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

Evaluation of Oral Hygiene Self-efficacy in Patients With Grief: a Short-term Randomized Controlled Clinical Trial

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

Study Overview

• Status: Unknown
• Conditions: Grief
• Intervention / Treatment: Procedure: Oral hygiene instruction

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
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • São Paulo, Sao Paulo, Brazil, 05403-903
      • Department and Institute of Psychiatry - FMUSP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of dental plaque	frequency of dental plaque at 6 sites per tooth	Change from baseline, 1 and 3 months after oral hygiene instruction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
probing depth	distance of gingival margin to probe tip	Change from baseline and 3 months after oral hygiene instruction
clinical attachment level	distance of cemento-enamel junction to probe tip	Change from baseline and 3 months after oral hygiene instruction
Bleeding on probing	frequency of bleeding on probing at 6 sites per tooth	Change from baseline, 1 and 3 months after oral hygiene instruction

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Study Chair: Francisco Lotufo-Neto, PhD, Professor; Principal Investigator: Ana Cristina Solis, PhD, fellowship

Study record dates

Study Major Dates

• Study Start (Anticipated): October 5, 2017
• Primary Completion (Anticipated): October 5, 2017
• Study Completion (Anticipated): October 5, 2018

Study Registration Dates

• First Submitted: August 31, 2017
• First Submitted That Met QC Criteria: September 14, 2017
• First Posted (Actual): September 18, 2017

Study Record Updates

• Last Update Posted (Actual): September 18, 2017
• Last Update Submitted That Met QC Criteria: September 14, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: grief, periodontal disease
• Other Study ID Numbers: 47071315.0.0000.0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No