| CTRI Number |
CTRI/2023/10/059016 [Registered on: 23/10/2023] Trial Registered Prospectively |
| Last Modified On: |
17/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Is there any relation between mouth breathing and sleep bruxism in 3 to 12 year old children |
|
Scientific Title of Study
|
ASSOCIATION OF MOUTH BREATHING AND PROBABLE SLEEP BRUXISM IN
THREE- TO TWELVE-YEAR-OLD CHILDREN: A CROSS SECTIONAL STUDY. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Apurva Marsale |
| Designation |
Post graduate |
| Affiliation |
Y.M.T Dental college and hospital kharghar , navi Mumbai |
| Address |
503 shah royales sector 2, kharghar navi mumbai 410210
Room no. 21 department of pediatric and preventive dentistry sector 4 Kharghar Raigarh.
Mumbai (Suburban)
MAHARASHTRA
410210
India |
| Phone |
9082330822 |
| Fax |
|
| Email |
apurvamarsale21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amar Katre |
| Designation |
post graduate guide |
| Affiliation |
Y.M.T Dental college and hospital kharghar , navi Mumbai |
| Address |
21, Department of pediatric and preventive dentistry, 2nd floor, Y.M.T Dental college,sector 4, Navi Mumbai 410210
Room no. 21 department of pediatric and preventive dentistry sector 4 Kharghar Raigarh.
Mumbai (Suburban)
MAHARASHTRA
410210
India |
| Phone |
9821540186 |
| Fax |
|
| Email |
amar_katre@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Apurva Marsale |
| Designation |
Post graduate |
| Affiliation |
Y.M.T Dental college and hospital kharghar , navi Mumbai |
| Address |
503 shah royales sector 2, kharghar navi mumbai 410210
Room no. 21 department of pediatric and preventive dentistry sector 4 Kharghar Raigarh.
Mumbai (Suburban)
MAHARASHTRA
410210
India |
| Phone |
9082330822 |
| Fax |
|
| Email |
apurvamarsale21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Y.M.T Dental college and hospital, Navi Mumbai, Maharashtra 410210 |
|
|
Primary Sponsor
|
| Name |
Dr Apurva Sanjay Marsale |
| Address |
302, Panchashil hill view, heaven park lane no. 6, wanowri, Pune 411060 |
| Type of Sponsor |
Other [Other- Self funded] |
|
|
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 Apurva Marsale |
21, Department of Pediatric and Preventive dentistry, 2nd floor, Y.M.T dental college and hospital |
21,Department of pediatric and preventive dentistry institutional area,sector 4,Kharghar, 410210 Raigarh MAHARASHTRA
Raigarh
MAHARASHTRA |
9082330822
apurvamarsale21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committe,Y.M.T Dental college and hospital, Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
MOUTH BRATHING AND BRUXISM |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Healthy children in the age range of three to twelve years. |
|
| ExclusionCriteria |
| Details |
1. Children with physical, mental and medical conditions that may
hamper data collection.
2. Children with acute upper respiratory tract infection.
3. Parents who refuse to give consent. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| ASSOCIATION BETWEEN MOUTH BREATHING AND PROBABLE SLEEP BRUXISM |
At baseline only, no further recall |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. tonsillar size & association with probable sleep bruxism in
three- to twelve-year-old children.
2. the tongue mobility and its association with probable sleep
bruxism in three- to twelve-year-old children. |
At baseline only, no further recall |
|
|
Target Sample Size
|
Total Sample Size="213"
Sample Size from India="213"
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)
|
10/11/2023 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Email- apurvamarsale21@gmail.com
- For how long will this data be available start date provided 01-01-2024 and end date provided 01-01-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
In our study we plan to assess and compare 1. To assess mouth breathing in three- to twelve-year-old children. 2. To assess probable sleep bruxism in three- to twelve-year-old children. 3. To assess the association of mouth breathing and probable sleep bruxism in three- to twelve-year-old children. 4. To assess tonsillar size and its association with probable sleep bruxism in three- to twelve-year-old children. 5. To assess the tongue mobility and its association with probable sleep bruxism in three- to twelve-year-old children. |