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

U

University of Sao Paulo General Hospital

Status

Unknown

Conditions

Grief

Treatments

Procedure: Oral hygiene instruction

Study type

Interventional

Funder types

Other

Identifiers

NCT03286647
47071315.0.0000.0068

Details and patient eligibility

About

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

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 3 patient groups

NORMALGRIEF
Experimental group
Description:
Oral hygiene instruction
Treatment:
Procedure: Oral hygiene instruction
COMPLICATEDGRIEF
Experimental group
Description:
Oral hygiene instruction
Treatment:
Procedure: Oral hygiene instruction
CONTROLS
Active Comparator group
Description:
Oral hygiene instruction
Treatment:
Procedure: Oral hygiene instruction

Trial contacts and locations

1

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Central trial contact

Francisco Lotufo-Neto, PhD

Data sourced from clinicaltrials.gov

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