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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000046066
Receipt No. 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

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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
Email 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
Email adwasaz@kku.edu.sa

Sponsor
Institute king khalid university
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052576

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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