A pleiotropy scan to discover new susceptibility loci for pancreatic ductal adenocarcinoma.

Pleiotropic variants (i.e., genetic polymorphisms influencing more than one phenotype) are often associated with cancer risk. A scan of pleiotropic variants was successfully conducted ten years ago in relation to pancreatic ductal adenocarcinoma susceptibility. However, in the last decade, genetic association studies performed on several human traits have greatly increased the number of known pleiotropic variants. Based on the hypothesis that variants already associated with a least one trait have a higher probability of association with other traits, 61,052 variants reported to be associated by at least one genome wide association study (GWAS) with at least one human trait were tested in the present study consisting of two phases (discovery and validation), comprising a total of 16,055 pancreatic ductal adenocarcinoma (PDAC) cases and 212,149 controls. The meta-analysis of the two phases showed two loci (10q21.1-rs4948550 (P=6.52×10-5) and 7q36.3-rs288762 (P=3.03×10-5) potentially associated with PDAC risk. 10q21.1-rs4948550 shows a high degree of pleiotropy and it is also associated with colorectal cancer risk while 7q36.3-rs288762 is situated 28,558 base pairs upstream of the Sonic Hedgehog (SHH) gene, which is involved in the cell differentiation process and PDAC etiopathogenesis. In conclusion, none of the single nucleotide polymorphisms (SNPs) showed a formally statistically significant association after correction for multiple testing. However, given their pleiotropic nature and association with various human traits including colorectal cancer, the two SNPs showing the best associations with PDAC risk merit further investigation through fine mapping and ad hoc functional studies.

Prognostic role of FDG PET-derived parameters in preoperative staging of endometrial cancer. / Función pronóstica de los parámetros derivados de FDG PET en la estadificación preoperatoria del cáncer de endometrio.

PURPOSE: To investigate the preoperative prognostic role of 18F-FDG PET/CT in patients with endometrial carcinoma (EC). METHODS: 18F-FDG PET/CT was performed in 57 patients for EC preoperative staging. Maximum and mean standardized uptake values (SUVmax, mean), metabolic tumor volume (MTV) and total lesion glycolysis (TLG) of primary tumors, at different thresholds of 40%, 50%, 60% (40-50-60), were evaluated and compared with anatomopathological features. The diagnostic performance of PET-parameters (categorized by ROC analysis) in discriminating low-intermediate and high-risk disease and the prognostic role on survival (overall survival -OS; disease free survival - DFS) was evaluated. RESULTS: The categorized TLG40-50-60 were the only parameters related to FIGO stage I versus II-III-IV (p = 0.0035 for all). The cut-off values for risk stratification were 83.69, 61.81 and 41.32, respectively (sensitivity: 60.00%; specificity; 71.43% for all parameters). Pathological stage 1 (pT1) of the primary tumor was predicted by MTV60 and TLG40-50 (p = 0.0328, 0.0240, 0.0147, respectively). The optimal thresholds were 7.795, 99.55 and 77.58, respectively (sensitivity: 38.46%, 53.85% and 53.85%, respectively; specificity: 88.64%, 79.55% and 81.82%, respectively). SUVmax and SUVmean40-50-60 were the only parameters discriminating endometrioid from non-endometrioid subtype. The corresponding sensitivity was 64.86% and 62.16% for SUVmax and SUVmean 50-60 and 62.16% for SUVmean40; specificity was 70.00% for all parameters. The mean (SD) OS was 79.77% (3.34%) and the mean DFS was 77.89% (3.73%). The tumor type was the only variable significantly associated with OS (p = 0.0486). TLG50 > 77.58 cm3 was the only variable associated with a higher risk of relapse (p = 0.0472). CONCLUSION: TLG40-50-60 and MTV60 of primary EC have prognostic value in discriminating FIGO and pathological staging. These results suggest a possible role of these parameters in predicting EC aggressiveness, thus improving the preoperative characterization of endometrial cancer.

Prevention strategies in palmar-plantar erythrodysesthesia onset: the role of regional cooling.

OBJECTIVE: Palmar-plantar erythrodysesthesia (PPE) is a characteristic cutaneous toxicity associated with pegylated liposomal doxirubicin (PLD). Different therapies have been proposed to alleviate PPE onset. We performed a prospective study to evaluate preventive strategies to reduce PPE incidence in patients treated for gynecologic cancers. METHODS: Fifty-three patients were treated from 2001 to 2006 with PLD as single agent therapy or in combination with carboplatin or paclitaxel. PLD dosages were in the range of 30-50 mg/m2 every 21-28 days. All patients received premedication with dexamethasone and pyridoxine. Twenty-eight patients received application of ice packs on extremities during PLD infusion. RESULTS: PPE was observed in 11 patients (20.8%). PLD administration as single agent or in combination and schedule of PLD therapy did not affect PPE incidence. A significant reduction in PPE onset was observed if PLD dosage was 30-35 mg/m2 (p=0.03) and when patients were submitted to regional cooling protocol (p=0.0097). CONCLUSIONS: The use of ice packs around wrists and ankles is a simple and well tolerated prevention strategy and its efficacy is demonstrated in this study.

Systematic review and meta-analysis of metal versus plastic stents for preoperative biliary drainage in resectable periampullary or pancreatic head tumors.

BACKGROUND: Preoperative biliary drainage (PBD) with stenting increases complications compared with surgery without PBD. Metallic stents are considered superior to plastic stents when considering stent-related complications. Aim of the present systematic review and meta-analysis is to compare the rate of endoscopic re-intervention before surgery and postoperative outcomes of metal versus plastic stents in patients with resectable periampullary or pancreatic head neoplasms. METHODS: We conducted a bibliographic research using the National Library of Medicine's PubMed database, including both randomized controlled trials (RCTs) and non-RCTs. Quantitative synthesis was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Statistical heterogeneity was assessed using the I(2) tests. RESULTS: One RCT and four non-RCTs were selected, including 704 patients. Of these, 202 patients (29.5%) were treated with metal stents and 502 (70.5%) with plastic stents. The majority of patients (86.4%) had pancreatic cancer. The rate of endoscopic re-intervention after preoperative biliary drainage was significantly lower in the metal stent (3.4%) than in the plastic stent (14.8%) group (p < 0.0001). The rate of postoperative pancreatic fistula was significantly lower in the meta stent group as well (5.1% versus 11.8%, p = 0.04). The rate of post-operative surgical complications and of - post-operative mortality did not differ between the two groups. CONCLUSIONS: Although the present systematic review and meta-analysis demonstrates that metal stent are more effective than plastic stents for PBD in patients with resectable periampullary tumors, randomized controlled trials are needed in order to confirm these data with a higher level of evidence.

Anagrelide metabolite induces thrombocytopenia in mice by inhibiting megakaryocyte maturation without inducing platelet aggregation.

OBJECTIVE: The mechanism for anagrelide's potent platelet lowering activity in human subjects is not well defined. Studies related to anagrelide function have been hampered by its lack of activity in nonhuman primates and water insolubility. In an effort to define the mechanism whereby anagrelide exerts its therapeutic effect, we identified a water-soluble metabolite (anagrelide.met). The availability of anagrelide.met allowed, for the first time, parallel in vitro and in vivo animal studies centered on the mechanisms by which anagrelide lowers platelet levels. MATERIALS AND METHODS: The effects of anagrelide.met on proliferation and maturation of mega-karyocytes (MKs) as well as platelet production were studied both in vitro and in vivo. RESULTS: Anagrelide.met is capable of blocking in vitro MK migration by 20% to 40%. At 100 ng/mL, anagrelide.met selectively blocked in vitro MK maturation, resulting in a 50% decrease in the total number of CD41a(+) MKs, corresponding with a 30% decrease in MK ploidy by day 10 and a 60% decrease by day 20. Daily intraperitoneal injections of anagrelide.met 100 microg into BALB/c mice was sufficient to significantly decrease platelet counts within 24 to 48 hours, stabilizing to 40 to 50% of normal levels by day 5. This was associated with a 45% decrease in the number of developing MKs and an increase in thrombopoietin levels. Anagrelide.met did not alter WBC counts, hematocrit, or bleeding time, or lead to any apparent signs of toxicity. Furthermore, unlike the parent anagrelide compound, anagrelide.met did not inhibit ADP-induced platelet aggregation even at high concentrations (10 microg/mL). CONCLUSIONS: We describe a cross-species reactive anagrelide metabolite that selectively inhibits MK maturation and migration, lowering platelet levels without influencing platelet aggregation.

A comparison between different methods for the determination of reduced and oxidized glutathione in mammalian tissues.

In this study, three rapid assay techniques for the determination of glutathione, one enzymatic, one fluorometric and one newly patented colorimetric method, were compared by measuring reduced (GSH) and oxidized (GSSG) glutathione in guinea-pig heart and liver. The HPLC technique was used as a standard, since it is considered the most reliable assay method. In heart, all methods measured the same levels of GSH (about 1 mumole/g wet tissue), whereas in liver the fluorometric assay gave GSH levels about half as high as those measured by the other methods (about 3 vs. 7 mumoles/g wet tissue). Conversely, the fluorometric assay grossly overestimated GSSG concentration (by 5 to 8 times) in both heart and liver. These results confirm previous doubts about the use of the fluorometric technique for GSSG determination in mammalian tissues and also raise some questions about its use for the measurement of GSH in liver. In this tissue, the GSH concentration determined by the fluorometric method was shown to be inversely correlated with the size of the sample, suggesting the presence of some quenching material.

Infliximab in treatment of Crohn's disease: the Milan experience.

BACKGROUND: Efficacy of infliximab in treatment of patients with moderate-to-severe refractory and fistulizing Crohn's disease has been shown in controlled clinical trials. Moreover, audit data from North America and North Europe have confirmed efficacy in clinical practice comparable to that in clinical trials. AIM: To report clinical experience using infliximab in treatment of Crohn's disease in Italy, comparing efficacy and safety with those reported in clinical trials and other published series. PATIENTS AND METHODS: The study population comprised 63 patients (31 males and 32 females, median age 33 years) treated with infliximab for refractory/inflammatory (31 patients) and/or fistulizing Crohn's disease (32 patients). All patients received an infusion of infliximab at a dose of 5 mg/kg at weeks 0, 2 and 6. After the first infusion, clinical and laboratory assessments were repeated at weeks 2, 6 and 10. For refractory inflammatory Crohn's disease, clinical remission was defined as a Crohn's Disease Activity Index of < or = 150 at each scheduled visit, clinical response as a reduction in the Crohn's Disease Activity Index score of > or = 70 points in comparison to baseline. For fistulizing Crohn's disease, a complete response was defined as closure of any draining fistulae at week 10. A fistula was defined as closed when it no longer drained despite gentle finger pressure. A partial response was defined as reduction in number, size or drainage of fistulae, at the same visit. RESULTS: According to an intention-to-treat evaluation on the 31 patients with refractory/inflammatory Crohn's disease, at week 2, 42.5% (14 patients) had a clinical response and 31.3% of patients (10 patients) were in clinical remission. At week 10 (4 weeks after the end of third infusion), 80.6% (25 patients) had a clinical response and 71% (22 patients) were in clinical remission and 14/19 (74%) had discontinued steroid treatment. Of the 32 patients with fistulizing Crohn's Disease, 15 (46.9%) had a complete response, 8 (25%) a partial response, and 9 (28.1%) no response at week 10 check-up. The incidence of side-effects was low (16%) and not influenced by concurrent immunomodulatory therapy. CONCLUSION: The present experience with infliximab in clinical practice confirms its efficacy, in particular in inflammatory/refractory Crohn's disease and its safety, at least, in short-term follow-up.

The diagnosis of dementia: demographic characteristics.

The demographic characteristics of 242 clinic outpatients evaluated for dementia were examined. Each individual received a comprehensive assessment of medical status, psychological functioning, and social abilities. Diagnoses were arrived at by consensus, and appropriate treatment plans and follow-up recommendations were generated, with comprehensive feedback provided to family members and other caregivers. The results of this study help increase our knowledge of the characteristics of individuals with Alzheimer's disease, multi-infarct dementia, or other related disorders.

Can Joel-Cohen incision and single layer reconstruction reduce cesarean section morbidity?

OBJECTIVE: To compare an innovative cesarean section based on Joel-Cohen incision with the traditional Pfannenstiel technique in terms of operative data and post-operative recovery. METHOD: Out of 158 randomized patients, 83 patients underwent the innovative cesarean section (Joel-Cohen incision, one-layer locked uterine suture, no peritoneization) and 75 the traditional operative approach (Pfannenstiel incision, double layer closure of the uterus, visceral and parietal peritoneization). Operative data and post-operative morbidity were compared; sample size was calculated to detect a 13% difference in the occurrence of post-operative fever with a statistical power of 80%. RESULT: Post-operative fever was not different in the two groups. Total operating time was shorter with the innovative technique: 31.6 +/-1.38 min vs. 44.4+/-1.44 (P=0.0001) and fewer sutures were used: 3.6+/-0.13 vs. 6+/-0.13 (P=0.001). Patients operated by the new technique began moving sooner and intestinal function restarted earlier. CONCLUSION: The proposed technique made for shorter operating times and faster recovery but no decrease in puerperal morbidity.

Anticalculus efficacy of three dentifrices.

PURPOSE: To evaluate the anticalculus effect of three commercial dentifrices. MATERIALS AND METHODS: A 12-week independent and double-blind clinical study was conducted on a population of calculus-forming adult male and female subjects in Budapest, Hungary to directly compare the anticalculus efficacy of three commercially-available dentifrices, as compared to a placebo dentifrice. The three commercially-available anticalculus dentifrices compared in this clinical study to a 0.243% sodium fluoride/silica placebo dentifrice were as follows: (1) A dentifrice containing 1.3% soluble pyrophosphate and 1.5% of a PVM/MA copolymer in a 0.243% sodium fluoride/silica base. (2) A dentifrice containing 0.3% triclosan and 2% of a PVM/MA copolymer in a 0.243% sodium fluoride/silica base. (3) A dentifrice containing 0.3% triclosan and 0.75% zinc citrate in a 1.14% sodium monofluorophosphate/silica base. RESULTS: All three anticalculus dentifrices provided statistically significant reductions in supragingival calculus formation, as compared to a placebo dentifrice, after 12 weeks of use. The reductions in supragingival calculus formation ranged from 39% to 55%, as compared to a placebo dentifrice, for the three commercially-available anticalculus dentifrices. There was no statistically significant difference among the three commercially-available dentifrices with regard to anticalculus efficacy.

Clinical comparison of the anticalculus effect of two mouthrinses.

A three-month, double-blind clinical study was conducted to compare the effects of supragingival calculus deposits of a mouthrinse containing soluble pyrophosphate and a copolymer of methoxyethylene and maleic acid, as compared to a mouthrinse containing only soluble pyrophosphate and a placebo mouthrinse. Male and female adult subjects were stratified into three balanced groups according to baseline calculus scores obtained from a pre-test period. They received an oral prophylaxis and were assigned to the use of one of the three test mouthrinses. All subjects used a commercially available dentifrice containing 0.76% sodium monofluorophosphate in a silica base. The results from the three-month calculus examination indicated that the soluble pyrophosphate/copolymer mouthrinse reduced supragingival deposits by 31.70% (P less than 0.03), as compared to the placebo mouthrinse. The mouthrinse containing only soluble pyrophosphate did not provide a statistically significant reduction in calculus deposits, as compared to the placebo mouthrinse.

A critical review of the 10 pivotal caries clinical studies used in a recent meta-analysis comparing the anticaries efficacy of sodium fluoride and sodium monofluorophosphate dentifrices.

The 10 pivotal caries clinical studies employed in a recent meta-analysis to compare the anticaries efficacy of sodium fluoride (NaF) and sodium monofluorophosphate (MFP) dentifrices were subjected to a critical review. When reporting the meta-analysis, the author (Johnson) considered these 10 pivotal caries clinical studies as "head-to-head" comparisons of NaF and MFP dentifrices. For the most part, it is difficult to find any common denominator among these 10 caries clinical studies since there were so many diverse factors associated with them. The 10 pivotal studies were conducted over a 20-year period of time in many different geographic areas of the world, using different protocols and study designs, different clinical examiners and caries assessment criteria, as well as evaluating commercially outdated or specially formulated dentifrices. Any attempt to integrate the results from these 10 studies is further complicated by the diversity of statistical methodology used to evaluate the results obtained from the studies. Also, in two of the 10 studies, the comparison of the fluoride dentifrices was obscured by the fact that the participating children used a fluoride mouthrinse during the course of the study. In any case, when all relevant dentifrice comparisons are made, the results of a critical review of the 10 pivotal ("head-to-head") caries clinical studies indicate the following: (1) In three of the studies (Gerdin/Zacherl/Forsman), depending upon how the data is viewed, it can either be shown that NaF dentifrices are favored over MFP dentifrices or that MFP dentifrices are favored over NaF dentifrices. (2) In one of the studies (Edward & Torell), the results are published only in abstract form and a full report of the study is not available. (3) In one of the studies (Koch, Petersson, Kling & Kling) it is reported that MFP dentifrices are favored over NaF dentifrices. (4) In two of the studies (Edlund & Koch, Koch et al) it is reported that NaF dentifrices are favored over MFP dentifrices. However, in both of these studies, there were serious imbalances in baseline caries status favoring the NaF dentifrice groups over the MFP dentifrice groups. In other words, the children using the MFP dentifrices were more prone to caries formation during the course of these studies than the children using the NaF dentifrices. Further, in these two studies there is a serious question regarding the soluble fluoride level of the commercially available MFP dentifrice that was used.(ABSTRACT TRUNCATED AT 400 WORDS)

Effects of two fluoride dentifrices containing triclosan and a copolymer on calculus formation.

A 12-week, double-blind, parallel and unsupervised clinical study was conducted to compare the effects on supragingival calculus formation of two dentifrices containing triclosan (Irgacare MP) and a copolymer of methoxyethylene and maleic acid (Gantrez) as compared to a placebo dentifrice. All 147 adult male and female subjects completed the study. Subjects were stratified into three balanced groups on the basis of their Volpe-Manhold index calculus scores as obtained from a 3-month pre-test period using a placebo dentifrice. After a complete oral prophylaxis, subjects were assigned to the use of either the placebo dentifrice, a dentifrice containing 0.3% triclosan and 2.0% of a copolymer in a 0.243% sodium fluoride silica base, or a dentifrice containing 0.3% triclosan and 2.0% of a coplymer in a 0.76% sodium monofluorophosphate alumina base. Subjects, after brushing with their assigned dentifrice and soft-bristled toothbrush for 12 weeks, were evaluated by the examining dentist for supragingival calculus formation using the Volpe-Manhold assessment method. These examinations showed that the dentifrice containing 0.3% triclosan/2.0% copolymer in a 0.243% sodium fluoride silica base reduced supragingival calculus deposits by 23.12% and the dentifrice containing 0.3% triclosan/2.0% copolymer in a 0.76% sodium monofluorophosphate alumina base reduced supragingival calculus deposits by 26.15%. Both of these reductions in supragingival calculus were compared to the placebo dentifrice and were statistically significant at the 99% level of confidence.

Desensitizing efficacy of a new dentifrice containing 5.0% potassium nitrate and 0.454% stannous fluoride.

PURPOSE: To evaluate the relative effectiveness provided by a new dentifrice containing 5.0% potassium nitrate and 0.454% stannous fluoride in a silica base (Colgate Sensitive Maximum Strength) for reducing dentin hypersensitivity over an 8-wk period, as compared to that provided by a commercially-available antihypersensitivity dentifrice containing 5.0% potassium nitrate and 0.76% sodium monofluorophosphate in a dicalcium phosphate base (Fresh Mint Sensodyne dentifrice). MATERIALS AND METHODS: To qualify for participation in this examiner-blind study, male and female adults from the San Francisco, California area were required to present with tactile and air blast dentin hypersensitivity in at least 2 non-molar teeth at two examinations, spaced 1 wk apart. Qualifying subjects were randomized into two treatment groups, which were balanced for gender, age, and baseline sensitivity scores. Subjects were provided with a soft-bristled toothbrush. Examinations for tactile and air blast sensitivity were repeated after 4 wks' use of the study dentifrices, and again after 8 wks' usage. RESULTS: 101 subjects complied with the protocol, and completed the entire study. After 4 wks, subjects assigned to the Colgate Sensitive Maximum Strength group exhibited a statistically significant improvement over the Fresh Mint Sensodyne dentifrice group with respect to tactile sensitivity scores, and a statistically significant improvement over the Sensodyne dentifrice group with respect to air blast sensitivity scores. Correspondingly significant improvements were presented after 8 wks. Thus, the results of this examiner-blind clinical study support the conclusion that Colgate Sensitive Maximum Strength dentifrice provided superior levels of control of tactile and air blast sensitivity than did the clinically tested, commercially-available Sensodyne anti-hypersensitivity dentifrice.

Clinical efficacy of an anticalculus fluoride dentifrice containing triclosan and a copolymer: a 6-month study.

A 6-month, double-blind, parallel and unsupervised clinical study was conducted to compare the effects on supragingival calculus formation of a dentifrice containing 0.3% triclosan and 2.0% of a copolymer in a 0.243% sodium fluoride/silica base, as compared to a placebo dentifrice containing 0.243% sodium fluoride in a silica base. Subjects were initially stratified into two balanced groups based on their Volpe-Manhold calculus index scores that were obtained from a 3-month pre-test period using a placebo dentifrice. All subjects received an oral prophylaxis and were assigned to the use of either the fluoride/triclosan/copolymer dentifrice or the placebo dentifrice. Seventy adult male and female subjects completed the entire 6-month study. The results after 3-months' use of their respective dentifrices indicated that the subjects using the fluoride/triclosan/copolymer dentifrice had 26.34% less supragingival calculus formation than the subjects using the placebo dentifrice. This reduction in supragingival calculus was significant at the 99% level of confidence. The results after 6 months indicated that the subjects using the fluoride/triclosan/copolymer dentifrice had 36.27% less supragingival calculus formation than the subjects using the placebo dentifrice. This reduction was significant at the 99% level of confidence.

Effect of a dentifrice containing triclosan and a copolymer on plaque formation: a 6-week clinical study.

A 6-week, double-blind, clinical study was conducted to determine the effect on plaque formation of a dentifrice containing 0.3% triclosan and 2% of a copolymer of methoxyethylene and maleic acid as compared to a placebo dentifrice. Ninety-one male and female adult subjects with baseline Quigley-Hein Plaque Index scores of 1.5 or greater were entered into the study. Eighty-six subjects completed the entire 6 weeks of the study. Subjects were initially stratified into two balanced groups using their baseline Plaque Index score and each group was then randomly assigned to the use of one of the two test dentifrices. All subjects received an oral prophylaxis at the start of the study. Subjects were given either the triclosan/copolymer dentifrice or the placebo dentifrice and a soft-bristled toothbrush for home use and were instructed to brush their teeth twice daily (morning and evening) for 1 minute at each toothbrushing. At the end of the 2, 4 and 6 weeks' use of their assigned dentifrice, the subjects had their teeth evaluated for plaque formation. The results indicated that the group assigned to the triclosan/copolymer dentifrice had 11.89%, 11.83% and 20.01% less plaque formation after 2, 4 and 6 weeks' use of the dentifrices, respectively, than the group assigned to the placebo dentifrice. All reductions in plaque formation were statistically significant at the 97% level of confidence or greater. The effect was more pronounced on the tooth surfaces that had the heaviest plaque formation.(ABSTRACT TRUNCATED AT 250 WORDS)

Anticalculus effect of a fluoride dentifrice containing triclosan and a copolymer.

A 3-month, double-blind, parallel and unsupervised clinical study was conducted to compare the effects on supragingival calculus formation of a dentifrice containing 0.3% triclosan and 2.0% of a copolymer, as compared to a placebo dentifrice. Subjects were initially stratified into two balanced groups based on their Volpe-Manhold Index calculus scores obtained from a 3-month pre-test period using a placebo dentifrice. All subjects received an oral prophylaxis and were assigned to the use of either a dentifrice containing 0.3% triclosan and 2.0% of a copolymer in a 0.243% sodium fluoride/silica base or a placebo dentifrice containing 0.243% sodium fluoride in a silica base. A total of 79 adult male and female subjects completed the study. The results after 3-months' use of their respective dentifrices indicated that the subjects using the triclosan/copolymer dentifrice had 26.34% less supragingival calculus formation than the subjects using the placebo dentifrice. This reduction in supragingival calculus was significant at greater than 97% level of confidence.

Desensitizing efficacy of Colgate Sensitive Maximum Strength and Fresh Mint Sensodyne dentifrices.

PURPOSE: To investigate the relative effectiveness provided by a new dentifrice containing 5.0% potassium nitrate and 0.454% stannous fluoride in a silica base (Colgate Sensitive Maximum Strength dentifrice) for reducing dentin hypersensitivity over an 8-wk period, as compared to that provided by a commercially-available antihypersensitivity dentifrice containing 5.0% potassium nitrate and 0.76% sodium monofluorophosphate in a dicalcium phosphate base (Fresh Mint Sensodyne dentifrice). MATERIALS AND METHODS: To qualify for participation in this examiner-blind clinical study, male and female adults from the central New Jersey area were required to present with tactile and air blast dentin hypersensitivity in at least two non-molar teeth at two examinations, spaced 1 wk apart. Qualifying subjects were randomized into two treatment groups, which were balanced for gender, age, and baseline sensitivity scores. Subjects were provided with a soft-bristled toothbrush. Examinations for tactile and air blast sensitivity were repeated after 4 wks' use of the study dentifrices, and again after 8 wks' usage. 97 subjects complied with the protocol, and completed the entire study. RESULTS: After 4 wks, subjects assigned to the Colgate Sensitive Maximum Strength dentifrice group exhibited a statistically significant improvement over the Sensodyne dentifrice group with respect to tactile sensitivity scores, and a statistically significant improvement over the Sensodyne dentifrice group with respect to air blast sensitivity scores. Correspondingly significant improvements were presented after 8 wks. Thus, the results of this examiner-blind clinical study support the conclusion that the Colgate Sensitive Maximum Strength dentifrice containing 5.0% potassium nitrate and 0.454% stannous fluoride in a silica base provided superior levels of control of tactile and air blast sensitivity than the clinically tested, commercially-available anti-hypersensitivity dentifrice Sensodyne dentifrice containing 5.0% potassium nitrate and 0.76% sodium monofluorophosphate in a dicalcium phosphate base.

The enhanced anticaries efficacy of a sodium fluoride and dicalcium phosphate dihydrate dentifrice in a dual-chambered tube. A 2-year caries clinical study on children in Brazil.

PURPOSE: To clinically evaluate and compare a dentifrice system in a dual-chambered tube, wherein one chamber contained sodium fluoride in a silica base and the other chamber contained dicalcium phosphate dihydrate (Test Dentifrice delivering 0.243% sodium fluoride), to a dentifrice containing 0.243% sodium fluoride in a silica base (Positive Control Dentifrice). MATERIALS AND METHODS: This study was conducted in harmony with the published 1988 American Dental Association guidelines for studies geared toward the comparison of fluoride dentifrices. This 2-yr caries clinical study employed a double-blind, parallel-group design, and involved 6-10 yr-old children from the metropolitan area of Maceio, Alagoas, Brazil. Qualifying subjects were stratified according to age and sex, and were randomly assigned to the two treatment groups, with multiple subjects in the same household all assigned to the dentifrice randomly allocated to the first among them. Caries examinations were conducted in accordance with U.S. Food and Drug Administration guidelines for the clinical evaluation of drugs to prevent dental caries. One calibrated examiner performed all the measurements. After treatment assignment, study participants were instructed to brush their teeth at home with their assigned dentifrice at least twice daily. Brushing instructions were reinforced by indoctrination in proper oral hygiene techniques by dental professionals, supplemented by pamphlets supplied by the sponsor and yearly mailings to participants, emphasizing good oral hygiene and the need to enforce compliance with the study. Post-baseline examinations were performed after 1 yr of product use, and again after 2 yrs of product use. RESULTS: Two thousand four hundred thirty-two (2,432) subjects completed this 2-yr study. For these subjects, the mean caries scores (DMFS, decayed, missing and filled tooth surfaces) at baseline were 3.84 for the Test Dentifrice group, and 4.06 for the Positive Control Dentifrice group. For caries increments after 1 yr, the respective means were 2.02 for the Test Dentifrice group and 2.12 for the Positive Control Dentifrice group. Finally, after 2 yrs, the mean caries increments were 4.30 for the Test Dentifrice group, and 4.83 for the Positive Control Dentifrice group. No statistically significant difference was indicated between the treatment groups at baseline or between the 1-yr caries increment scores. However, there was a statistically significant difference in the 2-yr caries increment scores between the treatment groups. Relative to the Positive Control Dentifrice group, the Test Dentifrice group presented a 10.97% reduction in caries increment scores at 2 yrs. In accordance with the procedures and standards provided by the published guidelines of the American Dental Association for the comparison of the anticaries efficacy of fluoride dentifrices, the results of this study support the conclusion that the dentifrice system in a dual-chambered tube, wherein one chamber contained sodium fluoride in a silica base and the other chamber contained dicalcium phosphate dihydrate, delivering 0.243% sodium fluoride, provided a superior level of anticaries efficacy than did the dentifrice containing 0.243% sodium fluoride in a silica base.

The enhanced anticaries efficacy of a sodium fluoride and dicalcium phosphate dihydrate dentifrice in a dual-chambered tube. A 2-year caries clinical study on children in the United States of America.

PURPOSE: To clinically evaluate and compare a dentifrice system in a dual-chambered tube, wherein one chamber contained sodium fluoride in a silica base and the other chamber contained dicalcium phosphate dihydrate (Test Dentifrice delivering 0.243% sodium fluoride), to a dentifrice containing 0.243% sodium fluoride in a silica base (Positive Control Dentifrice). MATERIALS AND METHODS: This study was conducted in harmony with the published 1988 American Dental Association guidelines for studies geared toward the comparison of fluoride dentifrices. This 2-yr caries clinical study employed a double-blind, parallel-group design, and involved 5-17 yr-old children from the Central and South areas of Florida and from the Lares area of Puerto Rico. Qualifying subjects were stratified according to age and sex, and were randomly assigned to the two treatment groups, with multiple subjects in the same household all assigned to the dentifrice randomly allocated to the first among them. Caries examinations were conducted in accordance with U.S. Food and Drug Administration guidelines for the clinical evaluation of drugs to prevent dental caries. Two calibrated examiners performed all the measurements. After treatment assignment, study participants were instructed to brush their teeth at home with their assigned dentifrice at least twice daily. Brushing instructions were reinforced by indoctrination in proper oral hygiene techniques by dental professionals, supplemented by pamphlets supplied by the sponsor and yearly mailings to participants, emphasizing good oral hygiene and the need to enforce compliance with the study. Post-baseline examinations were performed after 1 yr of product use, and again after 2 yrs of product use. RESULTS: Two thousand five hundred six (2,506) subjects completed this 2-yr study. For these subjects, the mean caries scores (DMFS, decayed, missing and filled tooth surfaces) at baseline were 2.29 for the Test Dentifrice group, and 2.47 for the Positive Control Dentifrice group. For caries increments after 1 yr, the respective means were 0.69 for the Test Dentifrice group and 0.81 for the Positive Control Dentifrice group. Finally, after 2 yrs, the mean caries increments were 1.25 for the Test Dentifrice group, and 1.46 for the Positive Control Dentifrice group. No statistically significant difference was indicated between the treatment groups at baseline or between the 1-yr caries increment scores. However, there was a statistically significant difference in the 2-yr caries increment scores between the treatment groups. Relative to the Positive Control Dentifrice group, the Test Dentifrice group presented a 14.38% reduction in caries increment scores at 2 yrs. In accordance with the procedures and standards provided by the published guidelines of the American Dental Association for the comparison of the anticaries efficacy of fluoride dentifrices, the results of this study support the conclusion that the dentifrice system in a dual-chambered tube, wherein one chamber contained sodium fluoride in a silica base and the other chamber contained dicalcium phosphate dihydrate, delivering 0.243% sodium fluoride, provided a superior level of anticaries efficacy than did the dentifrice containing 0.243% sodium fluoride in a silica base.