Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-04-05 @ 12:37 PM
Study NCT ID:
NCT03656432
Status:
UNKNOWN
Last Update Posted:
2018-09-06
First Post:
2018-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of CPP-ACP With/Without Fl on White Spot Lesion,Salivary pH and fl Release in High Caries Risk Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-04', 'studyFirstSubmitDate': '2018-08-30', 'studyFirstSubmitQcDate': '2018-08-30', 'lastUpdatePostDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'White Spot Lesion (WSL) progression', 'timeFrame': '(T1) baseline before application, (T2) immediate after application, (T3) 1 day, (T4) 1 week and (T5) 1 month.', 'description': 'The researcher will inspect the development of any new WSLs in the oral cavity in the clinic of Conservative Dentistry Department Cairo University. The software quantifies the green and red fluorescent light on a scale from 0 to 3 as a ratio of red to green, showing the areas with a higher than healthy tooth ratio.'}], 'secondaryOutcomes': [{'measure': 'unstimulated Salivary pH change', 'timeFrame': '(T1) baseline before application, (T2) immediate after application, (T3) 1 day, (T4) 1 week and (T5) 1 month.', 'description': 'The researcher will collect unstimulated saliva pH samples from outpatient clinic at Conservative Dentistry Department Cairo University which will be measured immediately using digital pH meter. It has no measuring unit, but it only displays numerical value.'}, {'measure': 'stimulated Fluoride Release', 'timeFrame': 'For the WSLs assessment, (T1) baseline before application, (T2) 1 month and (T3) 3 months', 'description': 'The researcher will collect stimulated salivary sample from the participant for fluoride release measurement by selective ion electrode in ppm(mg/l).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CPP-ACP pastes', 'CPP_ACPF', 'Fluoride release', 'early carious lesion'], 'conditions': ['Caries']}, 'referencesModule': {'references': [{'pmid': '28959766', 'type': 'BACKGROUND', 'citation': 'Poureslami H, Hoseinifar R, Khazaeli P, Hoseinifar R, Sharifi H, Poureslami P. Changes in the Concentration of Ions in Saliva and Dental Plaque after Application of CPP-ACP with and without Fluoride among 6-9 Year Old Children. J Dent Biomater. 2017 Mar;4(1):361-366.'}, {'pmid': '29211281', 'type': 'BACKGROUND', 'citation': 'Sinfiteli PP, Coutinho TCL, Oliveira PRA, Vasques WF, Azevedo LM, Pereira AMB, Tostes MA. Effect of fluoride dentifrice and casein phosphopeptide-amorphous calcium phosphate cream with and without fluoride in preventing enamel demineralization in a pH cyclic study. J Appl Oral Sci. 2017 Nov-Dec;25(6):604-611. doi: 10.1590/1678-7757-2016-0559.'}, {'pmid': '24856191', 'type': 'BACKGROUND', 'citation': 'Heshmat H, Banava S, Mohammadi E, Kharazifard MJ, Mojtahedzadeh F. The effect of recommending a CPP-ACPF product on salivary and plaque pH levels in orthodontic patients: a randomized cross-over clinical trial. Acta Odontol Scand. 2014 Nov;72(8):903-7. doi: 10.3109/00016357.2014.920515. Epub 2014 May 26.'}, {'pmid': '28512540', 'type': 'BACKGROUND', 'citation': 'Ebrahimi M, Mehrabkhani M, Ahrari F, Parisay I, Jahantigh M. The effects of three remineralizing agents on regression of white spot lesions in children: A two-week, single-blind, randomized clinical trial. J Clin Exp Dent. 2017 May 1;9(5):e641-e648. doi: 10.4317/jced.53582. eCollection 2017 May.'}, {'pmid': '23721337', 'type': 'BACKGROUND', 'citation': 'Tassery H, Levallois B, Terrer E, Manton DJ, Otsuki M, Koubi S, Gugnani N, Panayotov I, Jacquot B, Cuisinier F, Rechmann P. Use of new minimum intervention dentistry technologies in caries management. Aust Dent J. 2013 Jun;58 Suppl 1:40-59. doi: 10.1111/adj.12049.'}], 'seeAlsoLinks': [{'url': 'http://www.gcamerica.com/products/preventive/MI_Paste/index.php', 'label': 'Topical Tooth Créme Containing Calcium, Phosphate \\& Fluoride'}]}, 'descriptionModule': {'briefSummary': 'Effect of CPP-ACP pastes with/without Fluoride on White spot lesion progression, salivary pH and fluoride release in high caries risk Patients, over 3 month period using VistaCam, Digital pH meter and Selective ion electrode.', 'detailedDescription': 'Dental caries is the most prevalent disease affecting the Human beings, it is a complex disease affecting teeth, which is caused by imbalance between demineralization and remineralization process in the oral cavity.\n\nPreventive measures will stop the development of early caries lesions or even will direct the progression of this early carious lesions towards remineralization.\n\nNowadays, researchers have focused on non-invasive techniques to prevent early caries lesions appearance. In recent years, a calcium and phosphate remineralization technology has been introduced to decrease their incidence that relies on Casein Phospho-Peptide-Amorphous Calcium Phosphate (CPP-ACP).\n\nThe complex CPP-ACP derived from a milk protein called casein. CPP-ACP represents an alternative remineralizing agent that prevents the early demineralization, it is capable of stabilizing calcium phosphate, maintaining the supersaturation of these ions in the oral environment by binding with them and transport them in the form of amorphous calcium phosphate. They can enhance remineralization, decrease demineralization or even both in an acid challenge to teeth surfaces.\n\nCPP-ACP with sodium fluoride 0.2% (900 ppm) that is very similar to the amount of fluoride in the toothpaste binds to the tooth surfaces and plaque and provides biocompatible calcium, phosphate and fluoride in a localized way. So, it provides all the ions needed to build fluorapatite crystals that are more resistant to the acid attack compared to hydroxyapatite . It also has a preventive role in the pH control as it might be able to improve pH levels in different areas in the oral cavity.\n\nEarly enamel demineralization is frequently observed as white spot lesions (WSLs) which are opaque enamel areas created by mineral loss from the subsurface layer of enamel. These areas are also defined as incipient or enamel caries. WSLs are the precursors for caries cavities and their milky color may cause esthetic problems .\n\nTaking into consideration that caries detection by eyesight is better for cavitated lesions than for non-cavitated early lesions. Moreover, the visual examination is a subjective method and so it has a lower reproducibility in detecting occlusal caries. Also, radiographic examination has shown high specificity and poor sensitivity for non-cavitated lesions, underestimating the lesion depth . Therefore, the detection of these early carious lesions (WSL) in the initial stage with optimum efficiency achieved by a variety of technologies one of them is the use of autofluorescence technique (VistaCam) for the early detection and diagnosis of these 8 incipient lesions . Studies have shown that white spot lesions can take only one month to develop .\n\nThe VistaCam is an intraoral fluorescence camera that illuminates teeth with a violet light (405 nm) and captures the reflected light as a digital image. Which is then is filtered contains the green yellow fluorescence of normal teeth with a peak at 510 nm, as well as the red fluorescence of bacterial metabolites with a peak at 680 nm. The software quantifies the green and red fluorescent light on a scale from 0 to 3 as a ratio of red to green, showing the areas with a higher than healthy tooth ratio .\n\nAlthough promising, investigations dealing with the effect of CPP-ACP products on plaque and salivary pH levels and in the high caries risk patient appear to be limited and have not been conducted in the form of randomized clinical trials.\n\nTherefore, the purpose of this study was to evaluate the effects of recommending a CPP-ACPF product on salivary pH levels and measuring the amount of fluoride remains in the saliva after using it in high caries risk patients, and also monitoring the prevention of new white spot lesions during the use of CPP\\_ACP with and without fluoride by using the vistaCam as a randomized clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '17 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age range from 17-30 years\n* Males or females\n* High caries risk patients defined according to American Dental Association (ADA)\n* Systematically healthy\n* Not taking any medication interfering with saliva secretion\n* Co-operative patients approving to participate in the trial\n* signed informed consent\n\nExclusion Criteria:\n\n* Patients younger than 17 years old or older than 30 years old.\n* Disabilities\n* Subjects suffering from any medical or systematic disease\n* Smokers\n* Pregnant females\n* Allergy to milk derivatives.\n* using any other agents containing fluoride\n* presence of untreated caries lesions.'}, 'identificationModule': {'nctId': 'NCT03656432', 'briefTitle': 'Effect of CPP-ACP With/Without Fl on White Spot Lesion,Salivary pH and fl Release in High Caries Risk Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of CPP-ACP Pastes With/Without Fluoride on White Spot Lesion Progression, Salivary pH and Fluoride Release in High Caries Risk Patients A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'CEBD-CU-2018-08-29'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CPP-ACP paste', 'description': 'MI Paste represents an alternative remineralizing agent that prevents the early demineralization, it is capable of stabilizing calcium phosphate, maintaining the supersaturation of these ions in the oral environment by binding with them and transport them in the form of amorphous calcium phosphate. They can enhance remineralization, decrease demineralization or even both in an acid challenge to teeth surfaces.', 'interventionNames': ['Drug: CPP-ACP paste']}, {'type': 'EXPERIMENTAL', 'label': 'CPP-ACP containing fluoride', 'description': 'MI paste plus contains fluoride 0.2% (900 ppm) that is very similar to the amount of fluoride in the toothpaste binds to the tooth surfaces and plaque and provides biocompatible calcium, phosphate and fluoride in a localized way. So, it provides all the ions needed to build fluorapatite crystals that are more resistant to the acid attack compared to hydroxyapatite', 'interventionNames': ['Drug: CPP-ACP paste']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'toothpaste contains fluoride', 'description': 'Fluoridated Toothpaste are the most significant and worldwide spread forms of caries control used globally as the greater acceptability of toothpaste makes its regular use more likely, thereby improving effectiveness', 'interventionNames': ['Drug: CPP-ACP paste']}], 'interventions': [{'name': 'CPP-ACP paste', 'type': 'DRUG', 'otherNames': ['CPP-ACP containing fluoride paste'], 'description': 'The complex CPP-ACP derived from a milk protein called casein. CPP-ACP represents an alternative remineralizing agent that prevents the early demineralization, it is capable of stabilizing calcium phosphate, maintaining the supersaturation of these ions in the oral environment by binding with them and transport them in the form of amorphous calcium phosphate. They can enhance remineralization, decrease demineralization or even both in an acid challenge to teeth surfaces.', 'armGroupLabels': ['CPP-ACP containing fluoride', 'CPP-ACP paste', 'toothpaste contains fluoride']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Doaa G Ashour, Master', 'role': 'CONTACT', 'email': 'Doaa.Gamal@dentistry.cu.edu.eg', 'phone': '01006512932', 'phoneExt': '+20'}, {'name': 'Rania S Mosallam, PhD', 'role': 'CONTACT', 'email': 'rania.mosallam@hoymail.com', 'phone': '01004222674', 'phoneExt': '+20'}], 'overallOfficials': [{'name': 'Mohamed R Farid, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor of Conservative Dentistry, Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator and PHD student at Conservative Dentistry Department', 'investigatorFullName': 'Doaa Gamal', 'investigatorAffiliation': 'Cairo University'}}}}