Social PhobiaNSPTSPNCT03241277
Nonsurgical Periodontal Treatment in Patients With Social Phobia
A study testing Non surgical periodontal treatment in people with Social Phobia and Periodontal Diseases, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Objective: To investigate the impact of nonsurgical periodontal treatment in patients with social anxiety disorder (SAD) and controls without phobia. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Phobia, Periodontal Diseases
- What is being tested?
- Non surgical periodontal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Oct 2017to 5 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department and Institute of Psychiatry - FMUSP
São Paulo, São Paulo, 05403-903
Francisco Lotufo-Neto, PhD, (011) 2661-6988, franciscolotufo@gmail.com
Ana Cristina Solis, PhD, (011) 2661-6988, anacristinasolis@hotmail.com
About this study
Official title: Evaluation of Nonsurgical Periodontal Treatment in Patients With Social Phobia: a Randomized Controlled Clinical Trial
Objective: To investigate the impact of nonsurgical periodontal treatment in patients with social anxiety disorder (SAD) and controls without phobia.
Read the 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.
- Conditions
- Social Phobia, Periodontal Diseases
- Being tested
- Non surgical periodontal treatment
- Keywords
- social phobia, anxiety disorders, DSM-IV TR, periodontal disease, non surgical periodontal treatment
- Medical subject headings
- Phobia, Social, Periodontal Diseases, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non surgical periodontal treatmentProcedure or surgery
Also called scaling and root planning
Scaling and root planning that will be performed with manual curettes or ultrasonic instruments
| Study group | Role | What they receive |
|---|---|---|
| Social phobia | Experimental | Patients with social phobia with no psychiatric treatment Intervention- non surgical periodontal treatment Receives: Procedure: Non surgical periodontal treatment |
| Social phobia under Psych T | Experimental | Patients with social phobia under psychiatric treatment (Psych T) Intervention- non surgical periodontal treatment Receives: Procedure: Non surgical periodontal treatment |
| Controls | Active comparator | Patients without social phobia Intervention- non surgical periodontal treatment Receives: Procedure: Non surgical periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth
the distance from the clinical gingival margin to probe tip
Measured: Change from baseline at 6 months
Secondary outcomes (1)
Clinical attachment level
The distance from cementoenamel junction to probe tip
Measured: Change from baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start5 Oct 2017 (estimated)
- Primary completion5 May 2019 (estimated)
- Study completion5 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Social PhobiaStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non surgical periodontal treatment
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor
- Investigators
- Francisco Lotufo-Neto, PhD, Study chair, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, SP, Sao Paulo, SP, BRAna Cristina Solis, PhD, Principal investigator, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, SP, Sao Paulo, SP, BR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241277
- Sponsor's protocol ID
- 33267314.9.0000.0068
- Other IDs
- 821.780
- Acronym
- NSPTSP
- Status last verified
- Jul 2017
- First submitted
- 27 Jul 2017
- Last updated
- 7 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 10052767Andrade 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.
PubMed 22348135Armfield 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.
PubMed 19508270Bakri 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.
PubMed 23952266Chung 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.
PubMed 14584861Claffey 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.
PubMed 15330942Eke 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.
PubMed 22935673Eke 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.
PubMed 22420873Erovic 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.
PubMed 26847598Fardal 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.
PubMed 17539717Heitz-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.
PubMed 23574468Khambaty 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.
PubMed 23389686Papapanou 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.
PubMed 22935674Santuchi 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.
PubMed 26461465Sheehan 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.
PubMed 8844930
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nonsurgical Periodontal Treatment in Patients With Social Phobia: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03241277
- Acronym / sponsor ID
- NSPTSP / 33267314.9.0000.0068
- Conditions
- Social Phobia, Periodontal Diseases
- Keywords
- social phobia, anxiety disorders, DSM-IV TR, periodontal disease, non surgical periodontal treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 5 Oct 2017 (estimated)
- Primary completion
- 5 May 2019 (estimated)
- Study completion
- 5 Oct 2019 (estimated)
- First posted
- 7 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Non surgical periodontal treatment
| Arm | Type | Receives |
|---|---|---|
| Social phobia | Experimental | Procedure: Non surgical periodontal treatmentPatients with social phobia with no psychiatric treatment Intervention- non surgical periodontal treatment |
| Social phobia under Psych T | Experimental | Procedure: Non surgical periodontal treatmentPatients with social phobia under psychiatric treatment (Psych T) Intervention- non surgical periodontal treatment |
| Controls | Active comparator | Procedure: Non surgical periodontal treatmentPatients without social phobia Intervention- non surgical periodontal treatment |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non surgical periodontal treatmentAlso: scaling and root planningScaling and root planning that will be performed with manual curettes or ultrasonic instruments | Procedure or surgery | Controls, Social phobia, Social phobia under Psych T |
Primary outcome
Probing depth
Time frame: Change from baseline at 6 months
the distance from the clinical gingival margin to probe tip
1 secondary outcome
Clinical attachment level
Time frame: Change from baseline at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
- Results publication: PubMed 10052767Albandar 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.
- Results publication: PubMed 22348135Andrade 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.
- Results publication: PubMed 19508270Armfield 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.
- Results publication: PubMed 23952266Bakri 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.
- Results publication: PubMed 14584861Chung 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.
- Results publication: PubMed 15330942Claffey 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.
- Results publication: PubMed 22935673Eke 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.
- Results publication: PubMed 22420873Eke 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.
- Results publication: PubMed 26847598Erovic 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.
- Results publication: PubMed 17539717Fardal 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.
- Results publication: PubMed 23574468Heitz-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.
- Results publication: PubMed 23389686Khambaty 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco Lotufo-Neto, PhD study chair
Faculdade de Medicina FMUSP, Universidade de Sao Paulo, SP, Sao Paulo, SP, BR
Ana Cristina Solis, PhD principal investigator
Faculdade de Medicina FMUSP, Universidade de Sao Paulo, SP, Sao Paulo, SP, BR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non surgical periodontal treatment in people with Social Phobia and Periodontal Diseases, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francisco Lotufo-Neto, PhD (+55-11-2661-6988, franciscolotufo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing depth (time frame: Change from baseline at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03241277, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2017.