| CTRI Number |
CTRI/2024/04/065258 [Registered on: 05/04/2024] Trial Registered Prospectively |
| Last Modified On: |
05/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To check the link of sleep and Body weight as factors for causing gum disease and other health issues in duty nurses |
|
Scientific Title of Study
|
To evaluate the association of duration of sleep and Body Mass Index as potential risk factors for periodontitis and other co morbidities in duty nurses |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pratima Chaurasia |
| Designation |
Post Graduate Student |
| Affiliation |
JSS Dental College and Hospital |
| Address |
Room 9
Department of Periodontology
JSS Dental College and Hospital
Mysore
Karanji apartment , flat 1, ground floor , unnathi nagar, bannimantap , Mysore 570015
Mysore
KARNATAKA
570015
India |
| Phone |
8939491084 |
| Fax |
|
| Email |
pratzchow@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sheela Kumari Gujjari |
| Designation |
Professor and Head of the department |
| Affiliation |
JSS Dental College and Hospital |
| Address |
ROOM 9
Department of Periodontology
JSS Dental College and Hospital
Mysore
Karanji apartment flat 1 ground floor unnathi nagar bannimantap Mysore 570015
Mysore
KARNATAKA
570015
India |
| Phone |
8939491084 |
| Fax |
|
| Email |
sheelagujjari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pratima Chaurasia |
| Designation |
Post Graduate Student |
| Affiliation |
JSS dental college and hospital |
| Address |
ROOM 9
Department of Periodontology
JSS Dental College and Hospital
Mysore
Karanji apartment , flat 1, ground floor , unnathi nagar, bannimantap , Mysore 570015
Mysore
KARNATAKA
570015
India |
| Phone |
8939491084 |
| Fax |
|
| Email |
pratzchow@gmail.com |
|
|
Source of Monetary or Material Support
|
| jss dental college and hospital ,bannimantap |
| jss medical college, fort mohalla,mysore-570004 |
|
|
Primary Sponsor
|
| Name |
JSS Dental College and Hospital |
| Address |
Mysore, Bannimantap,SSnagara,Mysusu |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pratima Chaurasia |
JSS Medical Hospital |
Department of Nursing , ground floor , JSS Medical College , Agrahara, Fort Mohalla
Mysore - 570004
Mysore
KARNATAKA |
08939491084
pratzchow@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Dental college and Hospital institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY INDIVIDUALS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Participants working as duty nurses in JSS Hospital with experience of 3- 5 years.
2. Participants with atleast 20 teeth
|
|
| ExclusionCriteria |
| Details |
1. Pregnant women
2. Lactating mother
3. Smokers
4. History of medication ( Antibiotics or anti inflammatory , sedative or antidepressant drugs) in 3 months before study.
5. Diabetics
6. Arthritis , Tuberculosis , Gastritis .
7. Acute / Chronic liver diseases
8. Fatty liver diseases
9. Individuals undergone periodontal treatment or on any mouthwashes.
10. In Phase 1 of the study if CRP Level is more than 10mg/dl .
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Primary outcomes measure : To evaluate the association between duration of sleep and Body Mass Index as potential risk factors for periodontitis in duty nurses. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2. Secondary outcome measure: To evaluate the corelation C – Reactive Protein , Lipid Profile (HDL ,LDL , triglyceride ) & Fasting Blood Sugar (FBS) to periodontal status of duty nurses & it’s effect on systemic disease (Diabetes & CVS). |
6 months |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Atypical work schedules cause reduced sleep , leading to drowsiness , fatigue , decline of cognitive performance and health problems among the members of the nursing staff .Poor sleep quality and Insufficient amount of sleep may negatively affect mental and physical functioning of duty nurses.[23] Neglect of Sleep has shown to be associated with increased body mass index which can lead to periodontitis where in the periodontitis may signal systemic inflammation and oxidative stress as locally produced pro inflammatory cytokines from the periodontal tissues can spread to target organs via systemic circulation . .Sleep disturbance and sleep time duration in night shift workers have a relationship with periodontal health status which may be associated with systemic disease.[14] Night shift work contributes to an increased risk of becoming overweight or obese, especially in the abdomen and also contributes to sleep disturbance causing insomnia , short sleep which are associated with increased risk for chronic diseases such as cardiovascular diseases, depression , Type II Diabetes . So evaluation of association between Duration of sleep and Body Mass Index as potential risk factors for periodontitis and other co morbidities in duty nurses at early stage would help in diagnosis and treatment strategies to prevent it at early stage itself. As sleep deprivation induces systemic inflammation or triggers the immune response further ,this study may help to improve the management of lifestyle factors implicated in periodontal disease pathogenesis .This research was carried out to see if there is an association between duration of sleep and Body Mass Index as a risk factor for periodontitis and other co morbidities in duty nurses .The study was done based on clinical studies that have shown that increase in Body mass index and sleep are risk factors for development of periodontitis or worsening of periodontal status .Also, Sleep deprivation can have an effect on systemic co morbidities like diabetes and cardiovascular disease as it may,activate inflammatory processes leading to increased C,Reactive Protein .Duty nurses were taken as participants for the study as they are prone for sleep derivation due to there work schedule .Thus ,this study may help to improve the management of lifestyle factors implicated in periodontal disease pathogenesis to prevent at early stages and helps in establishing the awareness of importance of maintaining good oral health and adequate sleep for a wholesome well being .
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