drugset / Trial / NCT05738356
Evaluation of White Spot Lesion Development Using 3 Orthodontic Adhesive Systems
RandomizedParallel-groupTriple-blindDiagnostic
Summary
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. All 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
Timeline
- Start
- 2021-12-10
- Primary completion
- 2022-06-16
- Completion
- 2023-07-01
Publications
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- Background 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.
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- Background 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.
- Background 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.
- Background 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.
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- Background 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.
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- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
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- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 3M™ Transbond™ Plus | Unknown | — | — |
| Subject | 3M™ Transbond™ XT | Unknown | — | — |
| Subject | GC Ortho Connect™ | Unknown | — | — |
Indications
No indication recorded.