An interventional study of 3D printed custom-made mouthguards and Traditional custom-made mouthguards in Mouthguard Use, Orofacial Injuries Prevention and 3D Printed Mouthguard, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 8 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by Cairo University · Not applicable, Interventional, and Prevention
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.
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.
76 studies on the registry are indexed under Speech; 49 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 62 interventional studies indexed under Speech.
Browse Speech studies →Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This arm will include participants receiving 3D printed custom mouthguards.
Device: 3D printed custom-made mouthguards
Participants in the second group will receive traditional custom-made mouthguards.
Device: Traditional custom-made mouthguards
Participants in the first group will receive 3D printed custom-made mouthguards
Participants in the active comparator arm will receive traditional custom-made mouthguards as an intervention
Changes Speech and in Oral Functions
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)
Time frame: Six months
Knowledge, attitude, and practice (KAP) of children toward mouthguards
The study will evaluate the knowledge, attitudes, and practices (KAP) of children regarding the use of mouthguards in preventing orofacial injuries during contact sports. Specifically, the study assesses children's awareness of the risks of orofacial injuries, their understanding of mouthguards as a protective measure, and their current usage patterns. Based on a previous study by Vignesh et al. (2023), a structured and well-adapted questionnaire will be given to all participants in both groups at the initial visit.
Time frame: initial visit (the first month)
Cost Efficiency of both mouthguards
This study will also assess the cost efficiency of both types of custom-made mouthguards 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=(Mouthguard A cost- Mouthguard B cost)/(outcome of mouthguard A-Outcome of mouthguard B)
Time frame: one year
Occlusal thickness changes
This study will assess the wear patterns of both types of mouthguards in children participating in contact sports. The wear patterns will be measured by evaluating the thickness reduction of the mouthguards 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 mouthguard, helping to determine which type maintains its protective properties longer under the stress of regular use (Tewari et al., 2024). The mouthguard thickness will be measured at two distinct timepoints (baseline and three months)
Time frame: Three months
Plan to share: Undecided — Individual participant data (IPD) will be shared with qualified researchers upon request, following ethical guidelines and approval from the relevant ethics committee. The data will be anonymized to ensure participant confidentiality and will be made available through a secure data repository.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.