Sport Mouthguards: Devices for Preventing Dental Injuries in Sports

Universidade Federal do Rio de Janeiro

Status: Enrolling

Conditions: Dental Trauma; Oral Health Knowledge, Attitude and Practice Among Patients; Oral Health; Mouth Protectors

Treatments: Device: Sport custom mouthguard

Study type: Interventional

Funder types: Other

Identifiers

NCT06912451

75456123.9.0000.0268

Details and patient eligibility

About

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.

Enrollment: 136 estimated patients

Sex: All

Ages: 7 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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;
• Children, adolescents, and adults with neurological disorders or communication difficulties.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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136 participants in 1 patient group

Sport Mouthguard

Experimental group

Description:

After the initial consultation for clinical examination data collection and anamnesis, an impression of the patient's upper dental arch will be made to create a custom mouthguard. This mouthguard will be made using two 3mm vinyl acetate ethylene sheets, following the recommendations for an appropriate mouthguard regarding trauma prevention and patient comfort.

Treatment:

Device: Sport custom mouthguard