NCT03286647

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 18, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

October 5, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2018

Completed
Last Updated

September 18, 2017

Status Verified

September 1, 2017

Enrollment Period

Same day

First QC Date

August 31, 2017

Last Update Submit

September 14, 2017

Conditions

Grief

Keywords

grief, periodontal disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • probing depth

    Change from baseline and 3 months after oral hygiene instruction

  • clinical attachment level

    Change from baseline and 3 months after oral hygiene instruction

  • Bleeding on probing

    Change from baseline, 1 and 3 months after oral hygiene instruction

Study Arms (3)

NORMALGRIEF

EXPERIMENTAL

Oral hygiene instruction

Procedure: Oral hygiene instruction

COMPLICATEDGRIEF

EXPERIMENTAL

Oral hygiene instruction

Procedure: Oral hygiene instruction

CONTROLS

ACTIVE COMPARATOR

Oral hygiene instruction

Procedure: Oral hygiene instruction

Interventions

Oral hygiene instructionPROCEDURE

the participants will receive instructions to perform a satisfatory oral hygiene

COMPLICATEDGRIEFCONTROLSNORMALGRIEF

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of grief or complicated grief
  • Informed consent signature

You may not qualify if:

  • Patients with severe major depressive disorder at risk for suicide;
  • Substance abuse or dependence,
  • Psychotic disorders
  • Systemic alteration that precludes periodontal clinical examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department and Institute of Psychiatry - FMUSP

São Paulo, São Paulo, 05403-903, Brazil

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Francisco Lotufo-Neto, PhD

    Professor

    STUDY CHAIR

  • Ana Cristina Solis, PhD

    Fellowship

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francisco Lotufo-Neto, PhD

CONTACT

(05511) 2661-6988franciscolotufo@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 31, 2017

First Posted

September 18, 2017

Study Start

October 5, 2017

Primary Completion

October 5, 2017

Study Completion

October 5, 2018

Last Updated

September 18, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)