| CTRI Number |
CTRI/2023/08/056717 [Registered on: 22/08/2023] Trial Registered Prospectively |
| Last Modified On: |
17/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of modified and conventional mouthguard in preventing oral injuries in 8-14 years old children playing skating. |
|
Scientific Title of Study
|
Comparative evaluation of efficacy of modified and conventional mouthguard in preventing orofacial injuries in 8-14 years old children playing skating-A Randomised Control Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivani Sawant |
| Designation |
Post graduate student |
| Affiliation |
Government Dental College and Hospital, Nagpur |
| Address |
Dept. of pediatric dentistry, Government Dental College and
Hospital, Nagpur, Govt. Medical Campus, Hanuman Nagar, Nagpur
Maharashtra
440003
India
Nagpur
MAHARASHTRA
440003
India |
| Phone |
7738893949 |
| Fax |
|
| Email |
shivanisawant322@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shivani Sawant |
| Designation |
Post graduate student |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
Dept. of pediatric dentistry, Government Dental College and
Hospital, Nagpur, Govt. Medical Campus, Hanuman Nagar, Nagpur
MAHARASHTRA
440003
India
Nagpur
MAHARASHTRA
440003
India |
| Phone |
7738893949 |
| Fax |
|
| Email |
shivanisawant322@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ritesh Kalaskar |
| Designation |
Professor |
| Affiliation |
Government Dental College and Hospital, Nagpur |
| Address |
Dept. of pediatric dentistry, Government Dental College and
Hospital, Nagpur, Govt. Medical Campus, Hanuman Nagar, Nagpur
MAHARASHTRA
440003
India
Nagpur
MAHARASHTRA
440003
India |
| Phone |
8550938585 |
| Fax |
|
| Email |
riteshpedo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital, Nagpur |
|
|
Primary Sponsor
|
| Name |
SHIVANI SAWANT |
| Address |
Dept. of pediatric dentistry, Government Dental College and
Hospital, Nagpur, Govt. Medical Campus, Hanuman Nagar, Nagpur
MAHARASHTRA
440003
India |
| Type of Sponsor |
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 Shivani Sawant |
Government Dental College and Hospital, Nagpur |
Department of Pediatric and Preventive Dentistry Room 108 First floor Government Medical Campus, Hanuman nagar Nagpur-440003 maharashtra Nagpur Maharashtra
Nagpur
MAHARASHTRA |
7738893949
shivanisawant322@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Dental College and Hospital, Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Permanent maxillary 1st molars should be erupted to occlusal level. Age should be 8-14 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional mouthguard |
4mm thickness overall both anteriorly and posteriorly of ethylene vinyl acetate sheet(mouthguard) |
| Intervention |
Modified mouthguard |
4mm thickness anteriorly and 2mm thickness posteriorly of ethylene vinyl acetate sheet(mouthguard) |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1.Children in the age group of 8-14 years playing roller skating.
2.Children whose first permanent molars are erupted.
3.Children willing to participate in the study.
4.Children willing to use mouthguard while playing roller skating.
5.Children who have completed 1 year of training period in roller skating.
|
|
| ExclusionCriteria |
| Details |
1.Children whose parents didn’t give the written informed consent to participate in the study.
2.Children with over-retained teeth and crowding.
3.Uncooperative and medically compromised children.
4.Children undergoing orthodontic treatment.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the frequency of fall in children playing roller skating using both type of mouthguard.
2.To evaluate the prevalence of oro-facial injuries(traumatic injuries of tooth, jaw fracture, extraoral and intraoral soft tissue injuries) in children playing roller skating using both type of mouthguard
|
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the knowledge of parents regarding the use of mouthguard in children playing roller skating
2.To evaluate the acceptance of modified and conventional mouthguard by children during roller skating
|
18 months |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/08/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Th This study is a double blinded, parallel group randomised control trial evaluating the efficacy of modified and conventional mouthguard in preventing oro-facial injuries in 8-14 years old children playing skating. Modified mouthguard will be 4mm thick anteriorly and 2mm thick posteriorly whereas conventional mouthguard will be 4mm thick overall. The primary objective is to evaluate the frequency of fall in children playing roller skating us and prevalence of orofacial injuries in children playing skating using both type of mouthguard. The secondary outcome is to assess the knowledge of parents about mouthguard and acceptance of mouthguard by children. |