Nonsurgical Periodontal Treatment in Patients With Social Phobia

Periodontal Diseases Clinical Trial

— NSPTSP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03241277
• Other study ID #: 33267314.9.0000.0068
• Secondary ID: 821.780
• Status: Not yet recruiting
• Phase: N/A
• First received: July 27, 2017
• Last updated: August 4, 2017
• Start date: October 5, 2017
• Est. completion date: October 5, 2019

Study information

• Verified date: July 2017
• Source: University of Sao Paulo General Hospital
• Contact: Francisco Lotufo-Neto, PhD
• Phone: +55-11-2661-6988
• Email: franciscolotufo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: October 5, 2019
• Est. primary completion date: May 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Diseases
• Phobic Disorders
• Social Phobia

Intervention

Procedure:
• Non surgical periodontal treatment
Scaling and root planning that will be performed with manual curettes or ultrasonic instruments

Locations

Country	Name	City	State
Brazil	Department and Institute of Psychiatry - FMUSP	São Paulo	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (24)

Albandar JM, Brunelle JA, Kingman A. Destructive periodontal disease in adults 30 years of age and older in the United States, 1988-1994. J Periodontol. 1999 Jan;70(1):13-29. Erratum in: J Periodontol 1999 Mar;70(3):351. — View Citation

Andrade LH, Wang YP, Andreoni S, Silveira CM, Alexandrino-Silva C, Siu ER, Nishimura R, Anthony JC, Gattaz WF, Kessler RC, Viana MC. Mental disorders in megacities: findings from the São Paulo megacity mental health survey, Brazil. PLoS One. 2012;7(2):e31 — View Citation

Armfield JM, Slade GD, Spencer AJ. Dental fear and adult oral health in Australia. Community Dent Oral Epidemiol. 2009 Jun;37(3):220-30. doi: 10.1111/j.1600-0528.2009.00468.x. — View Citation

Bakri I, Douglas CW, Rawlinson A. The effects of stress on periodontal treatment: a longitudinal investigation using clinical and biological markers. J Clin Periodontol. 2013 Oct;40(10):955-61. doi: 10.1111/jcpe.12142. Epub 2013 Aug 18. — View Citation

Chung DT, Bogle G, Bernardini M, Stephens D, Riggs ML, Egelberg JH. Pain experienced by patients during periodontal maintenance. J Periodontol. 2003 Sep;74(9):1293-301. — View Citation

Claffey N, Polyzois I, Ziaka P. An overview of nonsurgical and surgical therapy. Periodontol 2000. 2004;36:35-44. Review. — View Citation

de Oliveira Solis AC, Araújo ÁC, Corchs F, Bernik M, Duran ÉP, 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. — View Citation

Eke PI, Dye BA, Wei L, Thornton-Evans GO, Genco RJ; CDC Periodontal Disease Surveillance workgroup: James Beck (University of North Carolina, Chapel Hill, USA), Gordon Douglass (Past President, American Academy of Periodontology), Roy Page (University of — View Citation

Eke PI, Page RC, Wei L, Thornton-Evans G, Genco RJ. Update of the case definitions for population-based surveillance of periodontitis. J Periodontol. 2012 Dec;83(12):1449-54. doi: 10.1902/jop.2012.110664. Epub 2012 Mar 16. — View Citation

Erovic Ademovski S, Mårtensson C, Persson GR, Renvert S. The effect of periodontal therapy on intra-oral halitosis: a case series. J Clin Periodontol. 2016 May;43(5):445-452. doi: 10.1111/jcpe.12525. Epub 2016 Apr 18. — View Citation

Fardal O, Hansen BF. Interviewing self-reported highly anxious patients during periodontal treatment. J Periodontol. 2007 Jun;78(6):1037-42. — View Citation

Heitz-Mayfield LJ, Lang NP. Surgical and nonsurgical periodontal therapy. Learned and unlearned concepts. Periodontol 2000. 2013 Jun;62(1):218-31. doi: 10.1111/prd.12008. Review. — View Citation

Khambaty T, Stewart JC. Associations of depressive and anxiety disorders with periodontal disease prevalence in young adults: analysis of 1999-2004 National Health and Nutrition Examination Survey (NHANES) data. Ann Behav Med. 2013 Jun;45(3):393-7. doi: 1 — View Citation

Liebowitz MR. Social phobia. Mod Probl Pharmacopsychiatry. 1987;22:141-73. — View Citation

Lima MS, Soares BG, Paoliello G, Machado Vieira R, Martins CM, Mota Neto JI, Ferrão Y, Schirmer DA, Volpe FM. The Portuguese version of the Clinical Global Impression-Schizophrenia Scale: validation study. Rev Bras Psiquiatr. 2007 Sep;29(3):246-9. — View Citation

Papapanou PN. The prevalence of periodontitis in the US: forget what you were told. J Dent Res. 2012 Oct;91(10):907-8. Epub 2012 Aug 30. — View Citation

Santuchi CC, Cortelli SC, Cortelli JR, Cota LO, Alencar CO, Costa FO. Pre- and post-treatment experiences of fear, anxiety, and pain among chronic periodontitis patients treated by scaling and root planing per quadrant versus one-stage full-mouth disinfec — View Citation

Sheehan TJ. Creating a psychosocial measurement model from stressful life events. Soc Sci Med. 1996 Jul;43(2):265-71. — View Citation

Suhas S, Sudarshan S, Pai KM. "Air bag" organoleptic behavioral experiment for managing fear of oral malodor. J Behav Ther Exp Psychiatry. 2004 Mar;35(1):13-5. — View Citation

Susin C, Dalla Vecchia CF, Oppermann RV, Haugejorden O, Albandar JM. Periodontal attachment loss in an urban population of Brazilian adults: effect of demographic, behavioral, and environmental risk indicators. J Periodontol. 2004 Jul;75(7):1033-41. — View Citation

Susin C, Haas AN, Oppermann RV, Haugejorden O, Albandar JM. Gingival recession: epidemiology and risk indicators in a representative urban Brazilian population. J Periodontol. 2004 Oct;75(10):1377-86. — View Citation

Susin C, Valle P, Oppermann RV, Haugejorden O, Albandar JM. Occurrence and risk indicators of increased probing depth in an adult Brazilian population. J Clin Periodontol. 2005 Feb;32(2):123-9. — View Citation

Vettore M, Quintanilha RS, Monteiro da Silva AM, Lamarca GA, Leão AT. The influence of stress and anxiety on the response of non-surgical periodontal treatment. J Clin Periodontol. 2005 Dec;32(12):1226-35. — View Citation

Winkel EG, Roldán S, Van Winkelhoff AJ, Herrera D, Sanz M. Clinical effects of a new mouthrinse containing chlorhexidine, cetylpyridinium chloride and zinc-lactate on oral halitosis. A dual-center, double-blind placebo-controlled study. J Clin Periodontol — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing depth	the distance from the clinical gingival margin to probe tip	Change from baseline at 6 months
Secondary	Clinical attachment level	The distance from cementoenamel junction to probe tip	Change from baseline at 6 months