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Oral Hygiene Self-efficacy in Patients With Grief

NCT ID: NCT03286647

Last Updated: 2017-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-05

Study Completion Date

2018-10-05

Brief Summary

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

Detailed Description

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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.

Conditions

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Grief

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NORMALGRIEF

Oral hygiene instruction

Group Type EXPERIMENTAL

Oral hygiene instruction

Intervention Type PROCEDURE

the participants will receive instructions to perform a satisfatory oral hygiene

COMPLICATEDGRIEF

Oral hygiene instruction

Group Type EXPERIMENTAL

Oral hygiene instruction

Intervention Type PROCEDURE

the participants will receive instructions to perform a satisfatory oral hygiene

CONTROLS

Oral hygiene instruction

Group Type ACTIVE_COMPARATOR

Oral hygiene instruction

Intervention Type PROCEDURE

the participants will receive instructions to perform a satisfatory oral hygiene

Interventions

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Oral hygiene instruction

the participants will receive instructions to perform a satisfatory oral hygiene

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Francisco Lotufo Neto

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francisco Lotufo-Neto, PhD

Role: STUDY_CHAIR

Professor

Ana Cristina Solis, PhD

Role: PRINCIPAL_INVESTIGATOR

Fellowship

Locations

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Department and Institute of Psychiatry - FMUSP

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Francisco Lotufo-Neto, PhD

Role: CONTACT

[email protected]
(05511) 2661-6988

Facility Contacts

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Francisco Lotufo-Neto, PhD

Role: primary

[email protected]
(05511) 2661-6988

Ana Cristina Solis, PhD

Role: backup

[email protected]
(05511) 2661-6988

Other Identifiers

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47071315.0.0000.0068

Identifier Type: -

Identifier Source: org_study_id