Sport Mouthguards: Devices for Preventing Dental Injuries in Sports

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-30
SponsorUniversidade Federal do Rio de Janeiro

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

This trial accepts healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Sport custom mouthguard

    Device

    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.

Treatment groups

136 Participants
are divided into 1 treatment group
Group A: Sport MouthguardExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Acceptability

Acceptability will be assessed through a questionnaire on changes in the oral cavity associated with the use of the MG or in the MG itself. This questionnaire was developed by the authors of the study.

Time frame
Acceptability will be evaluated before the MG is delivered, immediately after delivery, and at 1, 3, and 6 months after use.
2

Incidence of soft tissue injuries

The following parameter will be evaluated: presence of mucosal injuries through clinical examinations

Time frame
Before the MG is delivered, and at 1, 3, and 6 months after use
3

Periodontal and salivary parameters

The following parameters will be evaluated: visible plaque index, gingival bleeding index, salivary flow, salivary pH, buffering capacity, and salivary microorganism count.

Time frame
Before the MG is delivered, immediately after installation, and at 1, 3, and 6 months after use.

Secondary outcomes

1

The perception of the body in sports practice (PeCoPes)

The perception of the body in sports practice (PeCoPes) will be assessed through a previously validated questionnaire.

Time frame
PeCoPes will be assessed before, 1, 3, and 6 months after MG use.
2

The quality of life of athletes

The quality of life will be assessed through some previously validated questionnaires.

Time frame
Quality of life will be assessed before, 1, 3, and 6 months after MG use.
3

The consequences of use on the characteristics, state of conservation, and biological and physical properties of the MG itself.

The MG will be evaluated for bacterial contamination, delamination, roughness, dimensional changes related to shape and thickness, color change, and conservation status.

Time frame
Before the MG is delivered, immediately after installation, and at 1, 3, and 6 months after use.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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