Sport Mouthguards: Devices for Preventing Dental and Alveolar Injuries in Sports - A Longitudinal Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Acceptability
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Sport Mouthguard
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.
干预措施: Sport custom mouthguard (Device)
结局指标
主要结局
Acceptability
时间窗: Acceptability will be evaluated before the MG is delivered, immediately after delivery, and at 1, 3, and 6 months after use.
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.
Incidence of soft tissue injuries
时间窗: Before the MG is delivered, and at 1, 3, and 6 months after use
The following parameter will be evaluated: presence of mucosal injuries through clinical examinations
Periodontal and salivary parameters
时间窗: Before the MG is delivered, immediately after installation, and at 1, 3, and 6 months after use.
The following parameters will be evaluated: visible plaque index, gingival bleeding index, salivary flow, salivary pH, buffering capacity, and salivary microorganism count.
次要结局
- The perception of the body in sports practice (PeCoPes)(PeCoPes will be assessed before, 1, 3, and 6 months after MG use.)
- The quality of life of athletes(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.(Before the MG is delivered, immediately after installation, and at 1, 3, and 6 months after use.)
研究者
Mariana Pires da Costa
Principal Investigator
Universidade Federal do Rio de Janeiro