NCT04875000 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Borges BC, Borges JS, de Melo CD, Pinheiro IV, Santos AJ, Braz R, Montes MA
Efficacy of a novel at-home bleaching technique with carbamide peroxides modified by CPP-ACP and its effect on the microhardness of bleached enamel. Oper Dent. 2011 Sep-Oct;36(5):521-8. doi: 10.2341/11-013-L. Epub 2011 Aug 5.
Browning WD, Chan DC, Myers ML, Brackett WW, Brackett MG, Pashley DH
Comparison of traditional and low sensitivity whiteners. Oper Dent. 2008 Jul-Aug;33(4):379-85. doi: 10.2341/07-134.
Cardoso PC, Reis A, Loguercio A, Vieira LC, Baratieri LN
Clinical effectiveness and tooth sensitivity associated with different bleaching times for a 10 percent carbamide peroxide gel. J Am Dent Assoc. 2010 Oct;141(10):1213-20.
Pintado-Palomino K, Peitl Filho O, Zanotto ED, Tirapelli C
A clinical, randomized, controlled study on the use of desensitizing agents during tooth bleaching. J Dent. 2015 Sep;43(9):1099-1105. doi: 10.1016/j.jdent.2015.07.002. Epub 2015 Jul 6. Erratum in: J Dent. 2017 Jul;62:98.
Soares DG, Basso FG, Pontes EC, Garcia Lda F, Hebling J, de Souza Costa CA
Effective tooth-bleaching protocols capable of reducing H(2)O(2) diffusion through enamel and dentine. J Dent. 2014 Mar;42(3):351-8. doi: 10.1016/j.jdent.2013.09.001. Epub 2013 Sep 19.

Effect of Arginine and Nano-hydroxyapatite Solutions on Hypersensitivity and Color Changes of Bleached Enamel: a Randomized Controlled Trial

Clinical trial NCT04875000 - References