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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03241277
Other study ID # 33267314.9.0000.0068
Secondary ID 821.780
Status Not yet recruiting
Phase N/A
First received July 27, 2017
Last updated August 4, 2017
Start date October 5, 2017
Est. completion date October 5, 2019

Study information

Verified date July 2017
Source University of Sao Paulo General Hospital
Contact Francisco Lotufo-Neto, PhD
Phone +55-11-2661-6988
Email franciscolotufo@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


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Study Design


Intervention

Procedure:
Non surgical periodontal treatment
Scaling and root planning that will be performed with manual curettes or ultrasonic instruments

Locations

Country Name City State
Brazil Department and Institute of Psychiatry - FMUSP São Paulo Sao Paulo

Sponsors (2)

Lead Sponsor Collaborator
University of Sao Paulo General Hospital Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (24)

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Outcome

Type Measure Description Time frame Safety issue
Primary Probing depth the distance from the clinical gingival margin to probe tip Change from baseline at 6 months
Secondary Clinical attachment level The distance from cementoenamel junction to probe tip Change from baseline at 6 months
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