Nonsurgical Periodontal Treatment in Patients With Social Phobia (NSPTSP)

August 4, 2017 updated by: University of Sao Paulo General Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 05403-903
        • Department and Institute of Psychiatry - FMUSP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

31 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing depth
Time Frame: Change from baseline at 6 months
the distance from the clinical gingival margin to probe tip
Change from baseline at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical attachment level
Time Frame: Change from baseline at 6 months
The distance from cementoenamel junction to probe tip
Change from baseline at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 5, 2017

Primary Completion (Anticipated)

May 5, 2019

Study Completion (Anticipated)

October 5, 2019

Study Registration Dates

First Submitted

July 27, 2017

First Submitted That Met QC Criteria

August 4, 2017

First Posted (Actual)

August 7, 2017

Study Record Updates

Last Update Posted (Actual)

August 7, 2017

Last Update Submitted That Met QC Criteria

August 4, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 33267314.9.0000.0068
  • 821.780 (Registry Identifier: USaoPauloGH)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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