An interventional study of Sport custom mouthguard in Oral Health, Dental Trauma and Oral Health Knowledge, Attitude and Practice Among Patients, sponsored by Universidade Federal do Rio de Janeiro. Recruiting at 1 site in Brazil. Open to participants aged 7 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-04.
Sponsored by Universidade Federal do Rio de Janeiro · Not applicable, Interventional, and Prevention
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.
1,573 studies on the registry are indexed under Behavior; 313 are open to participants now.
This study's planned enrollment of 136 is above the median of 120 across 1,197 interventional studies indexed under Behavior.
Browse Behavior studies →Universidade Federal do Rio de Janeiro is the lead sponsor of 123 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
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.
Device: Sport custom mouthguard
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.
Also known as: Mouthguard, Mouth Protector
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.
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
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.
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.
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.
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.
Plan to share: Undecided — The results will be released after the completion of the longitudinal study, which forms part of the responsible reseacher's PhD thesis.
No publications or documents are linked to this record.
Started Jun 2024 (actual). Primary completion is estimated for Aug 2025, 14 months after the start.
Of 741 non-industry interventional studies with no phase under Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 32. This study's planned 14 months is close to that.
Counting every sponsor, half of 757 studies reached it within 13 months; a quarter within 5 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
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