Clinical Trial

Sport Mouthguards: Devices for Preventing Dental Injuries in Sports

Recruiting
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Record status
This record was last updated April 4, 2025 (before its estimated August 29, 2025 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT06912451
Lead Sponsor Universidade Federal do Rio de Janeiro
Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ)
Conditions Oral Health, Dental Trauma, Oral Health Knowledge, Attitude and Practice Among Patients, Mouth Protectors
Enrollment 136 participants
Start Date 2024-06-01
Primary Completion 2025-08-29 (estimated)
Study Completion 2025-12-26 (estimated)
Updated on ClinicalTrials.gov 2025-04-04