Evaluation of Nonsurgical Periodontal Treatment in Patients With Social Phobia: a Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Probing depth
Study Overview
Brief Summary
Objective: To investigate the impact of nonsurgical periodontal treatment in patients with social anxiety disorder (SAD) and controls without phobia.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Social phobia
Patients with social phobia with no psychiatric treatment Intervention- non surgical periodontal treatment
Intervention: Non surgical periodontal treatment (Procedure)
Social phobia under Psych T
Patients with social phobia under psychiatric treatment (Psych T) Intervention- non surgical periodontal treatment
Intervention: Non surgical periodontal treatment (Procedure)
Controls
Patients without social phobia Intervention- non surgical periodontal treatment
Intervention: Non surgical periodontal treatment (Procedure)
Outcomes
Primary Outcomes
Probing depth
Time Frame: Change from baseline at 6 months
the distance from the clinical gingival margin to probe tip
Secondary Outcomes
- Clinical attachment level(Change from baseline at 6 months)
