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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03286647
Other study ID # 47071315.0.0000.0068
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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