Clinical trial NCT03241277: Nonsurgical Periodontal Treatment in Patients With Social Phobia
Official title: Evaluation of Nonsurgical Periodontal Treatment in Patients With Social Phobia: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Social Phobia
Periodontal Diseases
Keywords: social phobia
anxiety disorders
DSM-IV TR
periodontal disease
non surgical periodontal treatment
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2017-08-07
Enrollment: 45
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non surgical periodontal treatment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Probing depth
timeFrame: Change from baseline at 6 months
Secondary outcomes:
measure: Clinical attachment level
timeFrame: Change from baseline at 6 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Department and Institute of Psychiatry - FMUSP
state: Sao Paulo
Study officials:
affiliation: Faculdade de Medicina FMUSP, Universidade de Sao Paulo, SP, Sao Paulo, SP, BR
name: Francisco Lotufo-Neto, PhD
role: STUDY_CHAIR
affiliation: Faculdade de Medicina FMUSP, Universidade de Sao Paulo, SP, Sao Paulo, SP, BR
name: Ana Cristina Solis, PhD
role: PRINCIPAL_INVESTIGATOR
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