Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT03515902
Status:
COMPLETED
Last Update Posted:
2019-08-06
First Post:
2018-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Mouthguard and Desensitizing Toothpaste in Reducing Dental Hypersensitivity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003807', 'term': 'Dentin Sensitivity'}, {'id': 'D014077', 'term': 'Tooth Erosion'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D057085', 'term': 'Tooth Wear'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009064', 'term': 'Mouth Protectors'}], 'ancestors': [{'id': 'D011313', 'term': 'Preventive Dentistry'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D011482', 'term': 'Protective Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D000067393', 'term': 'Personal Protective Equipment'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-05', 'studyFirstSubmitDate': '2018-04-23', 'studyFirstSubmitQcDate': '2018-04-23', 'lastUpdatePostDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The quality of life after using mouthguard with/without desensitizing toothpaste', 'timeFrame': '8 weeks', 'description': '* The quality of life will be collected by interview at 8 weeks using oral impacts on daily performance (OIDP) questionnaire\n* The score range from 0 (no negative effect on quality of life) to 100 (worst negative effect on quality of life )\n* The mean score will be analyzed.'}], 'primaryOutcomes': [{'measure': 'Tooth hypersensitivity changes after using mouthguard with/without desensitizing toothpaste', 'timeFrame': 'baseline,2,4 and 8 weeks', 'description': '* Tooth hypersensitivity changes will be measured by the mean difference of visual analog scale (VAS) score at baseline,2,4 and 8 weeks by using 2 clinical stimuli including tactile and cold stimulation. Each stimulation will be measured and separately recorded as follow :\n\n 1.Tactile stimulation\n* The score range from 0 (no tooth hypersensitivity) to 100 (worst possibly tooth hypersensitivity)\n* The mean difference of tooth hypersensitivity from tactile stimulation at any time point will be analyzed.\n\n 2\\. Cold stimulation\n* The score range from 0 (no tooth hypersensitivity) to 100 (worst possibly tooth hypersensitivity)\n* The mean difference of tooth hypersensitivity from cold stimulation at any time point will be analyzed.'}], 'secondaryOutcomes': [{'measure': 'The attitude and satisfaction of using mouthguard with/without desensitizing toothpaste', 'timeFrame': '2,4 and 8 weeks', 'description': '* The attitude and satisfaction will be collected by a self-administered questionnaire and interview at 2,4 and 8 weeks\n* The score range from 0 (no satisfying) to 100 (most satisfying)\n* The mean score of satisfying at any time point will be analyzed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dentine Hypersensitivity', 'Toothpaste', 'Tooth erosion'], 'conditions': ['Dentine Hypersensitivity', 'Tooth Erosion']}, 'descriptionModule': {'briefSummary': 'Tooth hypersensitivity due to dental erosion is one of the most common problem related to swimming in improper pH chlorinated pools. Because the teeth are exposed to acidic water for a long time, which cause the loss of dental hard tissue. Tooth hypersensitivity can lead to a negative effect on daily life such as dietary selection, maintaining optimal dental hygiene and beauty aspects. It has been found that using mouthguard while swimming can prevent the teeth directly contact to chlorinated water, so it can protect tooth structure and decrease tooth hypersensitivity. Moreover, using mouthguard with viscous products can seal the gaps between mouthguard and teeth which can help to protect tooth structure and decrease dental hypersensitivity more effectively. At present, there are many desensitizing products such as toothpaste, mouthwash and chewing gum. Desensitizing toothpaste is the most common over-the-counter (OTC) materials in desensitizing. Many research has endorsed the properties of desensitizing toothpaste that can reduce tooth tissue loss and helps to reduce tooth hypersensitivity effectively. So it can be hypothesize that when use the combination of mouthguard with desensitizing toothpaste, it might have synergistic effect on reducing tooth hypersensitivity in swimmers.', 'detailedDescription': 'Tooth erosion is the loss of dental hard tissue due to acidic agents without bacteria involvement.\n\nMouthguard is a protective appliance use for covering the teeth and gums to prevent the teeth from acidic chlorinated water.\n\nDesensitizing toothpaste is toothpaste containing 8 percent arginine and calcium carbonate that can reduce tooth demineralization and promote remineralization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 13-25 years (age under 18 years must obtain consent from parents)\n* Swimming at least 5 hours/week\n* Having tooth hypersensitivity from erosion\n* Can read or understand Thai language\n\nExclusion Criteria:\n\n* History of allergic to toothpaste\n* Having any tooth which will affect to the tightness of mouthguard\n* Having fixed orthodontic appliance'}, 'identificationModule': {'nctId': 'NCT03515902', 'briefTitle': 'The Effects of Mouthguard and Desensitizing Toothpaste in Reducing Dental Hypersensitivity', 'organization': {'class': 'OTHER', 'fullName': 'Khon Kaen University'}, 'officialTitle': 'The Effects of Mouthguard With Desensitizing Toothpaste in Reducing Dental Hypersensitivity in Swimmers : A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'KKUHE612062'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mouthguard', 'description': 'Mouthguard arm is application of mouthguard while swimming', 'interventionNames': ['Device: mouthguard']}, {'type': 'EXPERIMENTAL', 'label': 'mouthguard with desensitizing toothpaste', 'description': 'Mouthguard with desensitizing toothpaste arm is application of mouthguard with desensitizing toothpaste containing 8% arginine and calcium carbonate while swimming', 'interventionNames': ['Device: mouthguard with desensitizing toothpaste']}], 'interventions': [{'name': 'mouthguard', 'type': 'DEVICE', 'description': 'mouthguard', 'armGroupLabels': ['mouthguard']}, {'name': 'mouthguard with desensitizing toothpaste', 'type': 'DEVICE', 'description': 'mouthguard with desensitizing toothpaste containing 8% arginine with calcium carbonate', 'armGroupLabels': ['mouthguard with desensitizing toothpaste']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40002', 'city': 'Khon Kaen', 'country': 'Thailand', 'facility': 'Faculty of Dentistry , Khon Kaen University', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}], 'overallOfficials': [{'name': 'Kemporn Kitsahawong, DDS,MSc,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Dentistry, Khon Kaen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Khon Kaen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Kemporn Kitsahawong', 'investigatorAffiliation': 'Khon Kaen University'}}}}