Oral Hygiene Self-efficacy in Patients With Grief

Not Applicable

• Conditions: Grief
• Interventions: Procedure: Oral hygiene instruction

• Registration Number: NCT03286647
• Lead Sponsor: 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)

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 Timeline

• Study First Submitted: 2017-08-31
• Status Verified: 2017-09
• Study First Submitted QC: 2017-09-14
• Last Update Submitted: 2017-09-14
• Study First Posted: 2017-09-18
• Last Update Posted: 2017-09-18
• Study Start: 2017-10-05
• Primary Completion: 2017-10-05
• Study Completion: 2018-10-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CONTROLS	Oral hygiene instruction	Oral hygiene instruction
COMPLICATEDGRIEF	Oral hygiene instruction	Oral hygiene instruction
NORMALGRIEF	Oral hygiene instruction	Oral hygiene instruction

Primary Outcome Measures

Name	Time	Method
Frequency of dental plaque	Change from baseline, 1 and 3 months after oral hygiene instruction	frequency of dental plaque at 6 sites per tooth

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department and Institute of Psychiatry - FMUSP; 🇧🇷 São Paulo, Sao Paulo, Brazil