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NCT Number: NCT07000435

Comparative Assessment of Thickness Changes in 3D-Printed vs. Custom-Made Mouth Guards for Children in Contact Sports

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

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Key information

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Cairo University

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D printed custom-made mouth guards

Device

Participants in the first group will receive 3D printed custom-made mouth guards

Traditional custom-made mouth guards

Device

Participants in the active comparator arm will receive traditional custom-made mouth guards as an intervention

Primary outcomes

  1. Occlusal thickness changes

    Time frame: 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 outcomes

  1. Cost Efficiency of both mouth guards

    Time frame: 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)

  2. Changes Speech and in Oral Functions

    Time frame: 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.

  3. Knowledge, attitude, and practice (KAP) of children toward mouthguards

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mahmoud Tawfik Elbably, Bachelor's degree of dentistry

CONTACT

[email protected]

+201065873681

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Assessing Thickness Changes Following the Use of 3D-Printed Vs. Custom-Made Mouth Guards to Prevent Traumatic Dental Injuries in Children Practicing Contact Sports: A Randomized Clinical Trial.

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jun 2, 2025
Registry last updated
Jun 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.