Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-02-27 @ 2:20 PM
Study NCT ID:
NCT04091256
Status:
COMPLETED
Last Update Posted:
2019-09-16
First Post:
2019-07-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Tooth Sensitivity With the Use of Biorepair Toothpaste
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Clinical trials with a single arm: Participants will be treated with desensitizing toothpaste containing zinc-carbonate hydroxyapatite nanocrystals (Zn-CHA) for 8 weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-13', 'studyFirstSubmitDate': '2019-07-26', 'studyFirstSubmitQcDate': '2019-09-13', 'lastUpdatePostDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dentine hypersensitivity (DH) evaluation by means of air-blast sensitivity test, using Schiff Sensitivity Scale (SSS) after 4 weeks.', 'timeFrame': '4 Weeks', 'description': 'This will be assessed using Schiff Sensitivity Scale (SSS) score difference from the baseline, that will be determined immediately before product use and then after 4 weeks of daily brushing with the test sensitive toothpaste. Tooth sensitivity score was assessed by air-blast sensitivity, using Schiff Sensitivity Scale (SSS) as follows: 0 = Subject does not respond to air stimulus, 1 = Subject responds to air stimulus but does not request discontinuation of stimulus, 2 = Subject responds to air stimulus and requests discontinuation or moves from stimulus, 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests.'}], 'secondaryOutcomes': [{'measure': 'Dentine hypersensitivity (DH) evaluation by means of air-blast sensitivity test, using Schiff Sensitivity Scale (SSS) after 8 weeks', 'timeFrame': '8 Weeks', 'description': 'This will be assessed using Schiff Sensitivity Scale (SSS) score difference from the baseline, that will be determined immediately before product use and then after 8 weeks of daily brushing with the test sensitive toothpaste. Tooth sensitivity score was assessed by air-blast sensitivity, using Schiff Sensitivity Scale (SSS) as follows: 0 = Subject does not respond to air stimulus, 1 = Subject responds to air stimulus but does not request discontinuation of stimulus, 2 = Subject responds to air stimulus and requests discontinuation or moves from stimulus, 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Biorepair sensitive toothpaste', 'Clinical trial', 'Dentinal Hypersensitivity', 'Schiff Sensitivity Scale', 'Zinc-carbonate hydroxyapatite nanocrystals'], 'conditions': ['Dentinal Hypersensitivity']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical study is to evaluate the effect of desensitizing toothpaste containing zinc-carbonate hydroxyapatite nanocrystals in reducing or controlling DH after 8 weeks of treatment', 'detailedDescription': 'This clinical study design is an 8-week single center, before and after use of desensitize dentifrice. This study will conducted in the College of Dentistry Qassim University. 72 patients surfing from DH, include in the study fulfill the inclusion criteria. All subjects 20 to 70 years of age in good health, and must have 2 teeth with DH, will be included in this study. Screening will be performed for the selection of patients, which fulfill the inclusion criteria. Baseline data will be recorded and Sensitivity was assessed by air-blast sensitivity, using Schiff Sensitivity Scale (SSS).\n\nSensitivity was assessed by air-blast sensitivity, using Schiff Sensitivity Scale (SSS) described as follows.\n\n0 = Subject does not respond to air stimulus\n\n1. = Subject responds to air stimulus but does not request discontinuation of stimulus\n2. = Subject responds to air stimulus and requests discontinuation or moves from stimulus\n3. = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All male and female subjects 20 to 70 years of age\n* All subjects in good health\n* All subjects must have 2 teeth with DH, only incisors, canine and premolars were included with the exposed cervical dentin (facial surfaces).\n\nAll participants of the study having Schiff Sensitivity Scale score of 2 \\& 3\n\nExclusion Criteria:\n\n* Subjects with deep carious teeth, defective restorations\n* Any pathological lesion\n* Periodontal disease, mobile teeth, cracked enamel, orthodontic appliances,\n* Periodontal pockets \\>4mm\n* Subjects using pain control medicines, sensitive toothpaste\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT04091256', 'briefTitle': 'Treatment of Tooth Sensitivity With the Use of Biorepair Toothpaste', 'organization': {'class': 'OTHER', 'fullName': 'Qassim University'}, 'officialTitle': 'Evaluate Efficacy of Desensitizing Toothpaste Containing Zinc-carbonate Hydroxyapatite Before and After: A 8 Week Clinical Study', 'orgStudyIdInfo': {'id': 'ST/55/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clinical trials with a single arm', 'description': ': Participants will be treated with desensitizing toothpaste containing zinc-carbonate hydroxyapatite nanocrystals (Zn-CHA) for 8 weeks.', 'interventionNames': ['Other: Single arm clinical study']}], 'interventions': [{'name': 'Single arm clinical study', 'type': 'OTHER', 'description': 'Participants will be treated with desensitizing toothpaste containing zinc-carbonate hydroxyapatite nanocrystals (Zn-CHA) for 8 weeks.', 'armGroupLabels': ['Clinical trials with a single arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51452', 'city': 'Buraidah', 'state': 'Al Qassim', 'country': 'Saudi Arabia', 'facility': 'College of Dentistry Qassim University', 'geoPoint': {'lat': 26.32599, 'lon': 43.97497}}], 'overallOfficials': [{'name': 'Dhafer Al Asmari, Board', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qassim University'}, {'name': 'Muhammad K Khan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qassim University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qassim University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Muhammad Khalil Khan', 'investigatorAffiliation': 'Qassim University'}}}}