The evidence for remineralization efficacy has been shown with CPP-ACP and CPP-ACFP in a variety of vehicles in laboratory (Cochrane et al., 2008) and human in situ experiments (Shen et al., 2001; Cai et al., 2007; Reynolds et al., 2008), as well as in randomized, controlled clinical trials (Andersson et al., 2007; Morgan et al., 2008; Bailey et al., 2009; Rao et al.,2009).
The CPP-ACP literature has been reviewed by several authors (Reynolds, 1998; Llena et al., 2009; Azarpazhooh, et al 2008; Neuhaus, et al 2009, Yengopal & Mickenautsch, 2009). Yengopal and Mickenautsch (2009), in a systematic review, concludes that, within the limitations of the systematic review with meta-analysis, results of the clinical in situ trials indicate a short-term remineralization effect of CPP-ACP. Additionally, the promising in vivo randomized controlled trials results suggest a caries-preventing effect for long-term clinical CPP-ACP use. Further randomized control trials are needed in order to confirm these initial results in vivo.
One randomized, controlled caries clinical trial of CPP-ACP assessed the impact of CPP-ACP in sugar-free gum relative to a control sugar-free gum. This trial demonstrated that the CPP-ACP gum significantly slowed progression and enhanced regression of caries compared with the control sugar-free gum (Morgan et al., 2008).
Three randomized, controlled clinical trials of post-orthodontic white-spot lesion regression by a CPP-ACP dental cream have been reported by Andersson et al. (2007), Bailey et al. (2009) and Brochner et al. (2011). Andersson, investigate and compare the effects of a dental cream containing complexes of casein phosphoprotein-amorphous calcium phosphate (CPP-ACP) and fluoride mouthwashes on the regression of white spot lesions, after debonding of fixed orthodontic appliances. Clinical scoring and laser fluorescence assessment suggested that both regimens could promote regression of white spot lesions. The visual evaluation suggested an aesthetically more favorable outcome of the amorphous calcium phosphate treatments.
A randomized, double-blind, crossover studies were conducted to investigate the potential of CPP-ACP added to hard candy confections to slow the progression of enamel subsurface lesions in an in situ model. Consumption of the control sugar confection resulted in significant demineralization (progression) of the enamel subsurface lesions. However, consumption of the sugar confections containing CPP-ACP did not result in lesion progression, but in fact in significant remineralization (regression) of the lesions. Remineralization by consumption of the sugar + 1.0% CPP-ACP confection was significantly greater than that obtained with the sugar-free confection (Walker, et al., 2010).
Other studies are not conclusive regarding the ability of remineralization products based on CPP-ACP. Beerens et al., (2010) analyzed the effect of casein phosphopeptide amorphous calcium fluoride phosphate paste on white spot lesions and dental plaque after orthodontic treatment: a 3-month follow-up, and concluded that no clinical advantage was observed for use of the CPP-ACFP paste supplementary to normal oral hygiene over the 12 weak follow up.
The CPP-ACP technology has also been demonstrated to significantly increase the levels of calcium and phosphate ions in supragingival plaque when delivered in a mouthrinse and to promote the remineralization of enamel subsurface lesions in situ. In fact, in a mouthrinse clinical study, the CPP-ACP technology was shown to be superior to other forms of calcium phosphate including un-stabilized ACP (Reynolds et al., 2003). These studies highlight the importance of the CPP in stabilizing the high levels of calcium and phosphate ions but also in delivering the ions to the tooth surface. Electron microscopic analysis of immunocytochemically stained thin sections of supragingival plaque samples showed that the CPP-ACP nanocomplexes were localized in the plaque matrix and on the surface of bacterial cells (Rose, 2000).
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