GriefOHGRIEFNCT03286647
Oral Hygiene Self-efficacy in Patients With Grief
A study testing Oral hygiene instruction in people with Grief, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
to investigate the effect of oral hygiene self-efficacy in patients with grief (G) and complicated grief (CG) Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Grief
- What is being tested?
- Oral hygiene instruction
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Oct 2017to 5 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of grief or complicated grief
- Informed consent signature
Who cannot join
- Patients with severe major depressive disorder at risk for suicide;
- Substance abuse or dependence,
- Psychotic disorders
- Systemic alteration that precludes periodontal clinical examination
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department and Institute of Psychiatry - FMUSP
São Paulo, São Paulo, 05403-903
Francisco Lotufo-Neto, PhD, (05511) 2661-6988, franciscolotufo@gmail.com
Ana Cristina Solis, PhD, (05511) 2661-6988, anacristinasolis@hotmail.com
About this study
Official title: Evaluation of Oral Hygiene Self-efficacy in Patients With Grief: a Short-term Randomized Controlled Clinical Trial
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.
- Conditions
- Grief
- Being tested
- Oral hygiene instruction
- Keywords
- grief, periodontal disease
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral hygiene instructionProcedure or surgery
the participants will receive instructions to perform a satisfatory oral hygiene
| Study group | Role | What they receive |
|---|---|---|
| NORMALGRIEF | Experimental | Oral hygiene instruction Receives: Procedure: Oral hygiene instruction |
| COMPLICATEDGRIEF | Experimental | Oral hygiene instruction Receives: Procedure: Oral hygiene instruction |
| CONTROLS | Active comparator | Oral hygiene instruction Receives: Procedure: Oral hygiene instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of dental plaque
frequency of dental plaque at 6 sites per tooth
Measured: Change from baseline, 1 and 3 months after oral hygiene instruction
Secondary outcomes (3)
probing depth
distance of gingival margin to probe tip
Measured: Change from baseline and 3 months after oral hygiene instruction
clinical attachment level
distance of cemento-enamel junction to probe tip
Measured: Change from baseline and 3 months after oral hygiene instruction
Bleeding on probing
frequency of bleeding on probing at 6 sites per tooth
Measured: Change from baseline, 1 and 3 months after oral hygiene instruction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start5 Oct 2017 (estimated)
- Primary completion5 Oct 2017 (estimated)
- Study completion5 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GriefStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Lotufo Neto, University of Sao Paulo General Hospital
- Investigators
- Francisco Lotufo-Neto, PhD, Study chair, ProfessorAna Cristina Solis, PhD, Principal investigator, Fellowship
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286647
- Sponsor's protocol ID
- 47071315.0.0000.0068
- Acronym
- OHGRIEF
- Status last verified
- Sep 2017
- First submitted
- 31 Aug 2017
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oral Hygiene Self-efficacy in Patients With Grief: a Short-term Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03286647
- Acronym / sponsor ID
- OHGRIEF / 47071315.0.0000.0068
- Conditions
- Grief
- Keywords
- grief, periodontal disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 5 Oct 2017 (estimated)
- Primary completion
- 5 Oct 2017 (estimated)
- Study completion
- 5 Oct 2018 (estimated)
- First posted
- 18 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
to investigate the effect of oral hygiene self-efficacy in patients with grief (G) and complicated grief (CG)
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NORMALGRIEF | Experimental | Procedure: Oral hygiene instructionOral hygiene instruction |
| COMPLICATEDGRIEF | Experimental | Procedure: Oral hygiene instructionOral hygiene instruction |
| CONTROLS | Active comparator | Procedure: Oral hygiene instructionOral hygiene instruction |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of grief or complicated grief
- Informed consent signature
Key exclusion criteria (4 listed)
- Patients with severe major depressive disorder at risk for suicide;
- Substance abuse or dependence,
- Psychotic disorders
- Systemic alteration that precludes periodontal clinical examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral hygiene instructionthe participants will receive instructions to perform a satisfatory oral hygiene | Procedure or surgery | COMPLICATEDGRIEF, CONTROLS, NORMALGRIEF |
Primary outcome
Frequency of dental plaque
Time frame: Change from baseline, 1 and 3 months after oral hygiene instruction
frequency of dental plaque at 6 sites per tooth
3 secondary outcomes
probing depth
Time frame: Change from baseline and 3 months after oral hygiene instruction
clinical attachment level
Time frame: Change from baseline and 3 months after oral hygiene instruction
Bleeding on probing
Time frame: Change from baseline, 1 and 3 months after oral hygiene instruction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco Lotufo-Neto, PhD study chair
Professor
Ana Cristina Solis, PhD principal investigator
Fellowship
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral hygiene instruction in people with Grief, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francisco Lotufo-Neto, PhD ((05511) 2661-6988, franciscolotufo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of dental plaque (time frame: Change from baseline, 1 and 3 months after oral hygiene instruction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2017.