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Nonsurgical Periodontal Treatment in Patients With Social Phobia

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03241277
Acronym
NSPTSP
Enrollment
45
Registered
2017-08-07
Start date
2017-10-05
Completion date
2019-10-05
Last updated
2017-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Diseases, Social Phobia

Keywords

social phobia, anxiety disorders, DSM-IV TR, periodontal disease, non surgical periodontal treatment

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.

Interventions

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Non surgical periodontal treatment

Eligibility

Sex/Gender
ALL
Age
35 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Probing depthChange from baseline at 6 monthsthe distance from the clinical gingival margin to probe tip

Secondary

MeasureTime frameDescription
Clinical attachment levelChange from baseline at 6 monthsThe distance from cementoenamel junction to probe tip

Countries

Brazil

Contacts

Primary ContactFrancisco Lotufo-Neto, PhD
franciscolotufo@gmail.com+55-11-2661-6988
Backup ContactAna Cristina Solis, PhD
anacristinasolis@hotmail.com+55-11-2661-6988

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026