Mouthguard UseMouthguardsNCT06972823
Impact of 3D-Printed and Custom Mouthguards on Speech and Oral Functions in Children Practicing Contact Sports
A study testing 3D printed custom-made mouthguards and Traditional custom-made mouthguards in people with Mouthguard Use and Orofacial Injuries Prevention, run by Cairo University at 1 site in Egypt.
Trial summary
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. 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
- What is being tested?
- 3D printed custom-made mouthguards and Traditional custom-made mouthguards
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 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
- Children aged 8-14 years of both ages.
- Participants actively engaged in contact sports.
- Children who require mouthguards for protection.
- Cooperative children.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yasir M Aljadani, Bachelor's degree of dentistry contact
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Mouthguard Use, Orofacial Injuries Prevention, 3D Printed Mouthguard, Traditional Custom-made Mouthguard, Speech and Oral Functions
- Being tested
- 3D printed custom-made mouthguards, Traditional custom-made mouthguards
- Keywords
- 3D printed mouthguard, traditional custom-made mouthguard, speech, oral functiions, CAD/CAM, 3D printer, Children, Pediatric Dentistry, Contact sports, speaking
- Medical subject headings
- Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed custom-made mouthguardsDevice
Participants in the first group will receive 3D printed custom-made mouthguards
Traditional custom-made mouthguardsDevice
Participants in the active comparator arm will receive traditional custom-made mouthguards as an intervention
| Study group | Role | What they receive |
|---|---|---|
| 3D printed custom-made mouthguards | Experimental | This arm will include participants receiving 3D printed custom mouthguards. Receives: Device: 3D printed custom-made mouthguards |
| Traditional custom-made mouthguards | Active comparator | Participants in the second group will receive traditional custom-made mouthguards. Receives: Device: Traditional custom-made mouthguards |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Six months
Secondary outcomes (3)
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.
Measured: 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)
Measured: 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)
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study startAug 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Mouthguard UseStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yasir mohammed hassan aljadani, Cairo University
- Investigators
- Gihan M Abuelniel, Doctoral Degree (Professor), Study director, Cairo UniversityPassant Nagi, Master's Degree, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972823
- Sponsor's protocol ID
- Custom Mouthguards and Speech
- Acronym
- Mouthguards
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 15 May 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
Vignesh, T. S., Chinni, S. K., Anumula, L., Sannapureddy, S., Kumar, Y. P., & Rohith, V. V. S. (2023). Knowledge, Attitudes, and Practices of Mouth Guards in the Prevention of Orofacial Injuries in Sports Persons-A Cross-sectional Study. Journal of Interdisciplinary Dentistry, 13(2), 84-89.
Tewari N, Kahler B, Srivastav S, Goel S. How far have we come? A historic scoping review of dental traumatology literature. Dent Traumatol. 2022 Oct;38(5):345-355. doi: 10.1111/edt.12760. Epub 2022 May 25.
PubMed 35612349Tanaka 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 25329428Sousa AM, Pinho AC, Messias A, Piedade AP. Present Status in Polymeric Mouthguards. A Future Area for Additive Manufacturing? Polymers (Basel). 2020 Jul 3;12(7):1490. doi: 10.3390/polym12071490.
PubMed 32635307Singh 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 25520762Sadatsafavi 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 19229577Roberts HW. Sports mouthguard overview: Materials, fabrication techniques, existing standards, and future research needs. Dent Traumatol. 2023 Apr;39(2):101-108. doi: 10.1111/edt.12809. Epub 2022 Nov 27.
PubMed 36436198Ntovas P, Ladia O, Kois JC, Rahiotis C, Revilla-Leon M. Digital workflow for the fabrication of custom-fit additively manufactured sports mouthguards with balanced occlusion using an optical jaw tracking system: A dental technique. J Prosthet Dent. 2025 Nov;134(5):1536-1541. doi: 10.1016/j.prosdent.2024.07.021. Epub 2024 Aug 22.
PubMed 39174379Mordini L, Lee P, Lazaro R, Biagi R, Giannetti L. Sport and Dental Traumatology: Surgical Solutions and Prevention. Dent J (Basel). 2021 Mar 23;9(3):33. doi: 10.3390/dj9030033.
PubMed 33806915Mat 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 38459669Green JI. The Role of Mouthguards in Preventing and Reducing Sports-related Trauma. Prim Dent J. 2017 May 1;6(2):27-34. doi: 10.1308/205016817821281738.
PubMed 28668098Dias Goncalves VP, Fontes Vieira CM, Colorado Lopera HA. The production and materials of mouthguards: Conventional vs additive manufacturing - A systematic review. Heliyon. 2024 Jul 8;10(14):e34294. doi: 10.1016/j.heliyon.2024.e34294. eCollection 2024 Jul 30.
PubMed 39092246Dolic O, Obradovic M, Kojic Z, Knezevic N, Trtic N, Veselinovic V, Arapovic-Savic M, Umicevic-Davidovic M, Krcic V. Traumatic Dental Injuries in Children and Adolescents from a Major Dental Clinic in Bosnia and Herzegovina: A 5-Year Retrospective Study. Medicina (Kaunas). 2024 Nov 8;60(11):1843. doi: 10.3390/medicina60111843.
PubMed 39597028Del Rossi G, Lisman P, Signorile J. Fabricating a better mouthguard. Part II: the effect of color on adaptation and fit. Dent Traumatol. 2008 Apr;24(2):197-200. doi: 10.1111/j.1600-9657.2007.00570.x.
PubMed 18352924De Queiroz, T. S., da Cruz, B. S., Demachkia, A. M. M., Borges, A. L. S., Tribst, J. P. M., & Paes Junior, T. J. d. A. (2023). Ergonomic sports mouthguards: A narrative literature review and future perspectives. Applied Sciences, 13(20), 11353.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06972823
- Acronym / sponsor ID
- Mouthguards / Custom Mouthguards and Speech
- Conditions
- Mouthguard Use, Orofacial Injuries Prevention, 3D Printed Mouthguard, Traditional Custom-made Mouthguard, Speech and Oral Functions
- Keywords
- 3D printed mouthguard, traditional custom-made mouthguard, speech, oral functiions, CAD/CAM, 3D printer, Children, Pediatric Dentistry
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 15 May 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 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.
Detailed description
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.
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 mouthguards | Experimental | Device: 3D printed custom-made mouthguardsThis arm will include participants receiving 3D printed custom mouthguards. |
| Traditional custom-made mouthguards | Active comparator | Device: Traditional custom-made mouthguardsParticipants in the second group will receive traditional custom-made mouthguards. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 8-14 years of both ages.
- Participants actively engaged in contact sports.
- Children who require mouthguards for protection.
- Cooperative children.
Key exclusion criteria (4 listed)
- 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.
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 mouthguardsParticipants in the first group will receive 3D printed custom-made mouthguards | Device | 3D printed custom-made mouthguards |
| Traditional custom-made mouthguardsParticipants in the active comparator arm will receive traditional custom-made mouthguards as an intervention | Device | Traditional custom-made mouthguards |
Primary outcome
Changes Speech and in Oral Functions
Time frame: 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)
3 secondary outcomes
Knowledge, attitude, and practice (KAP) of children toward mouthguards
Time frame: initial visit (the first month)
Cost Efficiency of both mouthguards
Time frame: one year
Occlusal thickness changes
Time frame: Three months
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 15 May 2025.
- BackgroundVignesh, T. S., Chinni, S. K., Anumula, L., Sannapureddy, S., Kumar, Y. P., & Rohith, V. V. S. (2023). Knowledge, Attitudes, and Practices of Mouth Guards in the Prevention of Orofacial Injuries in Sports Persons-A Cross-sectional Study. Journal of Interdisciplinary Dentistry, 13(2), 84-89.
- Background: PubMed 35612349Tewari N, Kahler B, Srivastav S, Goel S. How far have we come? A historic scoping review of dental traumatology literature. Dent Traumatol. 2022 Oct;38(5):345-355. doi: 10.1111/edt.12760. Epub 2022 May 25.
- 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 32635307Sousa AM, Pinho AC, Messias A, Piedade AP. Present Status in Polymeric Mouthguards. A Future Area for Additive Manufacturing? Polymers (Basel). 2020 Jul 3;12(7):1490. doi: 10.3390/polym12071490.
- 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 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.
- Background: PubMed 36436198Roberts HW. Sports mouthguard overview: Materials, fabrication techniques, existing standards, and future research needs. Dent Traumatol. 2023 Apr;39(2):101-108. doi: 10.1111/edt.12809. Epub 2022 Nov 27.
- Background: PubMed 39174379Ntovas P, Ladia O, Kois JC, Rahiotis C, Revilla-Leon M. Digital workflow for the fabrication of custom-fit additively manufactured sports mouthguards with balanced occlusion using an optical jaw tracking system: A dental technique. J Prosthet Dent. 2025 Nov;134(5):1536-1541. doi: 10.1016/j.prosdent.2024.07.021. Epub 2024 Aug 22.
- Background: PubMed 33806915Mordini L, Lee P, Lazaro R, Biagi R, Giannetti L. Sport and Dental Traumatology: Surgical Solutions and Prevention. Dent J (Basel). 2021 Mar 23;9(3):33. doi: 10.3390/dj9030033.
- 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 28668098Green JI. The Role of Mouthguards in Preventing and Reducing Sports-related Trauma. Prim Dent J. 2017 May 1;6(2):27-34. doi: 10.1308/205016817821281738.
- Background: PubMed 39092246Dias Goncalves VP, Fontes Vieira CM, Colorado Lopera HA. The production and materials of mouthguards: Conventional vs additive manufacturing - A systematic review. Heliyon. 2024 Jul 8;10(14):e34294. doi: 10.1016/j.heliyon.2024.e34294. eCollection 2024 Jul 30.
- Related InfoLink provided by the sponsor.
- 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.
Related trials for Mouthguard Use
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Obstructive Sleep Apnea
Not yet recruiting
Comparative Assessment of Thickness Changes in 3D-Printed vs. Custom-Made Mouth Guards for Children in Contact Sports
Mouthguard Use Orofacial Injuries Prevention 3D Printed Mouthguard Traditional Custom-made Mouthguard Occlusal Thickness Changes
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.
Yasir M Aljadani, Bachelor's degree of dentistry contact
Gihan M 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 mouthguards and Traditional custom-made mouthguards in people with Mouthguard Use and Orofacial Injuries Prevention, 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 4 inclusion and 4 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 15 May 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 Yasir M Aljadani, Bachelor's degree of dentistry (+201118888921, yasir.aljadani@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes Speech and in Oral Functions (time frame: Six 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 NCT06972823, which also lists 18 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 15 May 2025.