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Clinical Trials/NCT03241277
NCT03241277UnknownNot Applicable

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

University of Sao Paulo General Hospital1 site in 1 country45 target enrollmentStarted: October 5, 2017Last updated:
Conditions
Interventions

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

Experimental

Patients with social phobia with no psychiatric treatment Intervention- non surgical periodontal treatment

Intervention: Non surgical periodontal treatment (Procedure)

Social phobia under Psych T

Experimental

Patients with social phobia under psychiatric treatment (Psych T) Intervention- non surgical periodontal treatment

Intervention: Non surgical periodontal treatment (Procedure)

Controls

Active Comparator

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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