Nonsurgical Periodontal Treatment in Patients With Social Phobia

Study Overview
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Brief Summary
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Objective: To investigate the impact of nonsurgical periodontal treatment in patients with social anxiety disorder (SAD) and controls without phobia.

Detailed Description
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Study design: randomized controlled trial. Setting: Institute of Psychiatry from FMUSP (Ipq-FMUSP). Subjects: patients seeking for Social Phobia treatment at IPq-FMUSP ( before and under treatment). Controls: Hospital staff at the HC-FMUSP or volunteers from a list of other studies conducted at the Ipq-FMUSP. Methods: Dental evaluation: probing depth, clinical attachment level and bleeding on probing will be recorded at 6 sites per tooth, as well as the plaque and/or calculus indexes. The number of decayed, missing and filled teeth (DMFT index) will be also assessed. The visual analogue scale (VAS) will be applied for the assessment of pain after probing after the probing recording. Patients will receive a clinical evaluation for halitosis using a Halimeter® to verify the concentration of the volatile sulfur compounds (before and after periodontal treatment). Main psychiatric assessment: Structured Clinical Interview (SCID) for DSM-IV-TR adapted for DSM-5, the Liebowitz Social Anxiety (LSAs). Duration and frequency: after the initial clinical assessment (dental and psychiatric) patients will be randomized into three groups. Two groups (experimental- social phobia with no psychiatric treatment and control) will receive periodontal treatment after the initial psychiatric evaluation. One group will receive periodontal treatment after the improvement of psychiatric condition (3 months after the initial assessment). The non-surgical periodontal treatment will be performed preferably within 24 h. Patients will be reevaluated 3 and 6 months after the end of nonsurgical periodontal treatment.

Official Title
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Evaluation of Nonsurgical Periodontal Treatment in Patients With Social Phobia: a Randomized Controlled Clinical Trial

Conditions
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Social Phobia, Periodontal Diseases

Intervention / Treatment
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* Procedure: Non surgical periodontal treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Social Phobia according to the DSM-IV TR adapted for the DSM-5 Patients with cut-off score of 4 (moderately ill) in the Global Clinical Impression (GCI) rating scale Informed consent signature Exclusion Criteria: Patients with severe major depressive disorder at risk for suicide; substance abuse or dependence, psychotic disorders or psychotherapy treatment Patients in psychotherapy treatment Systemic alteration that precludes periodontal clinical examination

Ages Eligible for Study
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Minimum Age: 35 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
Interventional Model Description: Non surgical periodontal treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Social phobia<br>Patients with social phobia with no psychiatric treatment Intervention- non surgical periodontal treatment | Procedure: Non surgical periodontal treatment<br>* Scaling and root planning that will be performed with manual curettes or ultrasonic instruments<br>* Other names: scaling and root planning;|
| Experimental: Social phobia under Psych T<br>Patients with social phobia under psychiatric treatment (Psych T) Intervention- non surgical periodontal treatment | Procedure: Non surgical periodontal treatment<br>* Scaling and root planning that will be performed with manual curettes or ultrasonic instruments<br>* Other names: scaling and root planning;|
| Active Comparator: Controls<br>Patients without social phobia Intervention- non surgical periodontal treatment | Procedure: Non surgical periodontal treatment<br>* Scaling and root planning that will be performed with manual curettes or ultrasonic instruments<br>* Other names: scaling and root planning;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing depth | the distance from the clinical gingival margin to probe tip | Change from baseline at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical attachment level | The distance from cementoenamel junction to probe tip | Change from baseline at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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social phobia, anxiety disorders, DSM-IV TR, periodontal disease, non surgical periodontal treatment