NCT06912451

Sport Mouthguards: Devices for Preventing Dental Injuries in Sports

Sport Mouthguards: Devices for Preventing Dental and Alveolar Injuries in Sports - A Longitudinal Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Universidade Federal do Rio de Janeiro · Academic / Other
• Sex: All
• Age: 7 Years – 30 Years
• Healthy volunteers: Accepted

Summary

Objective: To evaluate the impact of mouthguards (MG) on acceptability, incidence of soft tissue injuries, periodontal and salivary parameters, as well as on the perception of the body in sports practice (PeCoPes) and on the quality of life of athletes, and evaluate the consequences of use on the characteristics, state of conservation, and biological and physical properties of the MG itself. Methodology: This is a longitudinal study that will include children, adolescents, and adults aged 7 to 30 years who practice sports and require MGs. Sociodemographic data, medical history, dental history, dietary habits, and sports practice data will be collected. Participants will undergo a complete oral clinical examination. Data on knowledge of traumatic dental injuries (TDI) and MGs will also be collected. Before the MG is delivered, immediately after installation, and at 1, 3, and 6 months after use, the following parameters will be evaluated: presence of mucosal injuries, visible plaque index, gingival bleeding index, salivary flow, salivary pH, buffering capacity, and salivary microorganism count. Acceptability will be evaluated before the MG is delivered, immediately after delivery, and at 1, 3, and 6 months after use. PeCoPes and quality of life will be assessed before, 1, 3, and 6 months after MG use. The MG will be evaluated for bacterial contamination, delamination, roughness, dimensional changes related to shape and thickness, color change, and conservation status. The data will be tabulated and analyzed using SPSS 21.0, and appropriate statistical tests (p\<0.05) will be performed according to the study objectives.

Conditions

• Oral Health
• Dental Trauma
• Oral Health Knowledge, Attitude and Practice Among Patients
• Mouth Protectors

Interventions

Type	Name	Description
DEVICE	Sport custom mouthguard	This mouthguard will be made using two 3mm vinyl acetate ethylene sheets in a vacuum machine, following the recommendations for an appropriate mouthguard regarding trauma prevention and patient comfort. The patients will be monitored after 1, 3, and 6 months of using the mouthguard.

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-08-29
• Completion: 2025-12-26
• First posted: 2025-04-04
• Last updated: 2025-04-04

Locations

1 site across 1 country: Brazil