<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/NCT03791957</url>
  </required_header>
  <id_info>
    <org_study_id>riya2pigmentation</org_study_id>
    <nct_id>NCT03791957</nct_id>
  </id_info>
  <brief_title>The Association of Blood Haemoglobin and Colour of Gums</brief_title>
  <official_title>The Association of the Levels of Blood Haemoglobin to the Distribution and Severity of Gingival Melanin Pigmentation at 3 Different Periodontal Health Status</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KLE Society's Institute of Dental Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KLE Society's Institute of Dental Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      AIM:&#xD;
&#xD;
      To evaluate the association of the levels of blood haemoglobin to the distribution and&#xD;
      severity of gingival melanin pigmentation at 3 different periodontal health status&#xD;
&#xD;
      SAMPLE SIZE ESTIMATION&#xD;
&#xD;
        -  Done using GPower v.3.1.9.2&#xD;
&#xD;
        -  Total sample size = 60 (20 each in 3 groups)&#xD;
&#xD;
        -  Effect size = 40%&#xD;
&#xD;
        -  Power = 80%&#xD;
&#xD;
        -  α-error = 5%&#xD;
&#xD;
      SAMPLING:&#xD;
&#xD;
        -  Simple random sampling&#xD;
&#xD;
        -  Subjects to be recruited from out patient pool of KLE Society's Institute of Dental&#xD;
           Sciences, Bangalore&#xD;
&#xD;
        -  Subjects to be categorised into 3 groups (20 subjects each)&#xD;
&#xD;
             1. Group A - Healthy periodontium&#xD;
&#xD;
             2. Group B - Gingivitis&#xD;
&#xD;
             3. Group C - Periodontitis&#xD;
&#xD;
      PARAMETERS ASSESSED&#xD;
&#xD;
        -  Blood Haemoglobin Concentration (in %gm/dL)&#xD;
&#xD;
        -  Hedin Melanin Index Score 0: No pigmentation Score 1: one or two solitary unit(s) of&#xD;
           pigmentation in papillary gingiva without formation of a continuous ribbon between&#xD;
           solitary units Score 2: More than three units of pigmentation in papillary gingiva&#xD;
           without the formation of a continuous ribbons of pigmentation Score 3: One or more short&#xD;
           continuous ribbons of pigmentation Score 4: One continuous ribbon including the entire&#xD;
           area between canines&#xD;
&#xD;
      STATISTICAL ANALYSIS&#xD;
&#xD;
        -  SPSS for Windows Version 22.0 to be used&#xD;
&#xD;
        -  Descriptive statistics: It includes expression of study parameters in terms of Mean &amp; SD&#xD;
           for continuous variables, whereas in terms of frequency and proportions for categorical&#xD;
           variables.&#xD;
&#xD;
        -  Inferential Statistics:&#xD;
&#xD;
      Chi Square Test will be used to compare the pigmentation index between 03 groups. And&#xD;
      similarly, gender wise comparison of hemoglobin concentration will be done using the same&#xD;
      test.&#xD;
&#xD;
      One-way ANOVA test followed by Tukey's HSD post hoc Analysis will be used to compare the mean&#xD;
      hemoglobin levels based on the pigmentation index scores in each group.&#xD;
&#xD;
      The level of significance [P-Value] was set at P&lt;0.05&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 20, 2019</start_date>
  <completion_date type="Anticipated">January 2020</completion_date>
  <primary_completion_date type="Anticipated">January 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Week</target_duration>
  <primary_outcome>
    <measure>Blood Haemoglobin to Melanin pigmentation</measure>
    <time_frame>Baseline</time_frame>
    <description>To assess the association of the levels of blood haemoglobin to the distribution and severity of gingival melanin pigmentation at 3 different periodontal health status by Hedin Melanin Index both by intragroup comparison within each of the 3 groups and intergroup comparison between the three groups</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Gingival Pigmentation</condition>
  <condition>Gingivitis</condition>
  <condition>Periodontitis</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Group A - Healthy Periodontium</arm_group_label>
    <description>Absence of clinical signs of inflammation like bleeding on probing, erythema, edema, attachment loss, bone loss, patient symptoms, (bone levels at 1-3mm apical to CEJ) n=20</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B - Gingivitis</arm_group_label>
    <description>Presence of cardinal signs of inflammation along with, bleeding and discomfort on gentle probing, loss of knife-edged margin and blunting of papilla, n=20</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C - Periodontitis</arm_group_label>
    <description>Presence of cardinal signs of inflammation along with, bleeding and discomfort on gentle probing, loss of knife-edged margin and blunting of papilla,periodontal pocketing, clinical attachment loss, radiographically assessed bone loss n=20</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood Haemoglobin</intervention_name>
    <description>Routine haemotological investigation of blood haemoglobin levels in gm/dL will be recorded from withdrawn venous blood</description>
    <arm_group_label>Group A - Healthy Periodontium</arm_group_label>
    <arm_group_label>Group B - Gingivitis</arm_group_label>
    <arm_group_label>Group C - Periodontitis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects to be recruited from out patient pool of KLE Society's Institute of Dental&#xD;
        Sciences, Bangalore, India&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Systemically healthy individuals&#xD;
&#xD;
          -  Absence of pathological gingival pigmentation&#xD;
&#xD;
               1. Group A - Healthy Periodontium: Absence of clinical signs of inflammation like&#xD;
                  bleeding on probing, erythema, edema, attachment loss, bone loss, patient&#xD;
                  symptoms, (bone levels at 1-3mm apical to CEJ)&#xD;
&#xD;
               2. Group B - Gingivitis: Presence of cardinal signs of inflammation along with,&#xD;
                  bleeding and discomfort on gentle probing, loss of knife-edged margin and&#xD;
                  blunting of papilla,&#xD;
&#xD;
               3. Group C - Periodontitis: Presence of cardinal signs of inflammation along with,&#xD;
                  bleeding and discomfort on gentle probing, loss of knife-edged margin and&#xD;
                  blunting of papilla,periodontal pocketing, clinical attachment loss,&#xD;
                  radiographically assessed bone loss&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Tobacco associated pigmentation - smoker's melanosis, chewing/ pouching tobacco&#xD;
&#xD;
          -  Pigmentation from exogenous pigments - amalgam tattoo, cultural tattooing, beverages,&#xD;
             food colours, betelnut/khat chewing, heavy metals ( mercury, silver, arsenic, bismuth,&#xD;
             graphite, lead), topical medications, other foreign bodies&#xD;
&#xD;
          -  Pigmentation from endogenous pigments - jaundice, ecchymosis/ petechiae,&#xD;
             haemochromatosis, hemosiderin&#xD;
&#xD;
          -  Long term consumption of pigmentation causing drugs - ACTH, antimalarial drugs,&#xD;
             busulfan, doxorubicin, minocycline, oral contraceptives, phenothiazies&#xD;
&#xD;
          -  Syndromes and systemic diseases associated with pigmentation - Addison's disease.&#xD;
             Albright's syndrome, basila melanosis, β-thalassemia, healed / healing mucocutaneous&#xD;
             lesions, hereditary hemorrhagic Telangiectasia, HIV-associated melanosis,&#xD;
             Neurofibromatosis, Peutz Jeghers syndrome, hamartoma, pyogenic granuloma, epulis&#xD;
&#xD;
          -  Benign or malignant lesions involving gingival - angiosarcoma, hemangioma, Kaposi's&#xD;
             sarcoma, malignant melanoma, melanocytic nevus, pigmented vaculoe&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Riya A Daniel, BDS, PG student</last_name>
    <phone>9444140560</phone>
    <phone_ext>+91</phone_ext>
    <email>riyaad.rd@gmail.com</email>
  </overall_contact>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>December 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>December 13, 2019</last_update_submitted>
  <last_update_submitted_qc>December 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KLE Society's Institute of Dental Sciences</investigator_affiliation>
    <investigator_full_name>Dr. Riya Achamma Daniel</investigator_full_name>
    <investigator_title>Post graduate student, Principal investigator, Department of Periodontics, KLE Society's Institute of Dental Sciences, Bangalore</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gingivitis</mesh_term>
    <mesh_term>Periodontitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chrysarobin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>April 21, 2020</submitted>
    <returned>May 1, 2020</returned>
  </pending_results>
  <!-- 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/NCT03791957
org study id: riya2pigmentation
nct id: NCT03791957
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
AIM:

      To evaluate the association of the levels of blood haemoglobin to the distribution and
      severity of gingival melanin pigmentation at 3 different periodontal health status

      SAMPLE SIZE ESTIMATION

        -  Done using GPower v.3.1.9.2

        -  Total sample size = 60 (20 each in 3 groups)

        -  Effect size = 40%

        -  Power = 80%

        -  α-error = 5%

      SAMPLING:

        -  Simple random sampling

        -  Subjects to be recruited from out patient pool of KLE Society's Institute of Dental
           Sciences, Bangalore

        -  Subjects to be categorised into 3 groups (20 subjects each)

             1. Group A - Healthy periodontium

             2. Group B - Gingivitis

             3. Group C - Periodontitis

      PARAMETERS ASSESSED

        -  Blood Haemoglobin Concentration (in %gm/dL)

        -  Hedin Melanin Index Score 0: No pigmentation Score 1: one or two solitary unit(s) of
           pigmentation in papillary gingiva without formation of a continuous ribbon between
           solitary units Score 2: More than three units of pigmentation in papillary gingiva
           without the formation of a continuous ribbons of pigmentation Score 3: One or more short
           continuous ribbons of pigmentation Score 4: One continuous ribbon including the entire
           area between canines

      STATISTICAL ANALYSIS

        -  SPSS for Windows Version 22.0 to be used

        -  Descriptive statistics: It includes expression of study parameters in terms of Mean & SD
           for continuous variables, whereas in terms of frequency and proportions for categorical
           variables.

        -  Inferential Statistics:

      Chi Square Test will be used to compare the pigmentation index between 03 groups. And
      similarly, gender wise comparison of hemoglobin concentration will be done using the same
      test.

      One-way ANOVA test followed by Tukey's HSD post hoc Analysis will be used to compare the mean
      hemoglobin levels based on the pigmentation index scores in each group.

      The level of significance [P-Value] was set at P<0.05
observational model: Other
time perspective: Cross-Sectional
measure: Blood Haemoglobin to Melanin pigmentation
time frame: Baseline
description: To assess the association of the levels of blood haemoglobin to the distribution and severity of gingival melanin pigmentation at 3 different periodontal health status by Hedin Melanin Index both by intragroup comparison within each of the 3 groups and intergroup comparison between the three groups
arm group label: Group A - Healthy Periodontium
description: Absence of clinical signs of inflammation like bleeding on probing, erythema, edema, attachment loss, bone loss, patient symptoms, (bone levels at 1-3mm apical to CEJ) n=20
arm group label: Group B - Gingivitis
description: Presence of cardinal signs of inflammation along with, bleeding and discomfort on gentle probing, loss of knife-edged margin and blunting of papilla, n=20
arm group label: Group C - Periodontitis
description: Presence of cardinal signs of inflammation along with, bleeding and discomfort on gentle probing, loss of knife-edged margin and blunting of papilla,periodontal pocketing, clinical attachment loss, radiographically assessed bone loss n=20
intervention type: Other
intervention name: Blood Haemoglobin
description: Routine haemotological investigation of blood haemoglobin levels in gm/dL will be recorded from withdrawn venous blood
arm group label: Group A - Healthy Periodontium
arm group label: Group B - Gingivitis
arm group label: Group C - Periodontitis
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Riya A Daniel, BDS, PG student
phone: 9444140560
phone ext: +91
email: riyaad.rd@gmail.com
responsible party type: Principal Investigator
investigator affiliation: KLE Society's Institute of Dental Sciences
investigator full name: Dr. Riya Achamma Daniel
investigator title: Post graduate student, Principal investigator, Department of Periodontics, KLE Society's Institute of Dental Sciences, Bangalore
mesh term: Gingivitis
mesh term: Periodontitis
mesh term: Chrysarobin
sharing ipd: No
submitted: April 21, 2020
returned: May 1, 2020