UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035824
Receipt No. R000040813
Official scientific title of the study 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study Co-relation between daytime somnolence and periodontal diseases- A cross sectional study
Title of the study (Brief title) 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 Rahul Kumar
Organization ITS DENTAL COLLEGE,HOSPITAL AND RESEARCH CENTRE
Division name Periodontics
Address knowledge park 3,Greater noida, UP, India
TEL 9899767769
Email rahulchaudhary8787@gmail.com

Public contact
Name of contact person Rahul Kumar
Organization ITS DENTAL COLLEGE,HOSPITAL AND RESEARCH CENTRE
Division name PERIODONTICS
Address knowledge park 3,Greater noida, UP, India
TEL 9899767769
Homepage URL
Email rahulchaudhary8787@gmail.com

Sponsor
Institute ITS DENTAL COLLEGE,HOSPITAL AND RESEARCH CENTRE
Institute
Department

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)

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

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 10 Month 29 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040813

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.