Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
| Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ) | UNKNOWN |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sport Mouthguard | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Acceptability will be evaluated before the MG is delivered, immediately after delivery, and at 1, 3, and 6 months after use. |
| Incidence of soft tissue injuries | The following parameter will be evaluated: presence of mucosal injuries through clinical examinations | Before the MG is delivered, and at 1, 3, and 6 months after use |
| 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. | Before the MG is delivered, immediately after installation, and at 1, 3, and 6 months after use. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | PeCoPes will be assessed before, 1, 3, and 6 months after MG use. |
| The quality of life of athletes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mariana Pires da Costa, PhD Student | Contact | +552139382101 | maripires123@hotmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal do Rio de Janeiro | Recruiting | Rio de Janeiro | Rio de Janeiro | 21941-971 | Brazil |
The results will be released after the completion of the longitudinal study, which forms part of the responsible reseacher's PhD thesis.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009064 | Mouth Protectors |
| ID | Term |
|---|---|
| D011313 | Preventive Dentistry |
| D003813 | Dentistry |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
The quality of life will be assessed through some previously validated questionnaires. |
| Quality of life will be assessed before, 1, 3, and 6 months after MG use. |
| 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. | Before the MG is delivered, immediately after installation, and at 1, 3, and 6 months after use. |
| D000067393 |
| Personal Protective Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |