UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046066 |
|---|---|
| Receipt number | R000052576 |
| Scientific Title | Prevalence of oral diseases and temporomandibular joint disorders among patients with psychiatric disorders in Assir region, Saudi Arabia |
| Date of disclosure of the study information | 2021/11/15 |
| Last modified on | 2021/11/13 16:15:00 |
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Basic information
Public title
Prevalence of oral diseases and temporomandibular joint disorders among patients with psychiatric disorders in Assir region, Saudi Arabia
Acronym
OHS and TMD in PD
Scientific Title
Prevalence of oral diseases and temporomandibular joint disorders among patients with psychiatric disorders in Assir region, Saudi Arabia
Scientific Title:Acronym
OHS and TMD in PD
Region
| Asia(except Japan) |
Condition
Condition
Psychiatric disorders and oral manifestations
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to detect the prevalence of oral manifestations and TMJDs in patients with psychiatric disorders
Basic objectives2
Others
Basic objectives -Others
to study the correlation between the oral manifestations in patients with psychiatric disorders according to: demographic variables (gender), diagnosis of psychiatric disorder, the duration psychotropic medications intake, and the number of psychotropic medications
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of oral diseases in psychiatric disorders patients
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Psychiatric disorders patients institutionalised
Conscious and cooperative
Key exclusion criteria
Non institutionalised patients
unconscious
uncooperative
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Mohammad |
| Middle name | |
| Last name | Kota |
Organization
King Khalid University
Division name
Oral and Maxillofacial Surgery
Zip code
61471
Address
college of dentistry, king khalid university
TEL
0172418084
mqota@kku.edu.sa
Public contact
Name of contact person
| 1st name | ali |
| Middle name | azhar |
| Last name | dawasaz |
Organization
king khalid university
Division name
Diagnostic sciences and oral biology
Zip code
61471
Address
guraiger
TEL
0172418081
Homepage URL
adwasaz@kku.edu.sa
Sponsor or person
Institute
king khalid university
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
king khalid university
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
king khalid university
Address
guraiger
Tel
0172418347
src-cod@kku.edu.sa
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
College of dentistry, king khalid university
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 15 | 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
98
Results
Average number of teeth observed was 21.9 (SD 6.15) while mean DMFT was high 17.08. As the age of the patient increased, DMFT also increased proportionally. The intake of medications had a significant effect (p=0.013) on DMFT. Medications also affected periodontitis stage, gingival and plaque indices significantly (p= 0.004-0.022). However, TMJDs were not significantly associated with the duration of medication intake.
Results date posted
| 2021 | Year | 11 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
all patients were assessed for oral manifestation
Participant flow
regular
Adverse events
none
Outcome measures
oral health assessment was done
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
| 2021 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2021 | Year | 07 | Month | 12 | Day |
Other
Other related information
Oral diseases were diagnosed and correlated with temporomandibular disorders.
Management information
Registered date
| 2021 | Year | 11 | Month | 13 | Day |
Last modified on
| 2021 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052576
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