Nonsurgical Periodontal Treatment in Patients With Social Phobia

NCT ID: NCT03241277

Last Updated: 2017-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-05

Study Completion Date

2019-10-05

Brief Summary

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

Detailed Description

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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.

Conditions

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Social Phobia Periodontal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Non surgical periodontal treatment
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Social phobia

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

Group Type EXPERIMENTAL

Non surgical periodontal treatment

Intervention Type PROCEDURE

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

Social phobia under Psych T

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

Group Type EXPERIMENTAL

Non surgical periodontal treatment

Intervention Type PROCEDURE

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

Controls

Patients without social phobia Intervention- non surgical periodontal treatment

Group Type ACTIVE_COMPARATOR

Non surgical periodontal treatment

Intervention Type PROCEDURE

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

Interventions

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Non surgical periodontal treatment

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

Intervention Type PROCEDURE

Other Intervention Names

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scaling and root planning

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francisco Lotufo-Neto, PhD

Role: STUDY_CHAIR

Faculdade de Medicina FMUSP, Universidade de Sao Paulo, SP, Sao Paulo, SP, BR

Ana Cristina Solis, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculdade de Medicina FMUSP, Universidade de Sao Paulo, SP, Sao Paulo, SP, BR

Locations

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Department and Institute of Psychiatry - FMUSP

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Francisco Lotufo-Neto, PhD

Role: CONTACT

+55-11-2661-6988

Ana Cristina Solis, PhD

Role: CONTACT

+55-11-2661-6988

Facility Contacts

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Francisco Lotufo-Neto, PhD

Role: primary

(011) 2661-6988

Ana Cristina Solis, PhD

Role: backup

(011) 2661-6988

References

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de Oliveira Solis AC, Araujo AC, Corchs F, Bernik M, Duran EP, Silva C, Lotufo-Neto F. Impact of post-traumatic stress disorder on oral health. J Affect Disord. 2017 Sep;219:126-132. doi: 10.1016/j.jad.2017.05.033. Epub 2017 May 20.

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Other Identifiers

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821.780

Identifier Type: REGISTRY

Identifier Source: secondary_id

33267314.9.0000.0068

Identifier Type: -

Identifier Source: org_study_id

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