About this trial
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.
Eligibility criteria
Qualifiers
Children, adolescents, and adults aged 7 to 30 years, with no systemic health issues, of both genders;
Engaging in sports practice at least twice a week.
Disqualifiers
Presence of cavitated dental caries and/or periodontitis;
Angle Class III malocclusion with negative anterior overjet;
Presence of non-removable prostheses or any other accessory in the upper or lower arch that may interfere with the adaptation of the mouthguard;
Use of medications that may interfere with any salivary parameters;
Trial design
Treatments tested in this trial
- Sport custom mouthguard
Treatment groups
Sponsors and collaborators
Universidade Federal do Rio de Janeiro
Lead sponsor
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Collaborator
Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ)
Collaborator