Assessing Changes in Oral Functions and Speech After Using 3D-Printed vs. Custom-made Mouth Guards in Children Practicing Contact Sports: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes Speech and in Oral Functions
研究概览
简要总结
This study aims to compare the effects of traditional and 3D-printed custom-made mouthguards on speech and oral functions in pediatric cases who practice contact sports by evaluating the comfort, fit, and performance of both types of mouthguard fabrication methods. The study will be conducted on 60 children who practice contact sports, and the changes in speech, oral functions, the occlusal thickness of the mouthguards, and the cost efficiency will be assessed over a period of one year.
详细描述
This randomized clinical trial will be conducted at Cairo International Stadium, enrolling healthy children aged 8 to 14 who are actively engaged in contact sports and require mouthguards for protection. Eligible participants must be cooperative and have no history of speech or neurological disorders, orthodontic treatment, or dental anomalies that may affect mouthguard adaptation. After obtaining informed consent from parents, participants will be randomly allocated in a 1:1 ratio into two groups.
Group 1 will receive traditional custom-made mouthguards fabricated from alginate impression material. Group 2 will receive 3D-printed custom-made mouthguards created from digital intraoral scans using CAD/CAM and 3D printing technology. All fittings will be adjusted for comfort, retention, and occlusal balance by the principal investigator.
The primary outcomes include changes in oral functions and speech, assessed using a validated Likert-scale questionnaire adapted from Mat Zainal et al. (2024), administered at baseline, 3 months, and 6 months. Secondary outcomes include evaluating the knowledge, attitude, and practice (KAP) toward mouthguard use using a structured questionnaire (Vignesh et al., 2023), cost efficiency via the incremental cost-effectiveness ratio (ICER), and occlusal thickness changes using an Iwanson caliper. This trial aims to determine whether 3D-printed mouthguards provide superior or equivalent function, comfort, and cost-efficiency compared to traditional methods, potentially advancing the standards of pediatric sports dentistry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Blinding will be applied at multiple levels to minimize bias in this study. Since both the traditional custom-made and 3D-printed mouthguards have a similar appearance, this study will be double-blinded to both the principal investigator and the patients in each study group, thereby reducing expectation bias. A coach, who is not involved in data collection or analysis, will be responsible for distributing the mouthguards to participants, ensuring that neither the principal investigator nor the participants know which type of mouthguard is being used. Additionally, the assessors evaluating speech and oral function will remain blinded to the type of mouthguard. To further ensure objective data analysis and minimize detection and reporting bias, the statistician will also be fully blinded to group allocation.
入排标准
- 年龄范围
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 8-14 years of both ages.
- •Participants actively engaged in contact sports.
- •Children who require mouthguards for protection.
- •Cooperative children.
排除标准
- •Children with a history of speech or neurological disorders affecting oral function
- •Parental refusal to participate.
- •Children currently undergoing orthodontic treatment with fixed appliances.
- •Presence of severe dental anomalies or extensive missing teeth that could interfere with mouthguard adaptation.
结局指标
主要结局
Changes Speech and in Oral Functions
时间窗: Six months
Oral functions, including speaking difficulty, lisping, nausea, bulkiness, and mouth dryness, will be assessed using a validated questionnaire adapted from the study by Mat Zainal et al. (2024). The questionnaire will be administered at three distinct intervals (baseline, 3 months, and six months)
次要结局
- Occlusal thickness changes(Three months)
- Knowledge, attitude, and practice (KAP) of children toward mouthguards(initial visit (the first month))
- Cost Efficiency of both mouthguards(one year)
研究者
yasir mohammed hassan aljadani
Master's Candidate, Department of Pediatric Dentistry, Cairo University
Cairo University