Nonsurgical Periodontal Treatment in Patients With Social Phobia
NSPTSP
Evaluation of Nonsurgical Periodontal Treatment in Patients With Social Phobia: a Randomized Controlled Clinical Trial
2 other identifiers
interventional
45
1 country
1
Brief Summary
Objective: To investigate the impact of nonsurgical periodontal treatment in patients with social anxiety disorder (SAD) and controls without phobia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2017
CompletedFirst Posted
Study publicly available on registry
August 7, 2017
CompletedStudy Start
First participant enrolled
October 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 5, 2019
CompletedAugust 7, 2017
July 1, 2017
1.6 years
July 27, 2017
August 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Probing depth
the distance from the clinical gingival margin to probe tip
Change from baseline at 6 months
Secondary Outcomes (1)
Clinical attachment level
Change from baseline at 6 months
Study Arms (3)
Social phobia
EXPERIMENTALPatients with social phobia with no psychiatric treatment Intervention- non surgical periodontal treatment
Social phobia under Psych T
EXPERIMENTALPatients with social phobia under psychiatric treatment (Psych T) Intervention- non surgical periodontal treatment
Controls
ACTIVE COMPARATORPatients without social phobia Intervention- non surgical periodontal treatment
Interventions
Scaling and root planning that will be performed with manual curettes or ultrasonic instruments
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department and Institute of Psychiatry - FMUSP
São Paulo, São Paulo, 05403-903, Brazil
Related 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. doi: 10.1902/jop.1999.70.1.13.
PMID: 10052767RESULTAndrade 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 Sao Paulo megacity mental health survey, Brazil. PLoS One. 2012;7(2):e31879. doi: 10.1371/journal.pone.0031879. Epub 2012 Feb 14.
PMID: 22348135RESULTArmfield 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.
PMID: 19508270RESULTBakri 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.
PMID: 23952266RESULTChung 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. doi: 10.1902/jop.2003.74.9.1293.
PMID: 14584861RESULTClaffey N, Polyzois I, Ziaka P. An overview of nonsurgical and surgical therapy. Periodontol 2000. 2004;36:35-44. doi: 10.1111/j.1600-0757.2004.00073.x. No abstract available.
PMID: 15330942RESULTEke 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 Washin. Prevalence of periodontitis in adults in the United States: 2009 and 2010. J Dent Res. 2012 Oct;91(10):914-20. doi: 10.1177/0022034512457373. Epub 2012 Aug 30.
PMID: 22935673RESULTEke 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.
PMID: 22420873RESULTErovic Ademovski S, Martensson 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.
PMID: 26847598RESULTFardal O, Hansen BF. Interviewing self-reported highly anxious patients during periodontal treatment. J Periodontol. 2007 Jun;78(6):1037-42. doi: 10.1902/jop.2007.060407.
PMID: 17539717RESULTHeitz-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.
PMID: 23574468RESULTKhambaty 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: 10.1007/s12160-013-9471-0.
PMID: 23389686RESULTPapapanou PN. The prevalence of periodontitis in the US: forget what you were told. J Dent Res. 2012 Oct;91(10):907-8. doi: 10.1177/0022034512458692. Epub 2012 Aug 30. No abstract available.
PMID: 22935674RESULTSantuchi 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 disinfection: a 6-month randomized controlled clinical trial. J Clin Periodontol. 2015 Nov;42(11):1024-31. doi: 10.1111/jcpe.12472. Epub 2015 Nov 14.
PMID: 26461465RESULTSheehan TJ. Creating a psychosocial measurement model from stressful life events. Soc Sci Med. 1996 Jul;43(2):265-71. doi: 10.1016/0277-9536(95)00377-0.
PMID: 8844930RESULTSuhas 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. doi: 10.1016/j.jbtep.2004.01.001.
PMID: 15157814RESULTSusin 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. doi: 10.1111/j.1600-051X.2005.00637.x.
PMID: 15691340RESULTSusin 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. doi: 10.1902/jop.2004.75.10.1377.
PMID: 15562916RESULTSusin 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. doi: 10.1902/jop.2004.75.7.1033.
PMID: 15341364RESULTVettore M, Quintanilha RS, Monteiro da Silva AM, Lamarca GA, Leao AT. The influence of stress and anxiety on the response of non-surgical periodontal treatment. J Clin Periodontol. 2005 Dec;32(12):1226-35. doi: 10.1111/j.1600-051X.2005.00852.x.
PMID: 16268999RESULTWinkel EG, Roldan 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. 2003 Apr;30(4):300-6. doi: 10.1034/j.1600-051x.2003.00342.x.
PMID: 12694427RESULTde 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.
PMID: 28549330RESULTLiebowitz MR. Social phobia. Mod Probl Pharmacopsychiatry. 1987;22:141-73. doi: 10.1159/000414022. No abstract available.
PMID: 2885745RESULTLima MS, Soares BG, Paoliello G, Machado Vieira R, Martins CM, Mota Neto JI, Ferrao Y, Schirmer DA, Volpe FM. The Portuguese version of the Clinical Global Impression-Schizophrenia Scale: validation study. Braz J Psychiatry. 2007 Sep;29(3):246-9. doi: 10.1590/s1516-44462007000300010.
PMID: 17891261RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2017
First Posted
August 7, 2017
Study Start
October 5, 2017
Primary Completion
May 5, 2019
Study Completion
October 5, 2019
Last Updated
August 7, 2017
Record last verified: 2017-07