Comparison of modified and conventional mouthguard in preventing oral injuries in 8-14 years old children playing skating.

Phase 3

Not yet recruiting

• Conditions: Permanent maxillary 1st molars should be erupted to occlusal level. Age should be 8-14 years

• Registration Number: CTRI/2023/08/056717
• Lead Sponsor: SHIVANI SAWANT

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-08-17
• Study Start: 2023-08-31

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To evaluate the frequency of fall in children playing roller skating using both type of mouthguard.	18 months
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Government Dental College and Hospital, Nagpur; 🇮🇳 Nagpur, MAHARASHTRA, India

Government Dental College and Hospital, Nagpur

🇮🇳Nagpur, MAHARASHTRA, India

Dr Shivani Sawant

Principal investigator

7738893949

shivanisawant322@gmail.com