| CTRI Number |
CTRI/2021/05/033877 [Registered on: 31/05/2021] Trial Registered Prospectively |
| Last Modified On: |
31/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Association of SDB with OHRQoL in six to twelve year old children: a coss-sectional study |
|
Scientific Title of Study
|
Association of sleep disordered breathing with oral health related quality of life in six to twelve year old children: a cross-sectional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Surbhi Sharma |
| Designation |
Post Graduate student |
| Affiliation |
Y.M.T Dental college and hospital |
| Address |
Room number 21, second floor, Y.M.T Dental college and Hospital, sector 4, Kharghar, Navi Mumbai, Raigarh
Room number 21, second floor , Y.M.T Dental college and Hospital, sector 4, Kharghar, Navi Mumbai, Raigarh
Raigarh
MAHARASHTRA
410210
India |
| Phone |
08369313383 |
| Fax |
|
| Email |
awesome.surbhi23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amar Katre |
| Designation |
Professor and Head of the department |
| Affiliation |
Y.M.T dental college and hospital |
| Address |
Room number 21, second floor, Y.M.T Dental college and Hospital, sector 4, Kharghar, Navi Mumbai, Raigarh
Room number 21, second floor, Y.M.T Dental college and Hospital, sector 4, Kharghar, Navi Mumbai, Raigarh
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9821540186 |
| Fax |
|
| Email |
amar_katre@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amar Katre |
| Designation |
Professor and Head of the department |
| Affiliation |
Y.M.T dental college and hospital |
| Address |
Room number 21, second floor, Y.M.T Dental college and Hospital, sector 4, Kharghar, Navi Mumbai, Raigarh
Room number 21, second floor, Y.M.T Dental college and Hospital, sector 4, Kharghar, Navi Mumbai, Raigarh
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9821540186 |
| Fax |
|
| Email |
amar_katre@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Surbhi sharma |
| Address |
Room number 21, second floor department of pediatric and preventive dentistry, Y.M.T Dental College and Hospital, sector 4, Kharghar Navi Mumbai, Raigarh, MAHARASHTRA- 410210, INDIA |
| Type of Sponsor |
Other [Self support] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Amar Katre |
Room number 21, second floor, Y.M.T Dental college and Hospital, sector 4, Kharghar, Navi Mumbai, Raigarh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Surbhi Sharma |
Y.M.T dental college and hospital |
Room number 21, second floor department of pediatric and preventive dentistry, Y.MT dental college and hospital, sector 4 Kharghar, Navi Mumbai Raigarh MAHARASHTRA
Raigarh
MAHARASHTRA |
8368313383
awesome.surbhi23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee YMT dental college and hospital Kharghar Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children between six to twelve years of age. |
|
| ExclusionCriteria |
| Details |
1. Children who are physically or mentally handicapped and/or medically compromised.
2. Children undergoing or completed orthodontic treatment.
3. Children with developmental anomalies lie cleft lip and/or palate etc.
4. Children in whom tonsillectomy/adenoidectomy has been performed.
5. Children whose parents refuse to give consent.
6. Children with mixed dentition in which the index teeth for OHI-S have not erupted.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| SDB and OHRQOL |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Caries status, caries risk, developing malocclusion, oral hygiene and gender |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
05/06/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sleep and wake states are characterized by distinct hormonal patterns that exert potential significant influences on metabolism and hence disturbance in sleep may have a significant impact on general and oral health. In this study 150 children will be Recruited for assessing sleep disordered breathing and OHRQoL by examination and through questionnaire. Thereby association of sleep disordered breathing and OHRQoL will be assessed. |