Nonsurgical Periodontal Treatment in Patients With Social Phobia

Not Applicable

• Conditions: Social Phobia; Periodontal Diseases
• Interventions: Procedure: Non surgical periodontal treatment

• Registration Number: NCT03241277
• Lead Sponsor: University of Sao Paulo General Hospital

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 Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-07-27
• Study First Submitted QC: 2017-08-04
• Last Update Submitted: 2017-08-04
• Study First Posted: 2017-08-07
• Last Update Posted: 2017-08-07
• Study Start: 2017-10-05
• Primary Completion: 2019-05-05
• Study Completion: 2019-10-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Social phobia under Psych T	Non surgical periodontal treatment	Patients with social phobia under psychiatric treatment (Psych T) Intervention- non surgical periodontal treatment
Social phobia	Non surgical periodontal treatment	Patients with social phobia with no psychiatric treatment Intervention- non surgical periodontal treatment
Controls	Non surgical periodontal treatment	Patients without social phobia Intervention- non surgical periodontal treatment

Primary Outcome Measures

Name	Time	Method
Probing depth	Change from baseline at 6 months	the distance from the clinical gingival margin to probe tip

Secondary Outcome Measures

Name	Time	Method
Clinical attachment level	Change from baseline at 6 months	The distance from cementoenamel junction to probe tip

Trial Locations

Locations (1)

Department and Institute of Psychiatry - FMUSP; 🇧🇷 São Paulo, Sao Paulo, Brazil