| CTRI Number |
CTRI/2022/08/044528 [Registered on: 01/08/2022] Trial Registered Prospectively |
| Last Modified On: |
29/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of the widespread presence and pattern of Tooth Injuries among Children and Adolescents with Severe to Profound Hearing loss who are reporting to a tertiary care hospital in North India |
|
Scientific Title of Study
|
Prevalence and Pattern of Traumatic Dental Injuries in Children and Adolescents with Severe to Profound Hearing Impairment reporting to a Tertiary Care Centre in North India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AMRITHA R |
| Designation |
JUNIOR RESIDENT (ACAD) |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
DEPTT OF PEDIATRIC AND PREVENTIVE DENTISTRY 6TH FLOOR CDER AIIMS NEWDELHI
E 96 Upper Ground floor Sudarshan Cinema Road Gautham Nagar New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9495335356 |
| Fax |
|
| Email |
dramrithar.jan22@aiims.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MORANKAR RAHUL |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
DEPTT OF PEDIATRIC AND PREVENTIVE DENTISTRY 6TH FLOOR CDER AIIMS NEWDELHI
New Delhi
DELHI
110029
India |
| Phone |
9855501651 |
| Fax |
|
| Email |
captainrahul88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
AMRITHA R |
| Designation |
JUNIOR RESIDENT (ACAD) |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
DEPTT OF PEDIATRIC AND PREVENTIVE DENTISTRY 6TH FLOOR CDER AIIMS NEWDELHI
E 96 Upper Ground floor Sudarshan Cinema Road Gautham Nagar New Delhi
DELHI
110029
India |
| Phone |
9495335356 |
| Fax |
|
| Email |
dramrithar.jan22@aiims.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences New Delhi |
| Address |
All India Institute Of Medical Sciences, Ansari Nagar,New Delhi 110029 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR PREM SAGAR |
AIIMS NEW DELHI |
OPD of Department of Otorhinolaryngology-Head & Neck Surgery, AIIMS, New Delhi
New Delhi
DELHI |
8130069892
sagardrprem@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS NEWDELHI |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H908||Mixed conductive and sensorineuralhearing loss, unspecified, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1.Children, aged 4-18 years of any gender, visiting the OPD of Department of Otorhinolaryngology-Head & Neck Surgery, AIIMS, New Delhi.
2.Patients with severe to profound hearing impairment as established by standard audiometric evaluation.
3.Patients whose parent’s consent for the study.
|
|
| ExclusionCriteria |
| Details |
1.Patients with systemic diseases that can affect the balance and motor coordination.
2.Patients whose parents will not consent for participation in the study.
|
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
1.Prevalence of traumatic dental injuries.
2.Distribution of traumatic dental injuries as per Andreasen’s Classification.
|
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Prevalence and severity of vestibular disturbances in children with severe to profound hearing impairment with TDI.
|
2 years |
|
|
Target Sample Size
|
Total Sample Size="195"
Sample Size from India="195"
Final Enrollment numbers achieved (Total)= "195"
Final Enrollment numbers achieved (India)="195" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study titled "Assessment of prevalence and pattern of traumatic dental injuries among children and adolescents with severe to profound hearing impairment reporting to tertiary care centre in North India" aims at evaluating children and adolescents of the age group 4-18 years who are diagnosed at the ENT OPD of AIIMS ,NewDelhi with severe and profound hearing loss for any form of dental trauma. If an evidence of dental trauma is found, under their consent,they will be subjected to a vestibular function assessment to look for any ear associated balance issues.Hence, the prevalence of dental trauma in the above mentioned criteria of patients and whether any associated balance disorders are also present in those patients can be evaluated.
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