UMIN-CTR Clinical Trial

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