Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-25 @ 7:22 PM
Study NCT ID:
NCT05962632
Status:
UNKNOWN
Last Update Posted:
2023-07-27
First Post:
2023-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Cost-effectiveness of Different Caries Preventive Protocols
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'assessors will unaware of the treatment assigned to the patients therefore the assessors will not be included in the pre clinical assessment.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-25', 'studyFirstSubmitDate': '2023-07-07', 'studyFirstSubmitQcDate': '2023-07-25', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Caries increment', 'timeFrame': '12 moths', 'description': 'number of carious tooth surfaces will be calculated ( DMFS score)will be monitored and recorded separately.'}], 'secondaryOutcomes': [{'measure': 'Cost-Effectiveness', 'timeFrame': '12 months', 'description': 'the cost effective will be calculated by the statistician (Net costs/Change in health outcome).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prevention'], 'conditions': ['Caries Prevention']}, 'referencesModule': {'references': [{'pmid': '28682498', 'type': 'BACKGROUND', 'citation': 'Schwendicke F, Splieth CH, Thomson WM, Reda S, Stolpe M, Foster Page L. Cost-effectiveness of caries-preventive fluoride varnish applications in clinic settings among patients of low, moderate and high risk. Community Dent Oral Epidemiol. 2018 Feb;46(1):8-16. doi: 10.1111/cdoe.12320. Epub 2017 Jul 6.'}, {'pmid': '30632864', 'type': 'BACKGROUND', 'citation': "El Tantawi M, Bakhurji E, Al-Ansari A, AlSubaie A, Al Subaie HA, AlAli A. Indicators of adolescents' preference to receive oral health information using social media. Acta Odontol Scand. 2019 Apr;77(3):213-218. doi: 10.1080/00016357.2018.1536803. Epub 2019 Jan 11."}, {'pmid': '30517071', 'type': 'BACKGROUND', 'citation': 'Achilleos E, Rahiotis C, Kavvadia K, Vougiouklakis G. Clinical Evaluation of Two Different Prevention Programs in Adults Depending on Their Caries Risk Profile: One-year Results. Oper Dent. 2019 Mar/Apr;44(2):127-137. doi: 10.2341/17-164-C. Epub 2018 Dec 5.'}, {'pmid': '34024883', 'type': 'BACKGROUND', 'citation': 'Shinkai K, Yoshii D. Effect of the S-PRG filler content in the multi-ion releasing paste on the acid resistance of the enamel surface after polishing with the paste. Dent Mater J. 2021 Sep 30;40(5):1136-1141. doi: 10.4012/dmj.2020-303. Epub 2021 May 21.'}, {'pmid': '37103326', 'type': 'BACKGROUND', 'citation': 'Imazato S, Nakatsuka T, Kitagawa H, Sasaki JI, Yamaguchi S, Ito S, Takeuchi H, Nomura R, Nakano K. Multiple-Ion Releasing Bioactive Surface Pre-Reacted Glass-Ionomer (S-PRG) Filler: Innovative Technology for Dental Treatment and Care. J Funct Biomater. 2023 Apr 21;14(4):236. doi: 10.3390/jfb14040236.'}, {'pmid': '31349691', 'type': 'BACKGROUND', 'citation': "Fraihat N, Madae'en S, Bencze Z, Herczeg A, Varga O. Clinical Effectiveness and Cost-Effectiveness of Oral-Health Promotion in Dental Caries Prevention among Children: Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2019 Jul 25;16(15):2668. doi: 10.3390/ijerph16152668."}]}, 'descriptionModule': {'briefSummary': 'To compare the caries preventive efficacy of clinical-based, home based or E-based oral health interventions and their cost effectiveness.', 'detailedDescription': 'Caries risk assessment and preventive measures have been performed over years with different perspectives without attention to budgeting and economic value and the preventive protocols remain uncertain for adults.\n\ncaries prevention, for example using fluoride varnish, has been found only limitedly cost-effective in clinic settings, which is why alternative strategies involving home-based interventions are sought .Electronic health (E-health) interventions for patient motivation and enhancing of patient adherence, for example via reminders about the reinforcement of hygiene measures and dietary counseling as well as recall visits were found to be of value This randomized controlled clinical study aims to compare the caries preventive efficacy of clinical-based, home based or E-based oral health interventions and their cost effectiveness'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* High caries risk patients.\n* 18-25years.\n* Males or females.\n* Participants approving to enrol in this study.\n* Participants not enrolled in any other study.\n\nExclusion Criteria:\n\nlow or moderate caries risk\n\n* Participants with systematic conditions.\n* Patients younger than 18 years.\n* Evidence of parafunctional habits.\n* with developmental dental anomalies.\n* undergoing or will start orthodontic treatment.\n* with removable prosthesis'}, 'identificationModule': {'nctId': 'NCT05962632', 'briefTitle': 'Efficacy and Cost-effectiveness of Different Caries Preventive Protocols', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Efficacy and Cost-effectiveness of Different Caries Preventive Protocols in a High -Risk Group of Young Egyptian Adults: A Randomized Control Trial', 'orgStudyIdInfo': {'id': 'E&C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clinical-based preventive platform', 'description': 'applying of Fluoride varnish every 3 months', 'interventionNames': ['Drug: Fluoride based varnish (Dentkist Charm Fill Varnish )']}, {'type': 'EXPERIMENTAL', 'label': 'Home-based preventive platform', 'description': 'topical remineralizing agent', 'interventionNames': ['Drug: pro care gel remineralizing agent']}, {'type': 'EXPERIMENTAL', 'label': 'E health platform', 'description': 'Mobile application', 'interventionNames': ['Device: Mobile application']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Basic preventive measures', 'description': 'tooth brushing/fluoridated toothpaste over the counter 1450 ppm, interdental cleaning, fluoride rinse OTC', 'interventionNames': ['Combination Product: tooth brushing/fluoridated toothpaste over the counter 1450 ppm, interdental cleaning,fluoride rinse OTC']}], 'interventions': [{'name': 'Fluoride based varnish (Dentkist Charm Fill Varnish )', 'type': 'DRUG', 'description': 'topical Fluoride varnish administrated professionally every 3 months in the clinic', 'armGroupLabels': ['Clinical-based preventive platform']}, {'name': 'pro care gel remineralizing agent', 'type': 'DRUG', 'description': 'topical remineralizing agent (Surface Pre-Reacted Glass ionomer filler SPRG based)SHOFU company', 'armGroupLabels': ['Home-based preventive platform']}, {'name': 'Mobile application', 'type': 'DEVICE', 'description': 'examine the impact of Mobile application on caries prevention', 'armGroupLabels': ['E health platform']}, {'name': 'tooth brushing/fluoridated toothpaste over the counter 1450 ppm, interdental cleaning,fluoride rinse OTC', 'type': 'COMBINATION_PRODUCT', 'description': 'interdental cleaning(dental floss),fluoride rinse OTC (B-FRESH MOUTH WASH )', 'armGroupLabels': ['Basic preventive measures']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'roya mohamed hamad, master', 'role': 'CONTACT', 'email': 'roya.hamad@dentistry.cu.edu.eg', 'phone': '01030435140'}, {'name': 'roya mohamed hamad, master', 'role': 'CONTACT', 'email': 'rowamohamed2014@gmail.com', 'phone': '01030435140'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roya mohamed Hamad Elmaghrbi', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shofu Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'Roya mohamed Hamad Elmaghrbi', 'investigatorAffiliation': 'Cairo University'}}}}