Nonsurgical Periodontal Treatment in Patients With Social Phobia (NSPTSP)
Primary Purpose
Social Phobia, Periodontal Diseases
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Non surgical periodontal treatment
Sponsored by
About this trial
This is an interventional treatment trial for Social Phobia focused on measuring social phobia, anxiety disorders, DSM-IV TR, periodontal disease, non surgical 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
Sites / Locations
- Department and Institute of Psychiatry - FMUSP
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Social phobia
Social phobia under Psych T
Controls
Arm Description
Patients with social phobia with no psychiatric treatment Intervention- non surgical periodontal treatment
Patients with social phobia under psychiatric treatment (Psych T) Intervention- non surgical periodontal treatment
Patients without social phobia Intervention- non surgical periodontal treatment
Outcomes
Primary Outcome Measures
Probing depth
the distance from the clinical gingival margin to probe tip
Secondary Outcome Measures
Clinical attachment level
The distance from cementoenamel junction to probe tip
Full Information
NCT ID
NCT03241277
First Posted
July 27, 2017
Last Updated
August 4, 2017
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT03241277
Brief Title
Nonsurgical Periodontal Treatment in Patients With Social Phobia
Acronym
NSPTSP
Official Title
Evaluation of Nonsurgical Periodontal Treatment in Patients With Social Phobia: a Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 5, 2017 (Anticipated)
Primary Completion Date
May 5, 2019 (Anticipated)
Study Completion Date
October 5, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Phobia, Periodontal Diseases
Keywords
social phobia, anxiety disorders, DSM-IV TR, periodontal disease, non surgical periodontal treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Non surgical periodontal treatment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Social phobia
Arm Type
Experimental
Arm Description
Patients with social phobia with no psychiatric treatment Intervention- non surgical periodontal treatment
Arm Title
Social phobia under Psych T
Arm Type
Experimental
Arm Description
Patients with social phobia under psychiatric treatment (Psych T) Intervention- non surgical periodontal treatment
Arm Title
Controls
Arm Type
Active Comparator
Arm Description
Patients without social phobia Intervention- non surgical periodontal treatment
Intervention Type
Procedure
Intervention Name(s)
Non surgical periodontal treatment
Other Intervention Name(s)
scaling and root planning
Intervention Description
Scaling and root planning that will be performed with manual curettes or ultrasonic instruments
Primary Outcome Measure Information:
Title
Probing depth
Description
the distance from the clinical gingival margin to probe tip
Time Frame
Change from baseline at 6 months
Secondary Outcome Measure Information:
Title
Clinical attachment level
Description
The distance from cementoenamel junction to probe tip
Time Frame
Change from baseline at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francisco Lotufo-Neto, PhD
Phone
+55-11-2661-6988
Email
franciscolotufo@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Cristina Solis, PhD
Phone
+55-11-2661-6988
Email
anacristinasolis@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Lotufo-Neto, PhD
Organizational Affiliation
Faculdade de Medicina FMUSP, Universidade de Sao Paulo, SP, Sao Paulo, SP, BR
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ana Cristina Solis, PhD
Organizational Affiliation
Faculdade de Medicina FMUSP, Universidade de Sao Paulo, SP, Sao Paulo, SP, BR
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department and Institute of Psychiatry - FMUSP
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05403-903
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Lotufo-Neto, PhD
Phone
(011) 2661-6988
Email
franciscolotufo@gmail.com
First Name & Middle Initial & Last Name & Degree
Ana Cristina Solis, PhD
Phone
(011) 2661-6988
Email
anacristinasolis@hotmail.com
12. IPD Sharing Statement
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Nonsurgical Periodontal Treatment in Patients With Social Phobia
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