NSPTSP: Nonsurgical Periodontal Treatment in Patients With Social Phobia

Sponsor

University of Sao Paulo General Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03241277

Collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Social Phobia Periodontal Diseases	Procedure: Non surgical periodontal treatment	N/A

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

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Non surgical periodontal treatmentNon surgical periodontal treatment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 5, 2017

Anticipated Primary Completion Date :

May 5, 2019

Anticipated Study Completion Date :

Oct 5, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Social phobia Patients with social phobia with no psychiatric treatment Intervention- non surgical periodontal treatment	Procedure: Non surgical periodontal treatment Scaling and root planning that will be performed with manual curettes or ultrasonic instruments Other Names: scaling and root planning
Experimental: Social phobia under Psych T Patients with social phobia under psychiatric treatment (Psych T) Intervention- non surgical periodontal treatment	Procedure: Non surgical periodontal treatment Scaling and root planning that will be performed with manual curettes or ultrasonic instruments Other Names: scaling and root planning
Active Comparator: Controls Patients without social phobia Intervention- non surgical periodontal treatment	Procedure: Non surgical periodontal treatment Scaling and root planning that will be performed with manual curettes or ultrasonic instruments Other Names: scaling and root planning

Arm

Intervention/Treatment

Experimental: Social phobia

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

Procedure: Non surgical periodontal treatment

Scaling and root planning that will be performed with manual curettes or ultrasonic instruments

Other Names:

scaling and root planning

Experimental: Social phobia under Psych T

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

Procedure: Non surgical periodontal treatment

Scaling and root planning that will be performed with manual curettes or ultrasonic instruments

Other Names:

scaling and root planning

Active Comparator: Controls

Patients without social phobia Intervention- non surgical periodontal treatment

Procedure: Non surgical periodontal treatment

Scaling and root planning that will be performed with manual curettes or ultrasonic instruments

Other Names:

scaling and root planning

Outcome Measures

Primary Outcome Measures

Probing depth [Change from baseline at 6 months]
the distance from the clinical gingival margin to probe tip

Secondary Outcome Measures

Clinical attachment level [Change from baseline at 6 months]
The distance from cementoenamel junction to probe tip

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 65 Years

Sexes Eligible for Study:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department and Institute of Psychiatry - FMUSP	São Paulo	Sao Paulo	Brazil	05403-903

Sponsors and Collaborators

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

Investigators

Study Chair: Francisco Lotufo-Neto, PhD, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, SP, Sao Paulo, SP, BR
Principal Investigator: Ana Cristina Solis, PhD, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, SP, Sao Paulo, SP, BR