Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
Study NCT ID:
NCT05738356
Status:
COMPLETED
Last Update Posted:
2024-05-02
First Post:
2023-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of White Spot Lesion Development Using 3 Orthodontic Adhesive Systems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The investigator was capturing the images (that were analyzed to measure the outcomes), while a research assistant was saving the images of the patients with coding system'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Three parallel groups'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-01', 'studyFirstSubmitDate': '2023-02-04', 'studyFirstSubmitQcDate': '2023-02-20', 'lastUpdatePostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average lesion fluorescence loss (ΔF%)', 'timeFrame': '4 months', 'description': 'It reflects mineral loss from tooth surface (in percent)'}, {'measure': 'surface area of WSL', 'timeFrame': '4 months', 'description': 'Area of mineral loss measured in pixels'}, {'measure': 'Incidence of WSL', 'timeFrame': '4 months', 'description': 'Number of newly developed WSLs'}], 'secondaryOutcomes': [{'measure': 'Maximum lesion fluorescence loss (ΔFMAX%)', 'timeFrame': '4 months', 'description': 'It reflects the deepest area of the WSL (in percent)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Self-etch primer, one step adhesive'], 'conditions': ['White Spot Lesion']}, 'referencesModule': {'references': [{'pmid': '6758594', 'type': 'BACKGROUND', 'citation': 'Gorelick L, Geiger AM, Gwinnett AJ. Incidence of white spot formation after bonding and banding. Am J Orthod. 1982 Feb;81(2):93-8. doi: 10.1016/0002-9416(82)90032-x.'}, {'pmid': '27476362', 'type': 'BACKGROUND', 'citation': 'Mohammed RE, Abass S, Abubakr NH, Mohammed ZM. Comparing orthodontic bond failures of light-cured composite resin with chemical-cured composite resin: A 12-month clinical trial. Am J Orthod Dentofacial Orthop. 2016 Aug;150(2):290-4. doi: 10.1016/j.ajodo.2016.02.013.'}, {'pmid': '13271655', 'type': 'BACKGROUND', 'citation': 'BUONOCORE MG. A simple method of increasing the adhesion of acrylic filling materials to enamel surfaces. J Dent Res. 1955 Dec;34(6):849-53. doi: 10.1177/00220345550340060801. No abstract available.'}, {'pmid': '8922502', 'type': 'BACKGROUND', 'citation': 'Frazier MC, Southard TE, Doster PM. Prevention of enamel demineralization during orthodontic treatment: an in vitro study using pit and fissure sealants. Am J Orthod Dentofacial Orthop. 1996 Nov;110(5):459-65. doi: 10.1016/s0889-5406(96)70050-1.'}, {'pmid': '27007753', 'type': 'BACKGROUND', 'citation': 'Miller CC, Burnside G, Higham SM, Flannigan NL. Quantitative Light-induced Fluorescence-Digital as an oral hygiene evaluation tool to assess plaque accumulation and enamel demineralization in orthodontics. Angle Orthod. 2016 Nov;86(6):991-997. doi: 10.2319/092415-648.1. Epub 2016 Mar 23.'}, {'pmid': '16448281', 'type': 'BACKGROUND', 'citation': 'Bishara SE, Ajlouni R, Laffoon JF, Warren JJ. Comparison of shear bond strength of two self-etch primer/adhesive systems. Angle Orthod. 2006 Jan;76(1):123-6. doi: 10.1043/0003-3219(2006)076[0123:COSBSO]2.0.CO;2.'}, {'type': 'BACKGROUND', 'citation': "Elkalza, A., Mostafa, D. (2018). 'Laboratory evaluation of shear bond strength of three different bonding systems for orthodontic brackets', Egyptian Orthodontic Journal, 53(June 2018), pp. 55-60. doi: 10.21608/eos.2018.77121"}, {'pmid': '34202013', 'type': 'BACKGROUND', 'citation': 'Choi A, Yoo KH, Yoon SY, Park BS, Kim IR, Kim YI. Anti-Microbial and Remineralizing Properties of Self-Adhesive Orthodontic Resin Containing Mesoporous Bioactive Glass. Materials (Basel). 2021 Jun 25;14(13):3550. doi: 10.3390/ma14133550.'}, {'pmid': '9743128', 'type': 'BACKGROUND', 'citation': 'Bishara SE, Gordan VV, VonWald L, Olson ME. Effect of an acidic primer on shear bond strength of orthodontic brackets. Am J Orthod Dentofacial Orthop. 1998 Sep;114(3):243-7. doi: 10.1016/s0889-5406(98)70205-7.'}, {'pmid': '11395706', 'type': 'BACKGROUND', 'citation': 'Bishara SE, VonWald L, Laffoon JF, Warren JJ. Effect of a self-etch primer/adhesive on the shear bond strength of orthodontic brackets. Am J Orthod Dentofacial Orthop. 2001 Jun;119(6):621-4. doi: 10.1067/mod.2001.113269.'}, {'pmid': '26061985', 'type': 'BACKGROUND', 'citation': 'Montasser MA, El-Wassefy NA, Taha M. In vitro study of the potential protection of sound enamel against demineralization. Prog Orthod. 2015;16:12. doi: 10.1186/s40510-015-0080-2. Epub 2015 May 22.'}, {'pmid': '25391496', 'type': 'BACKGROUND', 'citation': 'Paschos E, Rosenbeck KA, Huth KC, Rudzki I, Wichelhaus A, Kunzelmann KH. Evaluation of the effect of bracket-periphery treatment on prevention of enamel demineralization by consecutive muCT scans. Clin Oral Investig. 2015 Jul;19(6):1519-26. doi: 10.1007/s00784-014-1351-x. Epub 2014 Nov 14.'}, {'pmid': '14158464', 'type': 'BACKGROUND', 'citation': 'SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.'}, {'pmid': '5237684', 'type': 'BACKGROUND', 'citation': 'Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.'}, {'pmid': '32354432', 'type': 'BACKGROUND', 'citation': 'Albhaisi Z, Al-Khateeb SN, Abu Alhaija ES. Enamel demineralization during clear aligner orthodontic treatment compared with fixed appliance therapy, evaluated with quantitative light-induced fluorescence: A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2020 May;157(5):594-601. doi: 10.1016/j.ajodo.2020.01.004.'}, {'pmid': '24952017', 'type': 'BACKGROUND', 'citation': 'Al-Khateeb SN, Tarazi SJ, Al Maaitah EF, Al-Batayneh OB, Abu Alhaija ES. Does acid etching enhance remineralisation of arrested white spot lesions? Eur Arch Paediatr Dent. 2014 Dec;15(6):413-9. doi: 10.1007/s40368-014-0131-2. Epub 2014 Jun 21.'}, {'pmid': '6573846', 'type': 'BACKGROUND', 'citation': 'Houston WJ. The analysis of errors in orthodontic measurements. Am J Orthod. 1983 May;83(5):382-90. doi: 10.1016/0002-9416(83)90322-6.'}, {'pmid': '3466795', 'type': 'BACKGROUND', 'citation': 'Artun J, Brobakken BO. Prevalence of carious white spots after orthodontic treatment with multibonded appliances. Eur J Orthod. 1986 Nov;8(4):229-34. doi: 10.1093/ejo/8.4.229. No abstract available.'}, {'pmid': '23289733', 'type': 'BACKGROUND', 'citation': 'Julien KC, Buschang PH, Campbell PM. Prevalence of white spot lesion formation during orthodontic treatment. Angle Orthod. 2013 Jul;83(4):641-7. doi: 10.2319/071712-584.1. Epub 2013 Jan 4.'}, {'pmid': '26241805', 'type': 'BACKGROUND', 'citation': 'Brown MD, Campbell PM, Schneiderman ED, Buschang PH. A practice-based evaluation of the prevalence and predisposing etiology of white spot lesions. Angle Orthod. 2016 Mar;86(2):181-6. doi: 10.2319/041515-249.1. Epub 2015 Aug 4.'}, {'pmid': '19409343', 'type': 'BACKGROUND', 'citation': 'Paschos E, Kleinschrodt T, Clementino-Luedemann T, Huth KC, Hickel R, Kunzelmann KH, Rudzki-Janson I. Effect of different bonding agents on prevention of enamel demineralization around orthodontic brackets. Am J Orthod Dentofacial Orthop. 2009 May;135(5):603-12. doi: 10.1016/j.ajodo.2007.11.028.'}, {'pmid': '25158949', 'type': 'BACKGROUND', 'citation': 'Visel D, Jacker T, Jost-Brinkmann PG, Prager TM. Demineralization adjacent to orthodontic brackets after application of conventional and self-etching primer systems. J Orofac Orthop. 2014 Sep;75(5):358-73. doi: 10.1007/s00056-014-0233-9. Epub 2014 Aug 28.'}, {'pmid': '31545075', 'type': 'BACKGROUND', 'citation': 'Rasmussen MJ, Togrye C, Trojan TM, Tantbirojn D, Versluis A. Post-gel shrinkage, elastic modulus, and stress generated by orthodontic adhesives. Angle Orthod. 2020 Mar;90(2):278-284. doi: 10.2319/032719-233.1. Epub 2019 Sep 23.'}, {'pmid': '3164585', 'type': 'BACKGROUND', 'citation': 'Ogaard B, Rolla G, Arends J. Orthodontic appliances and enamel demineralization. Part 1. Lesion development. Am J Orthod Dentofacial Orthop. 1988 Jul;94(1):68-73. doi: 10.1016/0889-5406(88)90453-2.'}, {'pmid': '15591733', 'type': 'BACKGROUND', 'citation': 'Boersma JG, van der Veen MH, Lagerweij MD, Bokhout B, Prahl-Andersen B. Caries prevalence measured with QLF after treatment with fixed orthodontic appliances: influencing factors. Caries Res. 2005 Jan-Feb;39(1):41-7. doi: 10.1159/000081655.'}, {'pmid': '21208070', 'type': 'BACKGROUND', 'citation': 'Tufekci E, Dixon JS, Gunsolley JC, Lindauer SJ. Prevalence of white spot lesions during orthodontic treatment with fixed appliances. Angle Orthod. 2011 Mar;81(2):206-10. doi: 10.2319/051710-262.1.'}, {'pmid': '19201328', 'type': 'BACKGROUND', 'citation': 'Ghiz MA, Ngan P, Kao E, Martin C, Gunel E. Effects of sealant and self-etching primer on enamel decalcification. Part II: an in-vivo study. Am J Orthod Dentofacial Orthop. 2009 Feb;135(2):206-13. doi: 10.1016/j.ajodo.2007.02.060.'}, {'pmid': '2816842', 'type': 'BACKGROUND', 'citation': 'Ogaard B. Prevalence of white spot lesions in 19-year-olds: a study on untreated and orthodontically treated persons 5 years after treatment. Am J Orthod Dentofacial Orthop. 1989 Nov;96(5):423-7. doi: 10.1016/0889-5406(89)90327-2.'}, {'pmid': '1298574', 'type': 'BACKGROUND', 'citation': 'Donly KJ, Ruiz M. In vitro demineralization inhibition of enamel caries utilizing an unfilled resin. Clin Prev Dent. 1992 Nov-Dec;14(6):22-4.'}, {'pmid': '16448283', 'type': 'BACKGROUND', 'citation': 'Cal-Neto JP, Miguel JA. Scanning electron microscopy evaluation of the bonding mechanism of a self-etching primer on enamel. Angle Orthod. 2006 Jan;76(1):132-6. doi: 10.1043/0003-3219(2006)076[0132:SEMEOT]2.0.CO;2.'}], 'seeAlsoLinks': [{'url': 'http://www.random.org/sequences/.', 'label': 'Randomization App'}]}, 'descriptionModule': {'briefSummary': 'The gaol of this randomized clinical trial was to compare the effect of self-etching primer bonding system and one step adhesive bonding system on the development of white spot lesions (WSLs) during fixed orthodontic therapy in comparison with the conventional 3 step bonding system.\n\nAll participants will be bonded with similar fixed orthodontic appliances using each type of adhesives for the assigned group. WSLs will be monitored during the orthodontic treatment', 'detailedDescription': 'Objectives: The objective of this clinical trial was to compare the effect of self-etching primer bonding system and one step adhesive bonding system on the development of WSLs during fixed orthodontic therapy in comparison with the conventional 3 step bonding system.\n\nMaterials and Methods: Seventy five patients were randomly allocated into 3 groups (Group 1, conventional bonding system, n=25; Group 2, self-etch primer n=25; Group 3, primer mixed with the adhesive composite n=25). Quantitative light-induced fluorescence (QLF) was used to quantify WSL parameters. Images were captured and then analyzed before treatment; 2 months and 4 months after bond-up. Lesion area (Pixels), mean fluorescence loss (∆F) and the number of newly developed WSLs were compared within and between the 3 groups. The significance level was set at P ≤ 0.05.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '17 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy patients from both sexes aged 17 - 25 years\n* Mild-to-moderate crowding (≤5 mm)\n* Optimum oral hygiene\n* Maximum of 3 restored teeth\n* Absence of defective enamel formation in the form of hypocalcification or hypoplasia\n* No salivary gland diseases.\n\nExclusion Criteria:\n\n* Patients with poor oral hygiene\n* Heavily restored teeth\n* Sever crowding\n* Presence of systemic disease that may affect salivary glands or the ability to brush their teeth properly.'}, 'identificationModule': {'nctId': 'NCT05738356', 'briefTitle': 'Evaluation of White Spot Lesion Development Using 3 Orthodontic Adhesive Systems', 'organization': {'class': 'OTHER', 'fullName': 'Jordan University of Science and Technology'}, 'officialTitle': 'Comparison of Three Orthodontic Bonding Systems in White Spot Lesion Development: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'JUST20220118'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Three-step adhesive', 'description': 'The orthodontic appliances were bonded to the patients teeth using conventional 3 step adhesive (3M™ Transbond™ XT, 3M Unitek, United States)', 'interventionNames': ['Combination Product: Adhesive bonding systems']}, {'type': 'EXPERIMENTAL', 'label': 'Self-etch primer adhesive', 'description': 'The orthodontic appliances were bonded to the patients teeth using self-etch primer (3M™ Transbond™ Plus, 3M Unitek, United States).', 'interventionNames': ['Combination Product: Adhesive bonding systems']}, {'type': 'EXPERIMENTAL', 'label': 'One-step adhesive system', 'description': 'The orthodontic appliances were bonded to the patients teeth using one-step adhesive system (GC Ortho Connect™, GC Orthodontics, Germany)', 'interventionNames': ['Combination Product: Adhesive bonding systems']}], 'interventions': [{'name': 'Adhesive bonding systems', 'type': 'COMBINATION_PRODUCT', 'description': 'Three different adhesive bonding systems were used; one system per group', 'armGroupLabels': ['One-step adhesive system', 'Self-etch primer adhesive', 'Three-step adhesive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22110', 'city': 'Irbid', 'country': 'Jordan', 'facility': 'Postgraduate Dental Teaching Clinics/JUST', 'geoPoint': {'lat': 32.55556, 'lon': 35.85}}], 'overallOfficials': [{'name': 'Susan Al-Khateeb, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Dentistry/Jordan University of Science and Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be available upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jordan University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}