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Trial record 2 of 26 for:    Recruiting, Not yet recruiting, Available Studies | "Bereavement"

Oral Hygiene Self-efficacy in Patients With Grief (OHGRIEF)

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ClinicalTrials.gov Identifier: NCT03286647
Recruitment Status : Not yet recruiting
First Posted : September 18, 2017
Last Update Posted : September 18, 2017
Sponsor:
Information provided by (Responsible Party):
Francisco Lotufo Neto, University of Sao Paulo General Hospital

Brief Summary:
to investigate the effect of oral hygiene self-efficacy in patients with grief (G) and complicated grief (CG)

Condition or disease Intervention/treatment Phase
Grief Procedure: Oral hygiene instruction Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Oral Hygiene Self-efficacy in Patients With Grief: a Short-term Randomized Controlled Clinical Trial
Estimated Study Start Date : October 5, 2017
Estimated Primary Completion Date : October 5, 2017
Estimated Study Completion Date : October 5, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NORMALGRIEF
Oral hygiene instruction
Procedure: Oral hygiene instruction
the participants will receive instructions to perform a satisfatory oral hygiene

Experimental: COMPLICATEDGRIEF
Oral hygiene instruction
Procedure: Oral hygiene instruction
the participants will receive instructions to perform a satisfatory oral hygiene

Active Comparator: CONTROLS
Oral hygiene instruction
Procedure: Oral hygiene instruction
the participants will receive instructions to perform a satisfatory oral hygiene




Primary Outcome Measures :
  1. Frequency of dental plaque [ Time Frame: Change from baseline, 1 and 3 months after oral hygiene instruction ]
    frequency of dental plaque at 6 sites per tooth


Secondary Outcome Measures :
  1. probing depth [ Time Frame: Change from baseline and 3 months after oral hygiene instruction ]
    distance of gingival margin to probe tip

  2. clinical attachment level [ Time Frame: Change from baseline and 3 months after oral hygiene instruction ]
    distance of cemento-enamel junction to probe tip

  3. Bleeding on probing [ Time Frame: Change from baseline, 1 and 3 months after oral hygiene instruction ]
    frequency of bleeding on probing at 6 sites per tooth



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of grief or complicated grief
  • Informed consent signature

Exclusion Criteria:

  • Patients with severe major depressive disorder at risk for suicide;
  • Substance abuse or dependence,
  • Psychotic disorders
  • Systemic alteration that precludes periodontal clinical examination

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03286647


Contacts
Contact: Francisco Lotufo-Neto, PhD (05511) 2661-6988 franciscolotufo@gmail.com

Locations
Brazil
Department and Institute of Psychiatry - FMUSP Not yet recruiting
São Paulo, Sao Paulo, Brazil, 05403-903
Contact: Francisco Lotufo-Neto, PhD    (05511) 2661-6988    franciscolotufo@gmail.com   
Contact: Ana Cristina Solis, PhD    (05511) 2661-6988    anacristinasolis@hotmail.com   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Study Chair: Francisco Lotufo-Neto, PhD Professor
Principal Investigator: Ana Cristina Solis, PhD Fellowship

Responsible Party: Francisco Lotufo Neto, Principal investigator, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03286647     History of Changes
Other Study ID Numbers: 47071315.0.0000.0068
First Posted: September 18, 2017    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Francisco Lotufo Neto, University of Sao Paulo General Hospital:
grief, periodontal disease