment.</time_frame>
    <description>The change in Probing pocket depth from baseline to 6 months post treatment was assessed full mouth at 6 sites /tooth with Hufreidy Periodontal probe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Clinical attachment level (CAL)</measure>
    <time_frame>6 Months post treatment.</time_frame>
    <description>The change in CAL from baseline to 6 months post treatment was assessed full mouth at 6 sites /tooth with Hufreidy Periodontal probe.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Positive Regulation of Oxidative Stress Process</condition>
  <arm_group>
    <arm_group_label>Lycored soft gels , Scaling and Rootplaning.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Systemic Lycored soft gels,(Jagsonpal Pharma) was given orally 8mgms/day for 2 months and Scaling and rootplaning (otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or deep cleaning, is the process of removing or eliminating the etiologic agents - dental plaque, its products, and calculus) which was performed at baseline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Scaling and Rootplaning only.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Scaling and rootplaning(otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or deep cleaning, is the process of removing or eliminating the etiologic agents - dental plaque, its products, and calculus) which was performed at baseline.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lycored soft gels Jagsonpal Pharma, Systemic 8mgms/day</intervention_name>
    <description>Lycopene 8mgms taken orally ,one per day for two months.</description>
    <arm_group_label>Lycored soft gels , Scaling and Rootplaning.</arm_group_label>
    <other_name>rhodopurpurin,non-provitamin A carotenoid,</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Scaling and root planing</intervention_name>
    <description>Scaling and root planing, otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or deep cleaning, is the process of removing or eliminating the etiologic agents - dental plaque, its products, and calculus</description>
    <arm_group_label>Lycored soft gels , Scaling and Rootplaning.</arm_group_label>
    <arm_group_label>Scaling and Rootplaning only.</arm_group_label>
    <other_name>Nonsurgical periodontal therapy, Conventional periodontal therapy.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Type 2 diabetes&#xD;
&#xD;
          -  Patients on oral hypoglycemic drugs with no modification in therapy from the past 12&#xD;
             months&#xD;
&#xD;
          -  Chronic periodontitis as per AAP (American Academy of Periodontology) guidelines&#xD;
&#xD;
          -  Minimum of 15 natural teeth&#xD;
&#xD;
          -  At least four teeth with one or more sites with probing depth (PD) greater than or&#xD;
             equal to 5 mm, clinical attachment level (CAL) greater than or equal to 4mm and&#xD;
             bleeding on probing (BOP).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        History of antibiotic therapy within the previous 6 months&#xD;
&#xD;
          -  History of anti-inflammatory drugs within the previous 3 months&#xD;
&#xD;
          -  Pregnancy and lactation&#xD;
&#xD;
          -  Use of contraceptives or any other form of hormone&#xD;
&#xD;
          -  Usage of tobacco and tobacco related products&#xD;
&#xD;
          -  Periodontal treatment within 12 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr.Manasa Ambati, MDS(Perio)</last_name>
    <role>Principal Investigator</role>
    <affiliation>Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre,Road no:5,Kamala nagar,Dilsukhnagar,Hyderabad,India.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre</name>
      <address>
        <city>Hyderabad</city>
        <zip>500060</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <reference>
    <citation>Neyestani TR, Shariatzadeh N, Gharavi A, Kalayi A, Khalaji N. Physiological dose of lycopene suppressed oxidative stress and enhanced serum levels of immunoglobulin M in patients with Type 2 diabetes mellitus: a possible role in the prevention of long-term complications. J Endocrinol Invest. 2007 Nov;30(10):833-8. doi: 10.1007/BF03349224.</citation>
    <PMID>18075285</PMID>
  </reference>
  <reference>
    <citation>Chandra RV, Prabhuji ML, Roopa DA, Ravirajan S, Kishore HC. Efficacy of lycopene in the treatment of gingivitis: a randomised, placebo-controlled clinical trial. Oral Health Prev Dent. 2007;5(4):327-36.</citation>
    <PMID>18173095</PMID>
  </reference>
  <results_reference>
    <citation>Cohen DW, Friedman LA, Shapiro J, Kyle GC, Franklin S. Diabetes mellitus and periodontal disease: two-year longitudinal observations. I. J Periodontol. 1970 Dec;41(12):709-12. doi: 10.1902/jop.1970.41.12.709. No abstract available.</citation>
    <PMID>5275715</PMID>
  </results_reference>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>October 8, 2014</last_update_submitted>
  <last_update_submitted_qc>October 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 13, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Panineeya Mahavidyalaya Institute of Dental Sciences &amp; Research Centre</investigator_affiliation>
    <investigator_full_name>Manasa Ambati</investigator_full_name>
    <investigator_title>Dr.Manasa Ambati</investigator_title>
  </responsible_party>
  <keyword>Diabetes, Periodontitis, Oxidative stress, Antioxidant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carotenoids</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/NCT02263352
org study id: 10/98/12
nct id: NCT02263352
lead sponsor: 
collaborator: 
has dmc: Yes
This study was performed to assess the efficacy of systemic lycopene (8 mgms Daily for two
      months) as an adjunct to scaling and root planing in chronic periodontitis patients with type
      2 diabetes mellitus.
This study is a randomized double blinded clinical trial which was performed to assess the
      efficacy of systemic lycopene (8 mgms Daily for two months) as an adjunct to scaling and root
      planing in chronic periodontitis patients with type 2 diabetes mellitus. The primary outcome
      measures were Serum MDA, CRP and Hb1AC. The secondary outcomes were modified gingival
      index(GI), Probing pocket depth(PPD), and Clinical attachment level(CAL). All the outcomes
      were measured at baseline, 2 months and 6 months.

      The results were that the Lycopene with scaling and root planing group gave:

      Statistically significant results in reducing Mean serum MDA levels at 2 months and 6 months
      respectively.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in Serum MDA
time frame: 6 Months Post treatment.
description: This unique outcome measure was assessed from baseline to 6 months post treatment by spectrophotometric estimation of serum Thiobarbituric acid substances (TBARS). The TBARS Assay measures malondialdehyde (MDA), a reactive compound formed from lipid peroxides that are generated under conditions of oxidative stress. Oxidative modification of lipids occurs with aging and various diseases, and increased oxidative stress is associated with diabetes and its complications. MDA forms an adduct with thiobarbituric acid (TBA). Results are calculated from a standard curve constructed with authentic MDA.
measure: Change in Modified Gingival Index
time frame: 6 Months post treatment.
description: The change in Modified gingival index from baseline to 6 months post treatment was assessed full mouth at 6 sites /tooth with Hufreidy Periodontal probe.
measure: Change in Probing pocket depth (PPD)
time frame: 6 Months post treatment.
description: The change in Probing pocket depth from baseline to 6 months post treatment was assessed full mouth at 6 sites /tooth with Hufreidy Periodontal probe.
measure: Change in Clinical attachment level (CAL)
time frame: 6 Months post treatment.
description: The change in CAL from baseline to 6 months post treatment was assessed full mouth at 6 sites /tooth with Hufreidy Periodontal probe.
arm group label: Lycored soft gels , Scaling and Rootplaning.
arm group type: Experimental
description: Systemic Lycored soft gels,(Jagsonpal Pharma) was given orally 8mgms/day for 2 months and Scaling and rootplaning (otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or deep cleaning, is the process of removing or eliminating the etiologic agents - dental plaque, its products, and calculus) which was performed at baseline
arm group label: Scaling and Rootplaning only.
arm group type: Experimental
description: Scaling and rootplaning(otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or deep cleaning, is the process of removing or eliminating the etiologic agents - dental plaque, its products, and calculus) which was performed at baseline.
intervention type: Drug
intervention name: Lycored soft gels Jagsonpal Pharma, Systemic 8mgms/day
description: Lycopene 8mgms taken orally ,one per day for two months.
arm group label: Lycored soft gels , Scaling and Rootplaning.
other name: rhodopurpurin,non-provitamin A carotenoid,
intervention type: Device
intervention name: Scaling and root planing
description: Scaling and root planing, otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or deep cleaning, is the process of removing or eliminating the etiologic agents - dental plaque, its products, and calculus
arm group label: Lycored soft gels , Scaling and Rootplaning.
arm group label: Scaling and Rootplaning only.
other name: Nonsurgical periodontal therapy, Conventional periodontal therapy.
criteria: 
gender: All
minimum age: 35 Years
maximum age: 50 Years
healthy volunteers: No
last name: Dr.Manasa Ambati, MDS(Perio)
role: Principal Investigator
affiliation: Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre,Road no:5,Kamala nagar,Dilsukhnagar,Hyderabad,India.
facility: 
country: India
citation: Neyestani TR, Shariatzadeh N, Gharavi A, Kalayi A, Khalaji N. Physiological dose of lycopene suppressed oxidative stress and enhanced serum levels of immunoglobulin M in patients with Type 2 diabetes mellitus: a possible role in the prevention of long-term complications. J Endocrinol Invest. 2007 Nov;30(10):833-8. doi: 10.1007/BF03349224.
PMID: 18075285
citation: Chandra RV, Prabhuji ML, Roopa DA, Ravirajan S, Kishore HC. Efficacy of lycopene in the treatment of gingivitis: a randomised, placebo-controlled clinical trial. Oral Health Prev Dent. 2007;5(4):327-36.
PMID: 18173095
citation: Cohen DW, Friedman LA, Shapiro J, Kyle GC, Franklin S. Diabetes mellitus and periodontal disease: two-year longitudinal observations. I. J Periodontol. 1970 Dec;41(12):709-12. doi: 10.1902/jop.1970.41.12.709. No abstract available.
PMID: 5275715
responsible party type: Principal Investigator
investigator affiliation: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
investigator full name: Manasa Ambati
investigator title: Dr.Manasa Ambati
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Carotenoids