Mouthguard Use Orofacial Injuries Prevention 3D Printed Mouthguard Traditional Custom-made Mouthguard Occlusal Thickness ChangesNCT07000435
Comparative Assessment of Thickness Changes in 3D-Printed vs. Custom-Made Mouth Guards for Children in Contact Sports
A study testing 3D printed custom-made mouth guards and Traditional custom-made mouth guards in people with Mouthguard Use Orofacial Injuries Prevention 3D Printed Mouthguard Traditional Custom-made Mouthguard Occlusal Thickness Changes, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Mouthguard Use Orofacial Injuries Prevention 3D Printed Mouthguard Traditional Custom-made Mouthguard Occlusal Thickness Changes
- What is being tested?
- 3D printed custom-made mouth guards and Traditional custom-made mouth guards
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mahmoud Tawfik Elbably, Bachelor's degree of dentistry contact
About this study
Official 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.
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
Read the 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
- Being tested
- 3D printed custom-made mouth guards, Traditional custom-made mouth guards
- Keywords
- 3D printed mouthguard traditional custom-made mouthguard occlusal thickness CAD/CAM 3D printer Children Pediatric Dentistry Contact sports thickness changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed custom-made mouth guardsDevice
Participants in the first group will receive 3D printed custom-made mouth guards
Traditional custom-made mouth guardsDevice
Participants in the active comparator arm will receive traditional custom-made mouth guards as an intervention
| Study group | Role | What they receive |
|---|---|---|
| 3D printed custom-made mouth guards | Experimental | This arm will include participants receiving 3D printed custom mouth guards Receives: Device: 3D printed custom-made mouth guards |
| Traditional custom-made mouthguards | Active comparator | Participants in the second group will receive traditional custom-made mouth guards Receives: Device: Traditional custom-made mouth guards |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occlusal thickness changes
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)
Measured: Three months
Secondary outcomes (3)
Cost Efficiency of both mouth guards
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)
Measured: One year
Changes Speech and in Oral Functions
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.
Measured: Six months
Knowledge, attitude, and practice (KAP) of children toward mouthguards
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.
Measured: Initial visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2025
- Study startAug 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Mouthguard Use Orofacial Injuries Prevention 3D Printed Mouthguard Traditional Custom-made Mouthguard Occlusal Thickness ChangesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Tawfik Mohamed, Cairo University
- Investigators
- Gihan Mohamed Abuelniel, Doctoral Degree (Professor), Study director, Cairo UniversityPassant Nagi, Master's Degree, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000435
- Sponsor's protocol ID
- Thickness of Mouthguards
- Status last verified
- May 2025
- First submitted
- 24 May 2025
- Last updated
- 2 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Abbott PV, Tewari N, O'Connell AC, Mills SC, Stasiuk H, Roettger M, Levin L. The International Association of Dental Traumatology (IADT) and the Academy for Sports Dentistry (ASD) guidelines for prevention of traumatic dental injuries: Part 3: Mouthguards for the prevention of dental and oral trauma. Dent Traumatol. 2024 Feb;40 Suppl 1:7-9. doi: 10.1111/edt.12925.
PubMed 38363704Mat Zainal MK, Liew AKC, Abdullah D, Soo E, Abdul Hamid B, Ramlee RAM. Changes in oral functions and speech when using custom-fitted mouthguards: An uncontrolled before-and-after study. Dent Traumatol. 2024 Aug;40(4):460-469. doi: 10.1111/edt.12939. Epub 2024 Mar 8.
PubMed 38459669Singh G, Garg S, Damle SG, Dhindsa A, Kaur A, Singla S. A study of sports related occurrence of traumatic orodental injuries and associated risk factors in high school students in north India. Asian J Sports Med. 2014 Sep;5(3):e22766. doi: 10.5812/asjsm.22766. Epub 2014 Aug 28.
PubMed 25520762Tanaka Y, Maeda Y, Yang TC, Ando T, Tauchi Y, Miyanaga H. Prevention of orofacial injury via the use of mouthguards among young male rugby players. Int J Sports Med. 2015 Mar;36(3):254-61. doi: 10.1055/s-0034-1390498. Epub 2014 Oct 20.
PubMed 25329428Avgerinos S, Stamos A, Nanussi A, Engels-Deutsch M, Cantamessa S, Dartevelle JL, Unamuno E, Del Grosso F, Fritsch T, Crouzette T, Striegel M, Sanchez CC, Okshah A, Tzimpoulas N, Naka O, Kouveliotis G, Tzoutzas I, Zoidis P, Synodinos F, Loizos E, Tasopoulos T, Haughey J, Rahiotis C. Position Statement and Recommendations for Custom-Made Sport Mouthguards. Dent Traumatol. 2025 Jun;41(3):246-251. doi: 10.1111/edt.13019. Epub 2024 Nov 22.
PubMed 39578680Sadatsafavi M, Marra CA, Ayas NT, Stradling J, Fleetham J. Cost-effectiveness of oral appliances in the treatment of obstructive sleep apnoea-hypopnoea. Sleep Breath. 2009 Aug;13(3):241-52. doi: 10.1007/s11325-009-0248-4. Epub 2009 Feb 20.
PubMed 19229577
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07000435
- Acronym / sponsor ID
- Thickness of Mouthguards
- Keywords
- 3D printed mouthguard traditional custom-made mouthguard occlusal thickness CAD/CAM 3D printer Children Pediatric Dentistry Contact sports thickness changes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 2 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 3D printed custom-made mouth guards | Experimental | Device: 3D printed custom-made mouth guardsThis arm will include participants receiving 3D printed custom mouth guards |
| Traditional custom-made mouthguards | Active comparator | Device: Traditional custom-made mouth guardsParticipants in the second group will receive traditional custom-made mouth guards |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D printed custom-made mouth guardsParticipants in the first group will receive 3D printed custom-made mouth guards | Device | 3D printed custom-made mouth guards |
| Traditional custom-made mouth guardsParticipants in the active comparator arm will receive traditional custom-made mouth guards as an intervention | Device | Traditional custom-made mouthguards |
Primary outcome
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)
3 secondary outcomes
Cost Efficiency of both mouth guards
Time frame: One year
Changes Speech and in Oral Functions
Time frame: Six months
Knowledge, attitude, and practice (KAP) of children toward mouthguards
Time frame: Initial visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2025.
- Background: PubMed 38363704Abbott PV, Tewari N, O'Connell AC, Mills SC, Stasiuk H, Roettger M, Levin L. The International Association of Dental Traumatology (IADT) and the Academy for Sports Dentistry (ASD) guidelines for prevention of traumatic dental injuries: Part 3: Mouthguards for the prevention of dental and oral trauma. Dent Traumatol. 2024 Feb;40 Suppl 1:7-9. doi: 10.1111/edt.12925.
- Background: PubMed 38459669Mat Zainal MK, Liew AKC, Abdullah D, Soo E, Abdul Hamid B, Ramlee RAM. Changes in oral functions and speech when using custom-fitted mouthguards: An uncontrolled before-and-after study. Dent Traumatol. 2024 Aug;40(4):460-469. doi: 10.1111/edt.12939. Epub 2024 Mar 8.
- Background: PubMed 25520762Singh G, Garg S, Damle SG, Dhindsa A, Kaur A, Singla S. A study of sports related occurrence of traumatic orodental injuries and associated risk factors in high school students in north India. Asian J Sports Med. 2014 Sep;5(3):e22766. doi: 10.5812/asjsm.22766. Epub 2014 Aug 28.
- Background: PubMed 25329428Tanaka Y, Maeda Y, Yang TC, Ando T, Tauchi Y, Miyanaga H. Prevention of orofacial injury via the use of mouthguards among young male rugby players. Int J Sports Med. 2015 Mar;36(3):254-61. doi: 10.1055/s-0034-1390498. Epub 2014 Oct 20.
- Background: PubMed 39578680Avgerinos S, Stamos A, Nanussi A, Engels-Deutsch M, Cantamessa S, Dartevelle JL, Unamuno E, Del Grosso F, Fritsch T, Crouzette T, Striegel M, Sanchez CC, Okshah A, Tzimpoulas N, Naka O, Kouveliotis G, Tzoutzas I, Zoidis P, Synodinos F, Loizos E, Tasopoulos T, Haughey J, Rahiotis C. Position Statement and Recommendations for Custom-Made Sport Mouthguards. Dent Traumatol. 2025 Jun;41(3):246-251. doi: 10.1111/edt.13019. Epub 2024 Nov 22.
- Background: PubMed 19229577Sadatsafavi M, Marra CA, Ayas NT, Stradling J, Fleetham J. Cost-effectiveness of oral appliances in the treatment of obstructive sleep apnoea-hypopnoea. Sleep Breath. 2009 Aug;13(3):241-52. doi: 10.1007/s11325-009-0248-4. Epub 2009 Feb 20.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mahmoud Tawfik Elbably, Bachelor's degree of dentistry contact
Gihan Mohamed Abuelniel, Doctoral Degree (Professor) study director
Cairo University
Passant Nagi, Master's Degree study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printed custom-made mouth guards and Traditional custom-made mouth guards in people with Mouthguard Use Orofacial Injuries Prevention 3D Printed Mouthguard Traditional Custom-made Mouthguard Occlusal Thickness Changes, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Tawfik Elbably, Bachelor's degree of dentistry (+201065873681, mahmoud.elbably@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occlusal thickness changes (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07000435, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2025.