Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2026-03-03 @ 2:33 AM
Study NCT ID:
NCT03685318
Status:
COMPLETED
Last Update Posted:
2022-05-27
First Post:
2018-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Shortening the Palatal Extension of the Mouthguard on the Degree of Satisfaction of Water Polo Players
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-24', 'studyFirstSubmitDate': '2018-09-10', 'studyFirstSubmitQcDate': '2018-09-22', 'lastUpdatePostDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Degree of satisfaction with the mouthguard', 'timeFrame': 'Weeks 1-4', 'description': 'Participant satisfaction was assessed by asking the question "How satisfied are you with your mouthguard?" using a 0-10 point scale, considering 0= totally dissatisfied and 10= totally satisfied. Players rated the mouthguard just after each training session or after each match.'}], 'secondaryOutcomes': [{'measure': 'Degree of interference on speech while using the mouthguard', 'timeFrame': 'Weeks 1-4', 'description': 'The degree of interference on speech while using the mouthguard was assessed by asking the question "How much do you think wearing the mouthguard interferes your ability to speech?" using a 0-10 point scale (considering 0= Not at all to 10= very much). Players rated the mouthguard just after each training session or after each match.'}, {'measure': 'Degree of interference on breathing while using the mouthguard', 'timeFrame': 'Weeks 1-4', 'description': 'The degree of interference on breathing while using the mouthguard was assessed by asking the question "How much do you think wearing the mouthguard interferes your ability to breath?" using a 0-10 point scale (considering 0= Not at all to 10= very much). Players rated the mouthguard just after each training session or after each match.'}, {'measure': 'Degree of interference on swallowing while using the mouthguard', 'timeFrame': 'Weeks 1-4', 'description': 'The degree of interference on swallowing while using the mouthguard was assessed by asking the question "How much do you think wearing the mouthguard interferes your ability to swallow?" using a 0-10 point scale (considering 0= Not at all to 10= very much). Players rated the mouthguard just after each training session or after each match.'}, {'measure': 'Degree of discomfort regarding the gag reflex while using the mouthguard', 'timeFrame': 'Weeks 1-4', 'description': 'The degree of discomfort regarding the gag reflex while using the mouthguard was assessed by asking the question "How much do you think wearing the mouthguard causes a gag reflex?" using a 0-10 point scale (considering 0= Not at all to 10= very much). Players rated the mouthguard just after each training session or after each match.'}, {'measure': 'Degree of discomfort because the mouthguard fits too tight', 'timeFrame': 'Weeks 1-4', 'description': 'The degree of discomfort because the mouthguard fits too tight was assessed by asking the question "How much do you think the mouthguard fits too tight?" using a 0-10 point scale (considering 0= Not at all to 10= very much). Players rated the mouthguard just after each training session or after each match.'}, {'measure': 'Degree of discomfort because the mouthguard fits too loose', 'timeFrame': 'Weeks 1-4', 'description': 'The degree of discomfort because the mouthguard fits too loose was assessed by asking the question "How much do you think the mouthguard fits too loose?" using a 0-10 point scale (considering 0= Not at all to 10= very much). Players rated the mouthguard just after each training session or after each match.'}, {'measure': 'Degree of interference on aesthetics while using the mouthguard', 'timeFrame': 'Weeks 1-4', 'description': 'The degree of interference on aesthetics while using the mouthguard was assessed by asking the question "How much do you think wearing the mouthguard interferes on aesthetics?" using a 0-10 point scale (considering 0= Not at all to 10= very much). Players rated the mouthguard just after each training session or after each match.'}, {'measure': 'Degree of interference on athletic performance while using the mouthguard', 'timeFrame': 'Weeks 1-4', 'description': 'The degree of interference on athletic performance while using the mouthguard was assessed by asking the question "How much do you think wearing the mouthguard interferes athletic performance?" using a 0-10 point scale (considering 0= Not at all to 10= very much). Players rated the mouthguard just after each training session or after each match.'}, {'measure': 'Degree of protection with the mouthguard', 'timeFrame': 'Weeks 1-4', 'description': 'The degree of protection perceived by the participant was assessed by asking the question "How much do you feel protected when you are wearing the mouthguard?" using a 0-10 point scale (considering 0= Not at all to 10= very much). Players rated the mouthguard just after each training session or after each match.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mouth Protectors', 'Quality of Life']}, 'referencesModule': {'references': [{'pmid': '30156365', 'type': 'BACKGROUND', 'citation': 'Zamora-Olave C, Willaert E, Montero-Blesa A, Riera-Punet N, Martinez-Gomis J. Risk of orofacial injuries and mouthguard use in water polo players. Dent Traumatol. 2018 Dec;34(6):406-412. doi: 10.1111/edt.12434. Epub 2018 Oct 10.'}, {'pmid': '21358498', 'type': 'BACKGROUND', 'citation': 'Gebauer DP, Williamson RA, Wallman KE, Dawson BT. The effect of mouthguard design on respiratory function in athletes. Clin J Sport Med. 2011 Mar;21(2):95-100. doi: 10.1097/JSM.0b013e31820428b0.'}, {'pmid': '17000712', 'type': 'BACKGROUND', 'citation': 'Maeda Y, Machi H, Tsugawa T. Influences of palatal side design and finishing on the wearability and retention of mouthguards. Br J Sports Med. 2006 Dec;40(12):1006-8. doi: 10.1136/bjsm.2006.030874. Epub 2006 Sep 25.'}, {'pmid': '28965361', 'type': 'BACKGROUND', 'citation': 'Lloyd JD, Nakamura WS, Maeda Y, Takeda T, Leesungbok R, Lazarchik D, Dorney B, Gonda T, Nakajima K, Yasui T, Iwata Y, Suzuki H, Tsukimura N, Churei H, Kwon KR, Choy MMH, Rock JB. Mouthguards and their use in sports: Report of the 1st International Sports Dentistry Workshop, 2016. Dent Traumatol. 2017 Dec;33(6):421-426. doi: 10.1111/edt.12375.'}, {'pmid': '28428580', 'type': 'BACKGROUND', 'citation': 'Parker K, Marlow B, Patel N, Gill DS. A review of mouthguards: effectiveness, types, characteristics and indications for use. Br Dent J. 2017 Apr 21;222(8):629-633. doi: 10.1038/sj.bdj.2017.365.'}, {'pmid': '30481393', 'type': 'RESULT', 'citation': 'Gomez-Gimeno A, Zamora-Olave C, Cordobes-Navarro M, Willaert E, Martinez-Gomis J. Satisfaction with shortening the palatal extension of a mouthguard for water polo players: A randomized crossover study. Dent Traumatol. 2019 Apr;35(2):135-141. doi: 10.1111/edt.12455. Epub 2019 Jan 7.'}]}, 'descriptionModule': {'briefSummary': 'This study assessed the influence of a reduction of the palate extension of a custom-made mouthguard on the degree of satisfaction of elite water polo players. Eighteen water polo players wore a custom-made conventional mouthguard or a reduced palate extension mouthguard during the training sessions and for competing for two weeks. The sequence was randomized to obtain one-half of the participants started the first week wearing the conventional mouthguard, and the other half wearing the shortened mouthguard. The participants rated the degree of discomfort in reference to speech, breathing, swallowing, nauseas/vomiting, pressure/pain, loosening, aesthetics, and athletic performance, in a 10-point scale, considering 0 no discomfort and 10 maximum discomfort. After each session, players also rated the perception of protection and the degree of satisfaction in a 10-point scale, considering 0 no protection/satisfaction and 10 maximum protection/satisfaction.', 'detailedDescription': 'This crossover intervention study aimed to assess the influence of a reduction of the palate extension of a custom-made mouthguard on the degree of satisfaction of elite water polo players. Eighteen water polo players participated in this study. Two different custom-made mouthguards were made, a conventional one and a reduced palate extension mouthguard. They wore them during the training sessions and for competing one type of mouthguard for the first and fourth week and the other type of mouthguard for the second and third week. The sequence was randomized to obtain one-half of the participants started the first week wearing the conventional mouthguard, and the other half wearing the shortened mouthguard. The participants rated the degree of discomfort or inconvenience in reference to speech, breathing, swallowing, nauseas/vomiting, pressure/pain, loosening, aesthetics, and athletic performance, in a 10-point scale, considering 0 no discomfort/inconvenience and 10 maximum discomfort/inconvenience. After each session, players also rated the perception of protection and the degree of satisfaction in a 10-point scale, considering 0 no protection/satisfaction and 10 maximum protection/satisfaction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* water polo players playing in maximum Spanish category for the season 2017-2018\n* Obtaining written informed consent for participating in the project (model consent form)\n\nExclusion Criteria:\n\n* Players with dental caries, with periodontitis or with temporomandibular joint pain'}, 'identificationModule': {'nctId': 'NCT03685318', 'briefTitle': 'Effect of Shortening the Palatal Extension of the Mouthguard on the Degree of Satisfaction of Water Polo Players', 'organization': {'class': 'OTHER', 'fullName': 'University of Barcelona'}, 'officialTitle': 'Effect of Shortening the Palatal Extension of the Mouthguard on the Degree of Satisfaction of Water Polo Players: A Randomized Crossover Study', 'orgStudyIdInfo': {'id': 'HOUB2018/004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional mouthguard', 'description': 'Use of a conventional custom-made mouthguard while playing water polo for two weeks. The conventional mouthguard is designed with the palatal margin at 6 mm from the cervical line.', 'interventionNames': ['Device: Use of conventional mouthguard']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Shortened mouthguard', 'description': 'Use of a shortened custom-made mouthguard while playing water polo for two weeks. The shortened mouthguard is designed with the palatal margin at 2 mm from the cervical line.', 'interventionNames': ['Device: Use of shortened mouthguard']}], 'interventions': [{'name': 'Use of conventional mouthguard', 'type': 'DEVICE', 'description': 'Use of a conventional custom-made mouthguard while playing water polo', 'armGroupLabels': ['Conventional mouthguard']}, {'name': 'Use of shortened mouthguard', 'type': 'DEVICE', 'description': 'Use of a shortened custom-made mouthguard while playing water polo', 'armGroupLabels': ['Shortened mouthguard']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Jordi Martinez-Gomis', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Barcelona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor DDS. PhD', 'investigatorFullName': 'Jordi Martinez-Gomis', 'investigatorAffiliation': 'University of Barcelona'}}}}