The main purpose of this paper is to review the various methods used for evaluation of fluoride retention in saliva, plaque, and enamel following application of topical anti-caries treatments such as F dentifrices and F mouthwashes. Such methods monitor delivery of fluoride to the site of action, the mouth, and so can be regarded as assessing potential for treatment action. It is concluded that intra-oral fluoride measurements are appropriate to support bioequivalence claims for anti-caries treatments, provided that particular chosen methods have been calibrated against clinical data. Studies purporting to show superiority are of interest mechanistically, but links to caries are not sufficiently understood to define superiority claims. A wide variety of methods has been used for determination of the fluoride content of enamel. Of these, well-established methods such as the micro-drill and acid-etch procedures are appropriate for routine comparative testing, whereas sophisticated instrumental techniques such as SIMS are more appropriate for detailed mechanistic studies. Intra-oral pH measurements are also relevant to many topical treatments. Single-site determinations in plaque are preferred, but for comparative studies non-specific determinations may be adequate.
The aim of this exploratory study was to investigate the influence of several factors on changes in the mineral content of carious enamel lesions treated in situ. The study involved 36 adult volunteers who used either a non-fluoride toothpaste or one of two fluoride toothpastes (1000 or 1500 ppm F). Human enamel specimens were prepared and attached to partial dentures as described previously (Schäfer, 1989) and treated in situ for between three and six weeks. The mineral content of lesions was determined by microradiography and computerized densitometry. The factors investigated in this study included study length, frequency of treatment, trial design, patient compliance, patient diet, and previous caries experience of the patient. The effects observed were small, relative to that of the treatment, and not statistically significant (p greater than 0.05). However, the trends in the data were all as would be intuitively predicted. Study duration correlated positively with observed lesion mineral content. Lesions worn by panelists using a fluoride toothpaste for six weeks contained greater levels of mineral with respect to placebo than did those in panelists on a three-week study. The residual variations in the three phases of the study were found to be similar, suggesting that there is no advantage in these studies having a cross-over design. Brushing frequency also correlated positively with observed lesion mineral content, with panelists brushing three times per day with a fluoridated dentifrice having lesions with greater levels of mineral, with respect to placebo, than those brushing twice per day. Overall, no clear relationship between reported diet and changes in lesion mineral levels was apparent.(ABSTRACT TRUNCATED AT 250 WORDS)
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