Oral Hygiene Self-efficacy in Patients With Grief

Grief Clinical Trial

— OHGRIEF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03286647
• Other study ID #: 47071315.0.0000.0068
• Status: Not yet recruiting
• Phase: N/A
• First received: August 31, 2017
• Last updated: September 14, 2017
• Start date: October 5, 2017
• Est. completion date: October 5, 2018

Study information

• Verified date: September 2017
• Source: University of Sao Paulo General Hospital
• Contact: Francisco Lotufo-Neto, PhD
• Phone: (05511) 2661-6988
• Email: franciscolotufo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: October 5, 2018
• Est. primary completion date: October 5, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Grief

Intervention

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

Locations

Country	Name	City	State
Brazil	Department and Institute of Psychiatry - FMUSP	São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

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