Staining of teeth and mucous membranes is a well-known side-effect with chlorhexidine mouthrinses in which dietary chromogens play an important rôle. The purpose of this study was to determine whether a co-polymer anti-adhesive agent would prevent staining by a low concentration chlorhexidine solution. Additionally, the possibility that an essential oil/phenolic rinse product may cause staining was investigated. The rinses studied were the anti-adhesive alone and combined with 0.02% chlorhexidine and the essential oil/phenolic rinse. These were positioned against a positive control rise, 0.2% chlorhexidine, and a negative control rinse, water. The study was a single blind 5-treatment, randomised Latin square cross-over design, incorporating balance for carry-over effects. 15 volunteers participated and on Day 1 of each study period were rendered stain free by scaling and polishing of the teeth. Oral hygiene was suspended and 8 x per day subjects rinsed under supervision, firstly with the allocated formulation and then with 10 ml of warm black tea. On Day 4, tooth and tongue staining was scored by area and intensity (colour). A washout period of at least 3 1/2 days was permitted between treatment periods when oral hygiene was resumed. Before the study and during washouts, volunteers practised tongue brushing. Tooth and tongue staining was significantly increased with 0.2% chlorhexidine compared to the essential oil/phenolic rinse which in turn was significantly increased compared to the other 3 rinses. The antiadhesive/chlorhexidine rinse produced no more staining than the anti-adhesive or water rise. However, the parallel plaque regrowth study suggests this inhibition of staining resulted from the vitiation of the chlorhexidine activity by the antiadhesive. The methodology would appear a simple and quick way of assessing the propensity of mouthrinses to cause extrinsic staining.
There are a large number of mouthrinse products available to the general public for use as adjuncts to oral hygiene. Many have not been evaluated and relatively few comparisons of products have been made. This study compared 4 mouthrinse products containing cetylpyridinium chloride (CPC), chlorhexidine, C31G, or triclosan with saline rinse included as a placebo control. Twenty dentate volunteers took part in this 4-day plaque regrowth study which had a single blind, randomized cross-over design balanced for residual effects. On day 1 of each study period, volunteers were rendered plaque free by a professional prophylaxis, suspended normal oral hygiene measures, and rinsed twice daily for 1 minute with 15 mL of the allocated rinse. On day 5, subjects were scored for disclosed plaque by plaque index and plaque area. By both measures the order of decreasing product efficacy was chlorhexidine, CPC and triclosan, C31G, and saline. All the differences in favor of the chlorhexidine product were highly significant as were those in favor of the other rinses compared to saline. It is concluded that the findings of this study reflect the actual chemical benefits of the products divorced from the indeterminate variable of toothbrushing.
The mere incorporation of an active ingredient in an oral hygiene product does not necessarily guarantee efficacy. As new formulations appear, it would seem prudent to at least screen for activity by comparison with an established product. The aim of this study was to compare a new 0.12% chlorhexidine containing rinse with a well researched 0.2% chlorhexidine rinse product. The rinses were firstly compared in vitro for dietary staining effects and in vivo for plaque inhibition. Both formulations in vitro produced progressive staining of acrylic specimens with increasing passages through a standard tea solution. The clinical investigation was a 3-treatment, randomised, double blind, crossover, 4-day plaque regrowth study, balanced for 1st and 2nd order residual effects and involving 24 volunteers. From a zero plaque baseline, volunteers suspended oral hygiene and rinsed 2 x per day with the allocated rinse. The chlorhexidine doses were 18 mg and 20 mg per rinse for the 0.12% and 0.2% formulations, respectively. Plaque was scored by area and index on day 5. The results showed that the 2 chlorhexidine rinses were similar in efficacy by comparison with the control rinse. These studies in vitro and in vivo indicate that the chlorhexidine in the new preparation is available and active and the product could find use in those preventive applications suggested for other chlorhexidine formulations.
Based on extensive literature for the correlation of this test in vitro with chlorhexidine anti-plaque activity and propensity to stain in vivo these ADS rinses will have the same anti-plaque efficacy and potential to cause stain as established chlorhexidine rinse products.
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