CClinicalTrials.gg
Status unknownNCT03286647OHGRIEFUpdated Sep 18, 2017

Oral Hygiene Self-efficacy in Patients With Grief

An interventional study of Oral hygiene instruction in Grief, sponsored by University of Sao Paulo General Hospital. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-18.

Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Grief

Keywords

  • grief, periodontal disease
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Diagnosis of grief or complicated grief
  • Informed consent signature

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    NORMALGRIEF

    Oral hygiene instruction

    Procedure: Oral hygiene instruction

  • Experimental
    COMPLICATEDGRIEF

    Oral hygiene instruction

    Procedure: Oral hygiene instruction

  • Active comparator
    CONTROLS

    Oral hygiene instruction

    Procedure: Oral hygiene instruction

Interventions

  • ProcedureOral hygiene instruction

    the participants will receive instructions to perform a satisfatory oral hygiene

05

What researchers measure

Primary outcomes

  1. Frequency of dental plaque

    frequency of dental plaque at 6 sites per tooth

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

Secondary outcomes

  1. probing depth

    distance of gingival margin to probe tip

    Time frame: Change from baseline and 3 months after oral hygiene instruction

  2. clinical attachment level

    distance of cemento-enamel junction to probe tip

    Time frame: Change from baseline and 3 months after oral hygiene instruction

  3. Bleeding on probing

    frequency of bleeding on probing at 6 sites per tooth

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

06

Study locations

1 site
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03286647
Lead sponsor
University of Sao Paulo General Hospital
Responsible party
Francisco Lotufo Neto (Principal investigator, University of Sao Paulo General Hospital) — Principal investigator
First posted
Sep 18, 2017
Start date
Oct 5, 2017 (estimated)
Primary completion
Oct 5, 2017 (estimated)
Completion
Oct 5, 2018 (estimated)
Last update
Sep 18, 2017

Study contacts

Francisco Lotufo-Neto, PhD
Contact
franciscolotufo@gmail.com
(05511) 2661-6988
Francisco Lotufo-Neto, PhD
study chair · Professor
Ana Cristina Solis, PhD
principal investigator · Fellowship

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion