UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050995 |
|---|---|
| Receipt number | R000058133 |
| Scientific Title | A study on the effects of pharmacotherapy and psychosocial treatment of somatic symptom disorders in the orofacial region (e.g. burning mouth syndrome, temporomandibular disorder, and persistent idiopathic facial pain) using personality tendencies, nurturing experiences, and support from others as indicators. |
| Date of disclosure of the study information | 2023/05/07 |
| Last modified on | 2024/05/08 16:52:43 |
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Basic information
Public title
A study on the effects of pharmacotherapy and psychosocial treatment of somatic symptom disorders in the orofacial region (e.g. burning mouth syndrome, temporomandibular disorder, and persistent idiopathic facial pain) using personality tendencies, nurturing experiences, and support from others as indicators.
Acronym
A study on the effects of pharmacotherapy and psychosocial treatment of somatic symptom disorders in the orofacial region.
Scientific Title
A study on the effects of pharmacotherapy and psychosocial treatment of somatic symptom disorders in the orofacial region (e.g. burning mouth syndrome, temporomandibular disorder, and persistent idiopathic facial pain) using personality tendencies, nurturing experiences, and support from others as indicators.
Scientific Title:Acronym
A study on the effects of pharmacotherapy and psychosocial treatment of somatic symptom disorders in the orofacial region.
Region
| Japan |
Condition
Condition
somatic symptom disorders in the orofacial region
Classification by specialty
| Psychiatry | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of pharmacotherapy and psychosocial treatment for patients with somatic symptom disorders in the orofacial region, using personality tendencies, nurturing experiences, and support from others as indicators.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain (using Visual Analogue Scale; 0 weeks, 12 weeks, 6 months, and annually thereafter)
Key secondary outcomes
Short-Form McGill Pain Questionnaire: SF-MPQ, Beck Depression Inventory: BDI, Hamilton Depression Rating Scale: HDRS, the Short Form-8: SF-8, The Mini-International Neuropsychiatric Interview: MINI, Global Assessment of Functioning: GAF, Temperament and Character Inventory: TCI, Parental Bonding Instrument: PBI, Social Support Questionnaire: SSQ, Perceived Vulnerability to Disease: PVD
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who visit the Liaison Outpatient Clinic of Aichi Gakuin University Dental Hospital and diagnosed with somatic symptom disorders in the orofacial region by dentists and psychiatrists.
Key exclusion criteria
Patients who have the history of psychotic disorders or clinically overt dementia.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Nakayama |
Organization
School of Dentistry, Aichi Gakuin University
Division name
Department of Oral and Maxillofacial Surgery
Zip code
4648651
Address
2-11 Suemori-dori, Chikusa-ku, Nagoya
TEL
+81-52-759-2111
mi_ito1013@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kimura |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
+81-52-744-2282
Homepage URL
kimura.hiroyuki.s7@f.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Oral and Maxillofacial Surgery, School of Dentistry, Aichi Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethical Review Committee of Aichi Gakuin University School of Dentistry
Address
2-11 Suemori-dori, Chikusa-ku, Nagoya
Tel
+81527592111
honda-m@dpc.agu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2005 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2005 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2005 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Subjects are administered the primary and secondary endpoint measures at 0 weeks, 12 weeks, 6 months, and annually thereafter.
Management information
Registered date
| 2023 | Year | 05 | Month | 07 | Day |
Last modified on
| 2024 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058133
