Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT05040620
Status:
UNKNOWN
Last Update Posted:
2021-09-10
First Post:
2020-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Olive Oil Local Application in Orthodontic Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069463', 'term': 'Olive Oil'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-02', 'size': 209613, 'label': 'Study Protocol and Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'Prot_ICF_000.pdf', 'typeAbbrev': 'Prot_ICF', 'uploadDate': '2020-11-15T04:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-03', 'studyFirstSubmitDate': '2020-11-15', 'studyFirstSubmitQcDate': '2021-09-03', 'lastUpdatePostDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The duration of orthodontic teeth aligning using Little irregualrity index', 'timeFrame': '4 months', 'description': "To detect the effect of local usage of Olive Oil on orthodontic brackets during the alignment phase of orthodontic treatment in changing the Little's irregularity in- dex."}], 'secondaryOutcomes': [{'measure': 'orthodontic wire surface roughness changes', 'timeFrame': 'one month', 'description': 'To examine the change in surface roughness of Nickel-Titanium and stainless steel archwires when using Olive Oil as a lubricant and without usage of a lubricant.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Orthodontic tooth movement, olive oil'], 'conditions': ['Orthodontic Tooth Movement']}, 'referencesModule': {'references': [{'pmid': '19413397', 'type': 'RESULT', 'citation': 'Ehsani S, Mandich MA, El-Bialy TH, Flores-Mir C. Frictional resistance in self-ligating orthodontic brackets and conventionally ligated brackets. A systematic review. Angle Orthod. 2009 May;79(3):592-601. doi: 10.2319/060208-288.1.'}, {'pmid': '15898384', 'type': 'RESULT', 'citation': 'Chimenti C, Franchi L, Di Giuseppe MG, Lucci M. Friction of orthodontic elastomeric ligatures with different dimensions. Angle Orthod. 2005 May;75(3):421-5. doi: 10.1043/0003-3219(2005)75[421:FOOELW]2.0.CO;2.'}, {'pmid': '26438988', 'type': 'RESULT', 'citation': 'Carrion-Vilches FJ, Bermudez MD, Fructuoso P. Static and kinetic friction force and surface roughness of different archwire-bracket sliding contacts. Dent Mater J. 2015;34(5):648-53. doi: 10.4012/dmj.2014-295.'}, {'pmid': '18456144', 'type': 'RESULT', 'citation': 'Matarese G, Nucera R, Militi A, Mazza M, Portelli M, Festa F, Cordasco G. Evaluation of frictional forces during dental alignment: an experimental model with 3 nonleveled brackets. Am J Orthod Dentofacial Orthop. 2008 May;133(5):708-15. doi: 10.1016/j.ajodo.2006.06.021.'}, {'pmid': '24160997', 'type': 'RESULT', 'citation': 'Yanase Y, Ioi H, Nishioka M, Takahashi I. Effects of sliding velocity on friction: an in vitro study at extremely low sliding velocity approximating orthodontic tooth movement. Angle Orthod. 2014 May;84(3):451-8. doi: 10.2319/060513-427.1. Epub 2013 Oct 25.'}, {'pmid': '29495598', 'type': 'RESULT', 'citation': 'Gorzynik-Debicka M, Przychodzen P, Cappello F, Kuban-Jankowska A, Marino Gammazza A, Knap N, Wozniak M, Gorska-Ponikowska M. Potential Health Benefits of Olive Oil and Plant Polyphenols. Int J Mol Sci. 2018 Feb 28;19(3):686. doi: 10.3390/ijms19030686.'}, {'pmid': '24778424', 'type': 'RESULT', 'citation': 'Gotsis E, Anagnostis P, Mariolis A, Vlachou A, Katsiki N, Karagiannis A. Health benefits of the Mediterranean Diet: an update of research over the last 5 years. Angiology. 2015 Apr;66(4):304-18. doi: 10.1177/0003319714532169. Epub 2014 Apr 27.'}, {'pmid': '32423007', 'type': 'RESULT', 'citation': 'Curto A, Albaladejo A, Montero J, Alvarado A. Influence of a Lubricating Gel (Orthospeed(R)) on Pain and Oral Health-Related Quality of Life in Orthodontic Patients during Initial Therapy with Conventional and Low-Friction Brackets: A Prospective Randomized Clinical Trial. J Clin Med. 2020 May 14;9(5):1474. doi: 10.3390/jcm9051474.'}, {'pmid': '1059332', 'type': 'RESULT', 'citation': 'Little RM. The irregularity index: a quantitative score of mandibular anterior alignment. Am J Orthod. 1975 Nov;68(5):554-63. doi: 10.1016/0002-9416(75)90086-x.'}]}, 'descriptionModule': {'briefSummary': 'The large body of evidence supports the chemotherapeutic potential of substances found in Olive Oil (OO), acting on different sides, such as inflammation, oxidative damage, and even epigenetic modulation. The consumption of OO should be suggested in a healthy diet instead of other types of oils. It looks worthy, to determine the effect of local application of Olive Oil in decreasing the friction between brackets and wires during orthodontic treatment.', 'detailedDescription': 'During the orthodontic treatment, the friction between the bracket and the arch-wire could prevent the action of forces required for a particular tooth movement. Studies demonstrated that approximately 12 to 60% of the force used to move a tooth is dissipated in the form of friction. Consequently, a delay could occur in the biological response to orthodontic movement. The most important factors that may have an impact on friction are; the composition of the bracket, the arch-wire alloy, the cross-sectional size of the arch-wire, the type of ligation system and the surface roughness of the bracket-archwire assembly.\n\nIn addition to the factors related to the orthodontic appliances, saliva is considered to be a biological variable associated with friction, as it acts as a lubricant during sliding mechanics.This fact should be taken into account in laboratory studies that aim to evaluate the performance of the archwire-bracket combinations. However, in the majority of the research studies, the friction test has been conducted without the use of any lubricant, which does not represent the clinical reality where there is saliva introduced during the movement of the arch-wire on the bracket. To remedy this situation, distilled water has been used as a lubricant. Although in this case the test is conducted in the presence of a lubricant, water does not have the lubricating ability of natural human saliva.\n\nIt is well known that oil is a well-known lubricant. But how we can use it to decrease friction between brackets and wires? and which type of oil we can use safely in patient mouth? Olive oil (OO) (Olea europaea, Oleaceae) is a fundamental component of the Mediterranean Diet; it is a mix of fatty acids such as oleic and linoleic acid, secoiridoids (oleuropein and oleocanthal), simple phenols (tyrosol and hydroxytyrosol), lignans (pinoresinol), flavonoids (apigenin), hydrocarbons (squalene), triterpenes (maslinic acid), and phytosterols (β-sitosterol).\n\nThe large body of evidence supports the chemotherapeutic potential of substances found in OO, acting on different sides, such as inflammation, oxidative damage, and even epigenetic modulation. The consumption of OO should be suggested in a healthy diet instead of other types of oils. It looks worthy, to determine the effect of local application of Olive Oil in decreasing the friction between brackets and wires during orthodontic treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The age of patients ranges from 15-20 years old.\n2. Mild to moderate dental irregularity requiring non-extraction treatment.\n3. Presence of all the permanent teeth at least up to the first molars.\n4. Good oral hygiene, and periodontal health.\n\nExclusion Criteria:\n\n1. Patients require orthognathic surgery to correct skeletal discrepancies.\n2. patients who are taking medications, like NSAIDs or other anti-inflammatory drugs.\n3. cleft lip or palate patients.\n4. patients with hypodontia, or hyperdontia.'}, 'identificationModule': {'nctId': 'NCT05040620', 'briefTitle': 'Effectiveness of Olive Oil Local Application in Orthodontic Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Effectiveness of Olive Oil Local Application in Decreasing the Period of Alignment Phase in Non Extraction Orthodontic Patients. A Randomized Controlled Clinical Trial.', 'orgStudyIdInfo': {'id': '455'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Placebo', 'description': 'controlling group who will receive traditional orthodontic treatment.'}, {'type': 'EXPERIMENTAL', 'label': 'Olive Oil', 'description': 'experimental group who will receive the local application of Olive Oil five times daily after teeth brushing', 'interventionNames': ['Drug: Olive Oil Topical Oil']}], 'interventions': [{'name': 'Olive Oil Topical Oil', 'type': 'DRUG', 'otherNames': ['olive oil'], 'description': 'the effect of olive oil local application in decreasing orthodontic alighment phase', 'armGroupLabels': ['Olive Oil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61111', 'city': 'Minya', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Nasef, lecturer', 'role': 'CONTACT', 'email': 'a.nasef_ortho@hotmail.com', 'phone': '002-01003383457'}, {'name': 'Asmaa Mahmoud, lecturer', 'role': 'CONTACT', 'email': 'dentistasmaa_biology@hotmail.com', 'phone': '002-01002966412'}], 'facility': 'Ahmed Nasef', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'centralContacts': [{'name': 'Ahmed Nasef, lecturer', 'role': 'CONTACT', 'email': 'a.nasef_ortho@hotmail.com', 'phone': '002-01003383457'}, {'name': 'Asmaa Mahmoud, lecturer', 'role': 'CONTACT', 'email': 'dentistasmaa_biology@hotmail.com', 'phone': '002-01002966412'}], 'overallOfficials': [{'name': 'Ahmed Nasef, lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'lecturer of orthodontics, Minia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'planning not to share study methodology until finishing the study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Orthodontics, Faculty of Dentistry, Minia University, Egypt', 'investigatorFullName': 'Ahmed Nasef Abdelhameed', 'investigatorAffiliation': 'Minia University'}}}}