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Trial record 6 of 55 for:    Recruiting, Not yet recruiting, Available Studies | "Phobic Disorders"

Nonsurgical Periodontal Treatment in Patients With Social Phobia (NSPTSP)

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ClinicalTrials.gov Identifier: NCT03241277
Recruitment Status : Not yet recruiting
First Posted : August 7, 2017
Last Update Posted : August 7, 2017
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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 Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Non 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
Estimated Study Start Date : October 5, 2017
Estimated Primary Completion Date : May 5, 2019
Estimated Study Completion Date : October 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Phobias

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 Name: 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 Name: 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 Name: scaling and root planning




Primary Outcome Measures :
  1. Probing depth [ Time Frame: Change from baseline at 6 months ]
    the distance from the clinical gingival margin to probe tip


Secondary Outcome Measures :
  1. Clinical attachment level [ Time Frame: Change from baseline at 6 months ]
    The distance from cementoenamel junction to probe tip



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03241277


Contacts
Contact: Francisco Lotufo-Neto, PhD +55-11-2661-6988 franciscolotufo@gmail.com
Contact: Ana Cristina Solis, PhD +55-11-2661-6988 anacristinasolis@hotmail.com

Locations
Brazil
Department and Institute of Psychiatry - FMUSP Not yet recruiting
São Paulo, Sao Paulo, Brazil, 05403-903
Contact: Francisco Lotufo-Neto, PhD    (011) 2661-6988    franciscolotufo@gmail.com   
Contact: Ana Cristina Solis, PhD    (011) 2661-6988    anacristinasolis@hotmail.com   
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

Publications of Results:

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03241277     History of Changes
Other Study ID Numbers: 33267314.9.0000.0068
821.780 ( Registry Identifier: USaoPauloGH )
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Sao Paulo General Hospital:
social phobia
anxiety disorders
DSM-IV TR
periodontal disease
non surgical periodontal treatment

Additional relevant MeSH terms:
Periodontal Diseases
Gingival Diseases
Phobic Disorders
Phobia, Social
Mouth Diseases
Stomatognathic Diseases
Anxiety Disorders
Mental Disorders