Mouthguard Use Orofacial Injuries Prevention 3D Printed Mouthguard Traditional Custom-made Mouthguard Occlusal Thickness Changes
Conditions
Keywords
3D printed mouthguard traditional custom-made mouthguard occlusal thickness CAD/CAM 3D printer Children Pediatric Dentistry Contact sports thickness changes
Brief summary
This study aims to compare changes in the thickness of traditional and 3D-printed custom mouth guards in pediatric athletes who participate in contact sports. Specifically, it will assess the occlusal thickness changes between both types of mouth guards. The research will involve 56 children engaged in contact sports, and the evaluation will cover occlusal thickness, speech, oral functions, and cost-effectiveness over the course of one yea
Detailed description
This randomized clinical trial will be conducted at Cairo International Stadium, involving healthy children aged 8 to 14 who actively participate in contact sports and require mouthguards for safety. Participants must be physically fit and cooperative. With parental consent, they will be randomly assigned in a 1:1 ratio to one of two groups: Group 1: Receives traditional custom-made mouthguards made from alginate impressions. Group 2: Receives 3D-printed custom-made mouthguards created using digital intraoral scans and CAD/CAM 3D printing technology. Primary Outcome: Changes in occlusal thickness will be measured at specific reference points on the occlusal surface using an Iwanson caliper. Measurements will be taken at baseline and again after 3 months.(7. Rossi, G. D., Lisman, P., & Leyte-Vidal, M. A. (2007)) Secondary Outcomes: Knowledge, attitudes, and practices (KAP) related to mouthguard use, assessed via a structured questionnaire (Vignesh et al., 2023). Cost-efficiency, evaluated using the incremental cost-effectiveness ratio (ICER). after one year. Changes in oral functions and speech, measured with a validated Likert-scale questionnaire (Mat Zainal et al., 2024), administered at baseline, 3 months, and 6 months. The trial aims to assess whether 3D-printed mouthguards offer equal or better protection against orofacial injuries compared to traditional mouthguards
Interventions
DEVICE3D printed custom-made mouth guards
Participants in the first group will receive 3D printed custom-made mouth guards
DEVICETraditional custom-made mouth guards
Participants in the active comparator arm will receive traditional custom-made mouth guards as an intervention
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to one of two groups: one group will receive traditional custom-made mouthguards, and the other will receive 3D-printed custom-made mouthguards. Each participant will remain in their assigned group throughout the study period, and outcomes will be assessed independently for each group.
Eligibility
Sex/Gender
ALL
Age
8 Years to 14 Years
Healthy volunteers
Yes
Inclusion criteria
Athletic children who play contact sports Age ranges between 8-14 years. Compliance: participants must agree to use mouth guard consistently Parental consent Physically fit
Exclusion criteria
Athletic children who play contact sports Age ranges between 8-14 years. Compliance: participants must agree to use mouth guard consistently Parental consent Physically fit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occlusal thickness changes | Three months | This study will assess the wear patterns of both types of mouth guards in children participating in contact sports. The wear patterns will be measured by evaluating the thickness changes of the mouth guards over time using an Iwanson caliper (measured in millimeters, mm). This method will provide quantitative data on the durability and wear resistance of each type of mouth guard, helping to determine which type maintains its protective properties longer under the stress of regular use. The mouth guard thickness will be measured at two distinct time points (baseline and three months) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost Efficiency of both mouth guards | One year | This study will also assess the cost efficiency of both types of custom-made mouth guards by calculating the cost per unit, using the U.S Dollar (USD) as the unit of measurement. The incremental cost effectiveness ratio will be calculated after one year. The following equation will be used to measure the incremental cost-effectiveness ratio (Sadatsafavi et al., 2009): ICER=(Mouth guard A cost- Mouth guard B cost)/(outcome of mouth guard A-Outcome of mouth guard B) |
| Changes Speech and in Oral Functions | Six months | Oral functions, such as speaking difficulty, lisping, nausea, bulkiness, and mouth dryness, will be evaluated using a validated questionnaire adapted from the study by Mat Zainal et al. (2024). This questionnaire will be administered at three separate time points: baseline, 3 months, and 6 months. |
| Knowledge, attitude, and practice (KAP) of children toward mouthguards | Initial visit | The study will assess the knowledge, attitudes, and practices (KAP) of children regarding mouth guard use for preventing orofacial injuries during contact sports. It will focus on their awareness of the risks associated with orofacial injuries, their understanding of mouth guards as a protective tool, and their current usage habits. A structured questionnaire, adapted from Vignesh et al. (2023), will be administered to all participants in both groups during the initial visit. |
Countries
Egypt
Contacts
Primary ContactMahmoud Tawfik Elbably, Bachelor's degree of dentistry
Outcome results
None listed