UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035824 |
|---|---|
| Receipt number | R000040813 |
| Scientific Title | Co-relation between daytime somnolence and periodontal diseases- A cross sectional study |
| Date of disclosure of the study information | 2019/02/09 |
| Last modified on | 2019/02/09 16:45:16 |
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Basic information
Public title
Co-relation between daytime somnolence and periodontal diseases- A cross sectional study
Acronym
Co-relation between daytime somnolence and periodontal diseases- A cross sectional study
Scientific Title
Co-relation between daytime somnolence and periodontal diseases- A cross sectional study
Scientific Title:Acronym
Co-relation between daytime somnolence and periodontal diseases- A cross sectional study
Region
| Asia(except Japan) |
Condition
Condition
Daytime somnolence in periodontitis patients
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1.To find out co-relation between day time somnolence and periodontal disease patients.
2.To find out the evidence emerging of periodontal disease as a risk for having a direct or indirect link with day time somnolence.
Basic objectives2
Others
Basic objectives -Others
To find out the evidence emerging of periodontal disease as a risk for having a direct or indirect link with day time somnolence.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Periodontitis is positively correlated with sleep apnea index
Key secondary outcomes
Increase in PPD,CAL,Gingival bleeding index shows a postive corrlation with sleep apnea index
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
| 20 | years-old | < |
Age-upper limit
| 45 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Case definition as per AAP classification (1999)30
2. Age group between 20-45 years (young adults)
Key exclusion criteria
1. Patients with conditions like Diabetes, hypertension, atherosclerosis and other systemic diseases known to affect periodontal status.
2. Pregnant and Lactating Women.
3. Obese patients and patients suffering from metabolic disorders
4. Patients with deleterious habits like alcohol consumption, tobacco habits and any other adverse habits.
6. Patients who have received any surgical or non surgical periodontal therapy in past 6 months.
7. Patients with adenoids and tonsils or recent history of tonsillitis.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Rahul Kumar |
Organization
ITS DENTAL COLLEGE,HOSPITAL AND RESEARCH CENTRE
Division name
Periodontics
Zip code
Address
knowledge park 3,Greater noida, UP, India
TEL
9899767769
rahulchaudhary8787@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rahul Kumar |
Organization
ITS DENTAL COLLEGE,HOSPITAL AND RESEARCH CENTRE
Division name
PERIODONTICS
Zip code
Address
knowledge park 3,Greater noida, UP, India
TEL
9899767769
Homepage URL
rahulchaudhary8787@gmail.com
Sponsor or person
Institute
ITS DENTAL COLLEGE,HOSPITAL AND RESEARCH CENTRE
Institute
Department
Personal name
Funding Source
Organization
ITS DENTAL COLLEGE,HOSPITAL AND RESEARCH CENTRE
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
india
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2019 | Year | 02 | Month | 09 | 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
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 15 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 15 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 15 | Day |
Date analysis concluded
Other
Other related information
1. To find out co-relation between day time somnolence and periodontal disease patients.
2. To find out the evidence emerging of periodontal disease as a risk for having a direct or indirect link with day time somnolence.
Management information
Registered date
| 2019 | Year | 02 | Month | 09 | Day |
Last modified on
| 2019 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040813
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
