Oral Hygiene Self-efficacy in Patients With Grief

Study Overview
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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.

Official Title
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Evaluation of Oral Hygiene Self-efficacy in Patients With Grief: a Short-term Randomized Controlled Clinical Trial

Conditions
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Grief

Intervention / Treatment
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* Procedure: Oral hygiene instruction


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NORMALGRIEF<br>Oral hygiene instruction | Procedure: Oral hygiene instruction<br>* the participants will receive instructions to perform a satisfatory oral hygiene<br>|
| Experimental: COMPLICATEDGRIEF<br>Oral hygiene instruction | Procedure: Oral hygiene instruction<br>* the participants will receive instructions to perform a satisfatory oral hygiene<br>|
| Active Comparator: CONTROLS<br>Oral hygiene instruction | Procedure: Oral hygiene instruction<br>* the participants will receive instructions to perform a satisfatory oral hygiene<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| probing depth | distance of gingival margin to probe tip | Change from baseline and 3 months after oral hygiene instruction | 
| clinical attachment level | distance of cemento-enamel junction to probe tip | Change from baseline and 3 months after oral hygiene instruction | 
| Bleeding on probing | frequency of bleeding on probing at 6 sites per tooth | Change from baseline, 1 and 3 months after oral hygiene instruction | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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grief, periodontal disease