The dynamics of the oesophageal squamous epithelium 'normalisation' process in patients with gastro-oesophageal reflux disease treated with long-term acid suppression or anti-reflux surgery.

BACKGROUND: Proton pump inhibitors and laparoscopic anti-reflux surgery (LARS) offer long-term symptom control to patients with gastro-oesophageal reflux disease (GERD). AIM: To evaluate the process of 'normalisation' of the squamous epithelium morphology of the distal oesophagus on these therapies. METHODS: In the LOTUS trial, 554 patients with chronic GERD were randomised to receive either esomeprazole (20-40 mg daily) or LARS. After 5 years, 372 patients remained in the study (esomeprazole, 192; LARS, 180). Biopsies were taken at the Z-line and 2 cm above, at baseline, 1, 3 and 5 years. A severity score was calculated based on: papillae elongation, basal cell hyperplasia, intercellular space dilatations and eosinophilic infiltration. The epithelial proliferative activity was assessed by Ki-67 immunohistochemistry. RESULTS: A gradual improvement in all variables over 5 years was noted in both groups, at both the Z-line and 2 cm above. The severity score decreased from baseline at each subsequent time point in both groups (P < 0.001, all comparisons), attaining a normal level by 5 years. Corresponding decreases in Ki-67 expression were observed (P < 0.001, all comparisons). No significant differences were found between esomeprazole treatment and LARS. Neither baseline severity score nor Ki-67 expression predicted the risk of treatment failure. CONCLUSIONS: Five years of treatment is generally required before squamous epithelial cell morphology and proliferation are 'normalised' in patients with chronic GERD, despite endoscopic and symptomatic disease control. Control of the acid component of the refluxate seems to play the predominant role in restoring tissue morphology.

Long-term safety of proton pump inhibitor therapy assessed under controlled, randomised clinical trial conditions: data from the SOPRAN and LOTUS studies.

BACKGROUND: Control of chronic gastro-oesophageal reflux disease may be achieved either by anti-reflux surgery (ARS) or by long-term medical therapy with proton pump inhibitors (PPIs). The primary efficacy results of the SOPRAN study, comparing long-term omeprazole use with open ARS, and the LOTUS study, comparing long-term esomeprazole use with laparoscopic ARS, have been reported. A secondary objective of these studies was to address the long-term safety of these respective therapeutic strategies and thereby provide a valid scientific platform for assessing long-term PPI safety. AIM: To assess the safety of long-term PPI therapy with omeprazole and esomeprazole through analyses of data from the randomised SOPRAN and LOTUS studies. METHODS: Safety data were collected from patients during the 12-year period of the SOPRAN study (n = 298) and the 5-year period of the LOTUS study (n = 514). Reported serious adverse events (SAEs) and changes in laboratory variables were analysed. RESULTS: Across both studies, SAEs were reported at a similar frequency in the PPI and ARS treatment groups. Taking the time frames into consideration, the number of fatal SAEs in the two studies was low in both treatment groups. Laboratory results, including routine haematology and tests for liver enzymes, electrolytes, vitamin D, vitamin B12 , folate and homocysteine, showed no clinically relevant changes over time. As expected, gastrin and chromogranin A were elevated in the PPI groups, with the greatest increases observed in the first year. CONCLUSION: No major safety concerns arose during 5-12 years of continuous PPI therapy. (ClinicalTrials.gov: NCT00251927 and NCT00256737).

Clinical trial: factors associated with freedom from relapse of heartburn in patients with healed reflux oesophagitis--results from the maintenance phase of the EXPO study.

BACKGROUND: Ability to predict freedom from heartburn relapse during maintenance therapy for healed reflux oesophagitis may facilitate optimal treatment choices for individual patients. AIM: To determine factors predicting freedom from heartburn relapse during maintenance proton pump inhibitor therapy in patients with healed reflux oesophagitis. METHODS: This post-hoc analysis used data from the maintenance phase of the EXPO study (AstraZeneca study code: SH-NEG-0008); 2766 patients with healed reflux oesophagitis and resolved heartburn received once-daily esomeprazole 20 mg or pantoprazole 20 mg for 6 months. Multiple logistic regression analysis determined factors associated with freedom from heartburn relapse. RESULTS: Heartburn relapse rates were lower with esomeprazole than pantoprazole in all subgroups analysed. Esomeprazole treatment was the factor most strongly associated with freedom from heartburn relapse (odds ratio 2.08; P < 0.0001). Other factors significantly associated with freedom from heartburn relapse were Helicobacter pylori infection, greater age, non-obesity, absence of epigastric pain at baseline, pre-treatment nonsevere heartburn and GERD symptom duration < or =5 years. CONCLUSIONS: Several factors predict freedom from heartburn relapse during maintenance proton pump inhibitor therapy for healed reflux oesophagitis, the strongest being choice of proton pump inhibitor. These findings outline the importance of optimizing acid control and identifying predictors of relapse for effective long-term symptom management in reflux oesophagitis patients.

Clinical trial: factors associated with resolution of heartburn in patients with reflux oesophagitis--results from the EXPO study.

BACKGROUND: The ability to predict symptom response to reflux oesophagitis-healing therapy may optimize treatment decisions. AIM: To identify factors associated with heartburn resolution in patients receiving acid-suppressive therapy for reflux oesophagitis. METHODS: In this multicentre, randomized, double-blind trial (EXPO; AstraZeneca study code: SH-NEG-0008), patients with endoscopically confirmed reflux oesophagitis and reflux symptoms received once-daily proton pump inhibitor therapy [esomeprazole 40 mg (n = 1562) or pantoprazole 40 mg (n = 1589)] for >or=4 weeks. Factors associated with heartburn resolution after 4 weeks were identified by multiple logistic regression analysis. RESULTS: Esomeprazole therapy, positive Helicobacter pylori status and greater age were associated with an increased likelihood of heartburn resolution [odds ratio (95% confidence interval): 1.31 (1.12, 1.54), 1.44 (1.19, 1.74) and 1.013 (1.007, 1.019) per year, respectively; all P < 0.001]. Men and patients with no acid regurgitation or epigastric pain pre-treatment were also more likely to achieve heartburn resolution (all P < 0.05). CONCLUSIONS: The use of esomeprazole rather than pantoprazole increases the probability of achieving resolution of heartburn during reflux oesophagitis-healing therapy. Other factors, including H. pylori status, age, gender and symptom profile may be helpful in determining the likelihood of heartburn resolution in such patients.

Prolene Hernia System, Lichtenstein mesh and plug-and-patch for primary inguinal hernia repair: 3-year outcome of a prospective randomised controlled trial. The BOOP study: bi-layer and connector, on-lay, and on-lay with plug for inguinal hernia repair.

BACKGROUND: Dissection requirements differ between various methods for inguinal hernia repair, which may affect operation times, pain response and possibly recovery time. The objectives of this study were to establish if any differences concerning these aspects could be detected following three principally different techniques for primary inguinal hernia repair. METHODS: A total of 472 men between 30 and 75 years of age with primary inguinal hernias were included in a prospective controlled study and randomised to Lichtenstein mesh (L), PerFix Plug (P) or the Prolene Hernia System (PHS) procedure. All patients were seen and data were collected after 2 weeks, 3 months, 1 year and 3 years. RESULTS: The follow-up rates were 100, 99.8, 98.7 and 95.3%, respectively. The mean operation time was shorter for P (35.5 min, P < 0.001) and PHS (37.4 min, P < 0.02) versus L (40.4 min). More than 85% of the procedures were performed under local anaesthesia. There were no statistically significant differences between the groups concerning early or late complications, return to full functional ability, early pain response, analgesic consumption or the studied late-outcome parameters after 3 years of observation. Seven (1.5%) evenly distributed recurrences were registered. CONCLUSION: All of the techniques are suitable for operation under local anaesthesia. The PHS and P techniques can be performed with shorter operation times than the L method. Early and late outcomes are, however, comparable, with no significant differences concerning complication rates, return to full functional status and/or pain response.

Medical or surgical management of GERD patients with Barrett's esophagus: the LOTUS trial 3-year experience.

INTRODUCTION: The long-term management of gastroesophageal reflux in patients with Barrett's esophagus (BE) is not well supported by an evidence-based consensus. We compare treatment outcome in patients with and without BE submitted to standardized laparoscopic antireflux surgery (LARS) or esomeprazole treatment. METHODS: In the Long-Term Usage of Acid Suppression Versus Antireflux Surgery trial (a European multicenter randomized study), LARS was compared with dose-adjusted esomeprazole (20-40 mg daily). Operative difficulty, complications, symptom outcomes [Gastrointestinal Symptom Rating Scale (GSRS) and Quality of Life in Reflux and Dyspepsia (QOLRAD)], and treatment failure at 3 years and pH testing (after 6 months) are reported. RESULTS: Of 554 patients with gastroesophageal reflux disease, 60 had BE-28 randomized to esomeprazole and 32 to LARS. Very few BE patients on either treatment strategy (four of 60) experienced treatment failure during the 3-year follow-up. Esophageal pH in BE patients was significantly better controlled after surgical treatment than after esomeprazole (p = 0.002), although mean GSRS and QOLRAD scores were similar for the two therapies at baseline and at 3 years. Although operative difficulty was slightly greater in patients with BE than those without, there was no difference in postoperative complications or level of symptomatic reflux control. CONCLUSION: In a well-controlled surgical environment, the success of LARS is similar in patients with or without BE and matches optimized medical therapy.

Lead exposure and periodontitis in US adults.

BACKGROUND AND OBJECTIVE: Lead is known to have significant effects on bone metabolism and the immune system. This study tested the hypothesis that lead exposure affects periodontitis in adults. MATERIAL AND METHODS: This study used the data from the Third National Health and Nutrition Examination Survey (NHANES III, 1988-94). It analyzed data from 2500 men and 2399 women, 20-56 yr old, who received complete periodontal examination. Periodontitis was defined as the presence of > 20% of mesial sites with >or= 4 mm of attachment loss. Lead exposure was grouped into three categories: < 3; 3-7; and > 7 microg/dL. Covariates were cotinine levels, poverty ratio, race/ethnicity, education, bone mineral density, diabetes, calcium intake, dental visit, and menopause (for women). All analyses were performed separately for men and women and considering the effect design. Univariate, bivariate, and stratified analysis was followed by multivariable analysis by estimating prevalence ratios through poisson regression. RESULTS: After adjustment for confounders, the prevalence ratios, comparing those with a lead blood level of > 7 microg/dL to those with a lead blood level of < 3 microg/dL was 1.70 (95% confidence interval (CI): 1.02, 2.85) for men and 3.80 (95% CI: 1.66, 8.73) for women. CONCLUSION: The lead blood level was positively and statistically associated with periodontitis for both men and women. Considering the public health importance of periodontitis and lead exposure, further studies are necessary to confirm this association.

Esomeprazole 20 mg vs. pantoprazole 20 mg for maintenance therapy of healed erosive oesophagitis: results from the EXPO study.

BACKGROUND: Following initial healing of erosive oesophagitis, most patients require maintenance therapy to prevent relapse. AIM: To compare endoscopic and symptomatic remission rates over 6 months' maintenance therapy with esomeprazole or pantoprazole (both 20 mg once daily) in patients with healed erosive oesophagitis. METHODS: Patients with symptoms of gastro-oesophageal reflux disease and endoscopically confirmed erosive oesophagitis at baseline were randomized to receive esomeprazole 40 mg or pantoprazole 40 mg for up to 8 weeks. Patients with healed erosive oesophagitis and free of moderate/severe heartburn and acid regurgitation at 4 weeks or, if necessary, 8 weeks entered the 6-month maintenance therapy phase of the study. RESULTS: A total of 2766 patients (63% men; mean age 50 years) received esomeprazole 20 mg (n = 1377) or pantoprazole 20 mg (n = 1389) and comprised the intention-to-treat population. Following 6 months of treatment, the proportion of patients in endoscopic and symptomatic remission was significantly greater for those receiving esomeprazole 20 mg (87.0%) than pantoprazole 20 mg (74.9%, log-rank test P < 0.0001). Esomeprazole 20 mg produced a higher proportion of patients free of moderate to severe gastro-oesophageal reflux disease symptoms and fewer discontinuations because of symptoms than pantoprazole 20 mg (92.2% vs. 88.5%, P < 0.001). CONCLUSIONS: Esomeprazole 20 mg is more effective than pantoprazole 20 mg for maintenance therapy following initial healing of erosive oesophagitis and relief of gastro-oesophageal reflux disease symptoms.

A randomized comparative study of esomeprazole 40 mg versus pantoprazole 40 mg for healing erosive oesophagitis: the EXPO study.

AIM: To assess the efficacy of the 8-week therapy with esomeprazole 40 mg vs. pantoprazole 40 mg for healing erosive oesophagitis (EE) as part of a management study. METHODS: Patients had a history of gastro-oesophageal reflux disease symptoms (> or =6 months) and had suffered heartburn on at least 4 of the 7 days preceding enrollment. Endoscopies were performed to grade EE severity using the Los Angeles (LA) classification system at baseline, 4 and 8 weeks (if unhealed at 4 weeks). Heartburn severity was recorded by patients on diary cards. The primary end point was healing of EE by week 8 of treatment. RESULTS: Of 3170 patients randomized, the intent-to-treat population consisted of 3151 patients (63% male, mean age: 50.6 years, 27% Helicobacter pylori-positive). Esomeprazole 40 mg healed a significantly greater proportion of EE patients than pantoprazole 40 mg at both 4 weeks (life table estimates: esomeprazole 81%, pantoprazole 75%, P < 0.001) and 8 weeks (life table estimates: esomeprazole 96%, pantoprazole 92%, P < 0.001). The median time to reach sustained heartburn resolution was 6 days in patients receiving esomeprazole and 8 days with pantoprazole (P < 0.001). CONCLUSION: Esomeprazole 40 mg is more effective than pantoprazole 40 mg for healing EE and providing resolution of associated heartburn.

Esomeprazole 20 mg and lansoprazole 15 mg in maintaining healed reflux oesophagitis: Metropole study results.

INTRODUCTION: Esomeprazole, the first proton pump inhibitor to be developed as an optical isomer, has demonstrated more effective healing vs. omeprazole and lansoprazole in patients with reflux oesophagitis (RO). However, RO recurs in a high proportion (approximately 80%) of these patients within 12 months of initial therapy, highlighting the importance of maintenance treatment. Previous studies have shown esomeprazole to be effective as maintenance therapy in healed RO patients. AIM: This study was conducted to compare esomeprazole 20 mg once daily (o.d.) with lansoprazole 15 mg o.d. for the prevention of recurrence of RO. METHODS: 1391 patients with endoscopically verified RO (LA classification) were enrolled in this randomized, double-blind, parallel-group, multicentre trial. During the initial healing phase of the study, all patients received 4-8 weeks' open treatment with esomeprazole 40 mg: 1236 healed (identified by endoscopy at 4 and 8 weeks) and symptom-free (i.e. no heartburn or acid regurgitation) patients were randomized to 6 months' maintenance treatment with esomeprazole 20 mg o.d. or lansoprazole 15 mg o.d. Time to relapse (relapse of RO and/or discontinuation due to symptom recurrence) was analysed using a log-rank test. RESULTS: Esomeprazole maintained a significantly higher proportion of patients in remission than lansoprazole over the 6-month course of treatment (P < 0.0001, intention-to-treat analysis). After 6 months' treatment, 83% of esomeprazole recipients were in remission compared with 74% of lansoprazole recipients (life-table estimates). Esomeprazole gave a longer time to relapse than lansoprazole irrespective of baseline LA Grade, significantly so for baseline LA Grades B, C and D (P < 0.05 for each comparison). Significantly more patients were free from heartburn in the esomeprazole group compared with the lansoprazole group at 1, 3 and 6 months (P < 0.05). Significant differences at 6 months between esomeprazole 20 mg o.d. and lansoprazole 15 mg o.d. were also observed for control of epigastric pain and acid regurgitation (P < 0.05 and P < 0.001, respectively). Both treatment regimens were well tolerated. CONCLUSION: Esomeprazole 20 mg o.d. is a more effective maintenance treatment than lansoprazole 15 mg o.d. for symptom-free patients with healed RO.

Esomeprazole 20 mg and lansoprazole 15 mg in maintaining healed reflux oesophagitis: Metropole study results.

AIM: To compare the efficacy of esomeprazole, 20 mg once daily, vs. lansoprazole, 15 mg once daily, for the maintenance treatment of patients with healed reflux oesophagitis. METHODS: During the initial open healing phase, 1391 patients with endoscopically verified reflux oesophagitis and a history of heartburn, with or without acid regurgitation, received esomeprazole 40 mg for 4-8 weeks. Patients who were healed (identified by endoscopy at 4 or 8 weeks) and symptom free were then randomized to receive 6 months of treatment with esomeprazole, 20 mg once daily, or lansoprazole, 15 mg once daily. RESULTS: Esomeprazole, 20 mg once daily, maintained a significantly higher proportion of patients in remission than lansoprazole, 15 mg once daily, over 6 months [83% (95% CI, 80-86%) of esomeprazole recipients compared with 74% (95% CI, 70-78%) of lansoprazole recipients; P < 0.0001; life table estimates]. When data were analysed according to baseline Los Angeles grade classification, esomeprazole, 20 mg once daily, achieved consistently higher remission rates across all grades of disease severity, whereas the efficacy of lansoprazole decreased to a greater extent with increasing severity of reflux oesophagitis. CONCLUSION: Esomeprazole, 20 mg once daily, is more effective than lansoprazole, 15 mg once daily, in maintaining remission in patients with healed reflux oesophagitis.

Sugared soda consumption and dental caries in the United States.

Because of the complexity of the caries process, the potential cariogenicity of specific food items is difficult to assess. The purpose of this study was to investigate the associations between sugared soda consumption and caries. Dietary and dental examination data from the 1988-94 Third National Health and Nutrition Examination Survey (NHANES III) were used. From the food frequency questionnaire and 24-hour recall data, significant associations between DMFS and soda consumption were generally seen in persons over age 25. No differences in DMFS, relative to soda consumption, were seen in persons under age 25, or in analyses of dfs for children under age 12. The observed associations could be due to the cumulative effects of the long-term consumption of sugared soda. The absence of apparent effects of sugared soda consumption in younger people may also be related to the increased use of fluorides since the 1960s.

Third-molar removal patterns in an insured population.

BACKGROUND: The authors examined third-molar removal patterns in an insured population to see how these patterns compare with recommendations in the literature. METHODS: The source of treatment data was insurance claims for services rendered from July 1991 through December 1999; it included approximately 100 million dental procedures provided to about 7.4 million patients from all 50 states. The insured were public and private employees or retirees and their dependents. RESULTS: The authors found that third molars were the most commonly extracted permanent teeth, and they most often were removed from adolescents. Friday was the day of the week on which most extractions occurred, and the favored month was August, followed by July, December and June. Another important pattern revealed by the authors' analysis was that there was substantial variation among dental practices in whether patients had third molars removed and in the timing of the removal. They found that adolescent patients in some dental practices rarely were referred for third-molar removal, while in other practices, most or all had third molars removed. CONCLUSIONS: Third-molar removal patterns suggest that many third molars are not removed in response to acute pathology, and the observed variation in the likelihood and timing of these extractions reflects the lack of consensus on this topic in the dental literature. CLINICAL IMPLICATIONS: The apparent lack of consensus on third-molar removal should be resolved for the profession to maintain the confidence of the public that the recommended care is based on sound evidence.

Tungsten fluorides: syntheses and electrochemical characterization in the FLINAK molten salt eutectic.

The following tungsten fluorides have been synthesized by simple addition reactions or by reduction with tungsten metal at elevated temperature: KWF7, K2WF8, MWF6 (M = K, Na, Rb, Cs), K2WF7, M3WF8 (M = K, Na, Rb), and K3WF6. The compounds were characterized by their Raman spectra and by cyclic voltammetry in the molten FLINAK eutectic melt (46.5, 11.5, and 42.0 mol % of LiF, NaF, and KF, respectively) at 475-800 degrees C. X-ray crystal structures are reported for two new compounds K2WF7 and K3WF6. The crystals of K2WF7 were orthorhombic, space group Pnma (No. 62) with a = 9.800(2) A, b = 5.7360(11) A, c = 11.723(2) A, and Z = 4. Crystals of K3WF6 were cubic, space group Fm3 (No. 225) with a = b = c = 8.9160(10) A, Z = 4. Electrodeposition of tungsten metal on Pt from FLINAK, prepared by the addition of WF6 gas and metallic tungsten to the melt, is suggested to result from reduction of an equilibrium mixture of WF8(3-) and WF6(3-).

Adverse events associated with hepatitis B vaccine in U.S. children less than six years of age, 1993 and 1994.

PURPOSE: This study evaluated infrequent adverse reactions to hepatitis B vaccine by investigating the association of this vaccine with adverse health outcomes for U.S. children less than six years of age. The evaluation of the association between hepatitis B vaccine and chronic arthritis provides needed data, relevant to the Institute of Medicine's Report that there are inadequate data available to assess the causal relationship of hepatitis B vaccine to arthritis risk. METHODS: The 1993 (n = 5505 children) and 1994 (n = 6515 children) National Health Interview Survey (NHIS) datasets were analyzed to provide post-marketing surveillance data from probability samples of the U.S. population. Incident cases of adverse events were determined from the temporal association between the hepatitis B vaccination and the adverse events. Logistic regression modeling was used to adjust for potential confounding. RESULTS: Controlling for age, race, and gender simultaneously in the 1994 NHIS, hepatitis B vaccine was found to be associated with prevalent arthritis [odds ratio (OR) = 5.91, 95% confidence interval (CI) = 1.05-33.14], incident acute ear infections (OR = 1.60, 95% CI = 1.00-2.58), and incident pharyngitis/nasopharyngitis (OR = 1.41, 95% CI = 0.95-2.09). CONCLUSIONS: Evidence from this study suggests that hepatitis B vaccine is positively associated with adverse health outcomes in the general population of US children.

The impact of insurance on oral health.

Evidence from correlation and experimental studies supports the view that availability of dental insurance increases both utilization of services and oral health. These effects are most pronounced for individuals with middle or low incomes--those most in need of care. Defining optimal levels of care and the most effective distribution of resources remains, however, an evolving and still unanswered question.

Cost-effectiveness study of a school-based sealant program.

A nonprofit private dental clinic provides free dental treatment for children up to the age of eighteen years. In order to expand its services to reach more children, a school-based sealant program using dental auxiliary personnel was organized. This paper evaluated the performance of the school-based program during 1991 by comparing the costs of the school-based program with the costs of the sealants placed in the clinic in twelve months. Costs were calculated based on 1991 expenditures, and effectiveness rates were estimated from dental literature on sealants. The cost of saving one tooth-surface from decaying within a six-year period at the school and the clinic was $65 and $42 with an average sealing time per tooth surface of 18 and 12.5 minutes, respectively. Despite the relatively lower cost of personnel, the school program cost was 35 percent higher than at the clinic. Nevertheless, if hidden costs, such as transportation, time off work, and waiting time for those attending the clinic were considered, costs could be comparable or even higher for the clinic. The main goal of this paper is to explore a methodology to compare programs of different nature, and critically evaluate the results.

Age differences and changes in midline-crossing inhibition in the lower extremities.

BACKGROUND: The effects of crossing the body midline on the lower extremities of individuals 65 years of age and older was investigated. METHODS: The subjects were 10 individuals 65-79 years of age, 10 individuals 80 years and older, and 10 individuals 20-35 years. The total testing phase consisted of 2 sets of 30 trials per leg on 2 days. The subjects performed trials that involved movements ipsilaterally, contralaterally, and directly in front of the anterior superior iliac crest of the leg being tested. Reaction time and movement time scores were recorded. RESULTS: Individuals 65 years of age and older were found to exhibit slower reaction times to movements in a contralateral direction when compared with movements made in the ipsilateral direction whereas individuals 80 years of age and older were also found to exhibit slower reaction times to movements in a contralateral direction when compared with movements made in the midline and ipsilateral direction. CONCLUSIONS: These findings indicate that the effects of midline-crossing inhibition on the lower extremities reemerge in individuals 65 years and older, whereas in early development this effect disappears by 8 or 9 years of age.

Professionally applied topical fluoride and restorative care in insured children.

OBJECTIVES: This study evaluates the association between use of professionally applied topical fluoride and use of interproximal restorations in primary and permanent teeth of children. METHODS: Insurance claims from 15,190 children, for treatment provided by 1,556 different dentists, were analyzed to look for associations between frequency of use of professionally applied topical fluoride and use of interproximal restorations. The average follow-up period for the children included in the analysis was 5.3 years, with the range from 3.0 to 7.9 years. RESULTS: Both tabular and regression results failed to demonstrate an association between frequency of use of professionally applied topical fluoride and use of interproximal restorations in either the primary or permanent dentition. The most powerful predictor of restorative care for these children was the overall propensity of the dentist to place restorations in children. CONCLUSIONS: In this group of insured children, we were unable to find an association between the frequency of use of professionally applied topical fluoride and restorative care. Further, despite numerous recommendations that professionally applied topical fluorides should be used only in moderate- and high-caries children, approximately two-thirds of these children received topical fluoride at every recall visit, nearly two times per year.