<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/NCT03286647</url>
  </required_header>
  <id_info>
    <org_study_id>47071315.0.0000.0068</org_study_id>
    <nct_id>NCT03286647</nct_id>
  </id_info>
  <brief_title>Oral Hygiene Self-efficacy in Patients With Grief</brief_title>
  <acronym>OHGRIEF</acronym>
  <official_title>Evaluation of Oral Hygiene Self-efficacy in Patients With Grief: a Short-term Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo General Hospital</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>
      to investigate the effect of oral hygiene self-efficacy in patients with grief (G) and&#xD;
      complicated grief (CG)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim: to investigate the effect of oral hygiene self-efficacy in patients with grief (G) and&#xD;
      complicated grief (CG). Study design: randomized controlled trial. Setting: Institute of&#xD;
      Psychiatry-FMUSP (Ipq-FMUSP). Subjects: cases: patients seeking for treatment or under&#xD;
      treatment for CG (Group 1), and patients with normal grief (Group 2). Controls: Hospital&#xD;
      staff at the HC-FMUSP or volunteers from a list of other studies conducted at the Ipq-FMUSP&#xD;
      (Group 3). Method. Psychiatric evaluation: Structured Clinical Interview (SCID), Texas&#xD;
      Revised Inventory of Grief (TRIG) and clinical interview. Intervention: instruction of oral&#xD;
      hygiene. Dental evaluation: probing depth, clinical attachment level, bleeding on probing,&#xD;
      and frequency of plaque at six sites per tooth. Procedures: all participants will complete&#xD;
      the psychiatry and dental evaluation at baseline. The bleeding on probing and frequency of&#xD;
      plaque will be recorded at baseline, once a week (1 month follow-up) and at 3 months. The&#xD;
      probing depth and clinical attachment level will be recorded at baseline and at 3 months.&#xD;
      After 3 months, the patients will be referred for dental treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 5, 2017</start_date>
  <completion_date type="Anticipated">October 5, 2018</completion_date>
  <primary_completion_date type="Anticipated">October 5, 2017</primary_completion_date>
  <phase>N/A</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of dental plaque</measure>
    <time_frame>Change from baseline, 1 and 3 months after oral hygiene instruction</time_frame>
    <description>frequency of dental plaque at 6 sites per tooth</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>probing depth</measure>
    <time_frame>Change from baseline and 3 months after oral hygiene instruction</time_frame>
    <description>distance of gingival margin to probe tip</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>clinical attachment level</measure>
    <time_frame>Change from baseline and 3 months after oral hygiene instruction</time_frame>
    <description>distance of cemento-enamel junction to probe tip</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding on probing</measure>
    <time_frame>Change from baseline, 1 and 3 months after oral hygiene instruction</time_frame>
    <description>frequency of bleeding on probing at 6 sites per tooth</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Grief</condition>
  <arm_group>
    <arm_group_label>NORMALGRIEF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral hygiene instruction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COMPLICATEDGRIEF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral hygiene instruction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CONTROLS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oral hygiene instruction</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Oral hygiene instruction</intervention_name>
    <description>the participants will receive instructions to perform a satisfatory oral hygiene</description>
    <arm_group_label>COMPLICATEDGRIEF</arm_group_label>
    <arm_group_label>CONTROLS</arm_group_label>
    <arm_group_label>NORMALGRIEF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of grief or complicated grief&#xD;
&#xD;
          -  Informed consent signature&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with severe major depressive disorder at risk for suicide;&#xD;
&#xD;
          -  Substance abuse or dependence,&#xD;
&#xD;
          -  Psychotic disorders&#xD;
&#xD;
          -  Systemic alteration that precludes periodontal clinical examination&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Francisco Lotufo-Neto, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ana Cristina Solis, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fellowship</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Francisco Lotufo-Neto, PhD</last_name>
    <phone>(05511) 2661-6988</phone>
    <email>franciscolotufo@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department and Institute of Psychiatry - FMUSP</name>
      <address>
        <city>São Paulo</city>
        <state>Sao Paulo</state>
        <zip>05403-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <contact>
      <last_name>Francisco Lotufo-Neto, PhD</last_name>
      <phone>(05511) 2661-6988</phone>
      <email>franciscolotufo@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Ana Cristina Solis, PhD</last_name>
      <phone>(05511) 2661-6988</phone>
      <email>anacristinasolis@hotmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>September 14, 2017</last_update_submitted>
  <last_update_submitted_qc>September 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo General Hospital</investigator_affiliation>
    <investigator_full_name>Francisco Lotufo Neto</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>grief, periodontal disease</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT03286647
org study id: 47071315.0.0000.0068
nct id: NCT03286647
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
to investigate the effect of oral hygiene self-efficacy in patients with grief (G) and
      complicated grief (CG)
Aim: to investigate the effect of oral hygiene self-efficacy in patients with grief (G) and
      complicated grief (CG). Study design: randomized controlled trial. Setting: Institute of
      Psychiatry-FMUSP (Ipq-FMUSP). Subjects: cases: patients seeking for treatment or under
      treatment for CG (Group 1), and patients with normal grief (Group 2). Controls: Hospital
      staff at the HC-FMUSP or volunteers from a list of other studies conducted at the Ipq-FMUSP
      (Group 3). Method. Psychiatric evaluation: Structured Clinical Interview (SCID), Texas
      Revised Inventory of Grief (TRIG) and clinical interview. Intervention: instruction of oral
      hygiene. Dental evaluation: probing depth, clinical attachment level, bleeding on probing,
      and frequency of plaque at six sites per tooth. Procedures: all participants will complete
      the psychiatry and dental evaluation at baseline. The bleeding on probing and frequency of
      plaque will be recorded at baseline, once a week (1 month follow-up) and at 3 months. The
      probing depth and clinical attachment level will be recorded at baseline and at 3 months.
      After 3 months, the patients will be referred for dental treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Frequency of dental plaque
time frame: Change from baseline, 1 and 3 months after oral hygiene instruction
description: frequency of dental plaque at 6 sites per tooth
measure: probing depth
time frame: Change from baseline and 3 months after oral hygiene instruction
description: distance of gingival margin to probe tip
measure: clinical attachment level
time frame: Change from baseline and 3 months after oral hygiene instruction
description: distance of cemento-enamel junction to probe tip
measure: Bleeding on probing
time frame: Change from baseline, 1 and 3 months after oral hygiene instruction
description: frequency of bleeding on probing at 6 sites per tooth
arm group label: NORMALGRIEF
arm group type: Experimental
description: Oral hygiene instruction
arm group label: COMPLICATEDGRIEF
arm group type: Experimental
description: Oral hygiene instruction
arm group label: CONTROLS
arm group type: Active Comparator
description: Oral hygiene instruction
intervention type: Procedure
intervention name: Oral hygiene instruction
description: the participants will receive instructions to perform a satisfatory oral hygiene
arm group label: COMPLICATEDGRIEF
arm group label: CONTROLS
arm group label: NORMALGRIEF
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Francisco Lotufo-Neto, PhD
role: Study Chair
affiliation: Professor
last name: Ana Cristina Solis, PhD
role: Principal Investigator
affiliation: Fellowship
last name: Francisco Lotufo-Neto, PhD
phone: (05511) 2661-6988
email: franciscolotufo@gmail.com
facility: 
contact: 
contact backup: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo General Hospital
investigator full name: Francisco Lotufo Neto
investigator title: Principal investigator
sharing ipd: No