Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-01 @ 7:13 AM
Study NCT ID:
NCT07000435
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-02
First Post:
2025-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Assessment of Thickness Changes in 3D-Printed vs. Custom-Made Mouth Guards for Children in Contact Sports
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-24', 'studyFirstSubmitDate': '2025-05-24', 'studyFirstSubmitQcDate': '2025-05-24', 'lastUpdatePostDateStruct': {'date': '2025-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occlusal thickness changes', 'timeFrame': 'Three months', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'Cost Efficiency of both mouth guards', 'timeFrame': 'One year', 'description': '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)'}, {'measure': 'Changes Speech and in Oral Functions', 'timeFrame': 'Six months', 'description': '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.'}, {'measure': 'Knowledge, attitude, and practice (KAP) of children toward mouthguards', 'timeFrame': 'Initial visit', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['3D printed mouthguard traditional custom-made mouthguard occlusal thickness CAD/CAM 3D printer Children Pediatric Dentistry Contact sports thickness changes'], 'conditions': ['Mouthguard Use Orofacial Injuries Prevention 3D Printed Mouthguard Traditional Custom-made Mouthguard Occlusal Thickness Changes']}, 'referencesModule': {'references': [{'pmid': '38363704', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '38459669', 'type': 'BACKGROUND', 'citation': 'Mat 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.'}, {'pmid': '25520762', 'type': 'BACKGROUND', 'citation': 'Singh 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.'}, {'pmid': '25329428', 'type': 'BACKGROUND', 'citation': 'Tanaka 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.'}, {'pmid': '39578680', 'type': 'BACKGROUND', 'citation': 'Avgerinos 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.'}, {'pmid': '19229577', 'type': 'BACKGROUND', 'citation': 'Sadatsafavi 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.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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:\n\nGroup 1: Receives traditional custom-made mouthguards made from alginate impressions.\n\nGroup 2: Receives 3D-printed custom-made mouthguards created using digital intraoral scans and CAD/CAM 3D printing technology.\n\nPrimary 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))\n\nSecondary Outcomes:\n\nKnowledge, attitudes, and practices (KAP) related to mouthguard use, assessed via a structured questionnaire (Vignesh et al., 2023).\n\nCost-efficiency, evaluated using the incremental cost-effectiveness ratio (ICER).\n\nafter 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.\n\nThe trial aims to assess whether 3D-printed mouthguards offer equal or better protection against orofacial injuries compared to traditional mouthguards'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAthletic children who play contact sports Age ranges between 8-14 years. Compliance: participants must agree to use mouth guard consistently Parental consent Physically fit\n\nExclusion Criteria:\n\nAthletic children who play contact sports Age ranges between 8-14 years. Compliance: participants must agree to use mouth guard consistently Parental consent Physically fit'}, 'identificationModule': {'nctId': 'NCT07000435', 'briefTitle': 'Comparative Assessment of Thickness Changes in 3D-Printed vs. Custom-Made Mouth Guards for Children in Contact Sports', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'Thickness of Mouthguards'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3D printed custom-made mouth guards', 'description': 'This arm will include participants receiving 3D printed custom mouth guards', 'interventionNames': ['Device: 3D printed custom-made mouth guards']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional custom-made mouthguards', 'description': 'Participants in the second group will receive traditional custom-made mouth guards', 'interventionNames': ['Device: Traditional custom-made mouth guards']}], 'interventions': [{'name': '3D printed custom-made mouth guards', 'type': 'DEVICE', 'description': 'Participants in the first group will receive 3D printed custom-made mouth guards', 'armGroupLabels': ['3D printed custom-made mouth guards']}, {'name': 'Traditional custom-made mouth guards', 'type': 'DEVICE', 'description': 'Participants in the active comparator arm will receive traditional custom-made mouth guards as an intervention', 'armGroupLabels': ['Traditional custom-made mouthguards']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': "Mahmoud Tawfik Elbably, Bachelor's degree of dentistry", 'role': 'CONTACT', 'email': 'mahmoud.elbably@dentistry.cu.edu.eg', 'phone': '+201065873681'}], 'overallOfficials': [{'name': 'Gihan Mohamed Abuelniel, Doctoral Degree (Professor)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': "Passant Nagi, Master's Degree", 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Master's Candidate, Department of Pediatric Dentistry, Cairo University", 'investigatorFullName': 'Mahmoud Tawfik Mohamed', 'investigatorAffiliation': 'Cairo University'}}}}