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ABSTRACT: Miranda J, Brunet Ll, Roset P, Farré M, Mendieta C. Reliability of two measurement indices for gingival enlargement. J Periodont Res 2012; 47: 776-782. © 2012 John Wiley & Sons A/S Background and Objective: The objective of this study was to analyze the concordance of the vertical gingival overgrowth index (GOi) and the horizontal Miranda & Brunet index (MBi) and to compare their reliability and reproducibility for an early diagnosis of gingival enlargement. A wide range of methods has been employed to determine the severity of drug-induced gingival enlargement (DIGE) that has resulted in uncertainty with regard to the prevalence of this side effect. In recent studies, different indices have been used to grade DIGE. The large variability observed between studies and the differences between vertical and horizontal gingival-enlargement measurements could be the result of the use of nonreliable indices during the measurement process. Some indices involve invasive procedures that require many measurements, or even a data-processing system, while others are less convenient and technically expensive and complex. In previous studies we used two complementary indices - the vertical GOi and the horizontal MBi. The results of these studies found some differences between both indices, with the MBi rendering higher estimates of DIGE prevalence that was attributed to its greater sensitivity for the detection of minimal changes in gingival thickness. To our knowledge, there are no studies comparing different measurement indices for gingival enlargement that are supported by statistical concordance analysis. Material and Methods: Twelve plaster casts from patients who had worn orthodontic brackets, and who had different degrees of chronic inflammatory gingival enlargement, were analyzed. Three previously trained examiners registered twice the degree of buccal overgrowth, using the GOi and MBi, in all cast models with a minimum interval of 7 d between the first and the second evaluation. In total, from each cast, measurements from 16 gingival sites were taken using the GOi, and from nine gingival units (mesial and distal sites measurements) using the MBi. Concordance analysis of the registered measurements (intra-examiner and among examiners) for each index and between indices was assessed using the nonweighted Kappa index with a confidence interval of 95%. Results: We obtained 648 values for the GOi and the MBi. The overall score 0 (indicating absence of enlargement) was 32.7% and 19.8% for GOi and MBi, respectively, score 1 (light/moderate) was 39.7% and 48.1%, and score 2 (severe) was 27.6% and 32.1%. Concordance analysis for each index showed intra-examiner Kappa values of 0.820 for the GOi and 0.830 for the MBi. Interexaminer Kappa values were 0.720 for the GOi and 0.770 for the MBi. Concordance between indices showed Kappa values for the same examiner of 0.600, whereas concordance among different examiners was 0.550. Discrepancies between indices indicated a systematic skew, with 79-82.1% of discrepancy associated with a higher value for the MBi compared with the GOi. Conclusion: Both gingival enlargement indices analyzed are reliable, complementary and applicable for measuring gingival overgrowth. However, the MBi shows, with fewer measurements, a greater sensitivity than the GOi for the detection of the early stages of gingival enlargement, being adequate for the screening of large populations at risk.
Journal of Periodontal Research 08/2012; 47(6):776-82. · 1.69 Impact Factor
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ABSTRACT: Predictors of gingival enlargement in patients treated with anti-epileptics have not been previously assessed. This study was conducted to determine, with the aid of two indices that score vertical and horizontal overgrowth, the prevalence and risk factors for gingival enlargement in patients treated with phenytoin and other anticonvulsant drugs.
A cross-sectional study was conducted and data from 59 patients taking antiepileptics were compared with 98 controls. Gingival enlargement was evaluated with two indices to score vertical overgrowth [Gingival overgrowth index (GO] and horizontal overgrowth [Miranda-Brunet index (MB)]. Gingival index, plaque index, and probing depth were also evaluated.
The prevalence of gingival enlargement was significantly higher (P < 0.0001) for both indices in the anticonvulsants treated groups than in the control group. Gingival overgrowth was significantly higher for both indices in the phenytoin group than in the non phenytoin group. Among the possible risk factors, only the gingival index showed a significant association with gingival enlargement. For the MB index the risk of gingival enlargement (odds ratio) associated to phenytoin therapy and other anticonvulsants therapy were 52.6 (13.5-205) and 6.6 (1.5-28.2). Gingival index-adjusted odds ratios for the same drugs were 5.7 (1.3-24.7) and 18.1 (2-158), respectively. The concordance between GO and MB indices in the control group and in the phenytoin-group and non phenytoin-group showed a Kappa value of 0.773 and 0.697, respectively.
This study reports significant differences in the prevalence and severity of gingival overgrowth in two groups of patients, one treated with phenytoin, and another treated with other anticonvulsants. Gingival inflammation is a significant risk factor for gingival enlargement in these patients.
European Journal of Clinical Investigation 09/2001; 31(9):781-8. · 3.02 Impact Factor
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ABSTRACT: Gingival enlargement is a known side effect of nifedipine use. This study was conducted to determine the prevalence and risk factors for gingival enlargement in nifedipine-treated patients.
A cross-sectional study was conducted in a primary care center. Data from 65 patients taking nifedipine were compared with 147 controls who had never received the drug. All patients were examined for the presence of gingival enlargement using 2 different indices: vertical gingival overgrowth index (GO) in 6 points around each tooth, and horizontal MB index in the interdental area. Gingival index, plaque index, and probing depth were also evaluated.
The prevalence of gingival enlargement was significantly higher in nifedipine-treated cases than in controls (GO index, 33.8% versus 4.1%; MB index, 50.8% versus 7.5%, respectively). Higher gingival and plaque indices were observed in patients taking nifedipine. Among the possible risk factors, only the gingival index showed a significant association with gingival enlargement. The risk (odds ratio [OR]) of gingival enlargement associated with nifedipine therapy was 10.6 (3.8-29.1) for the GO index and 14.4 (6-34.6) for the MB index. Gingival index-adjusted ORs were 9.6 (3.3-28.1) and 9.7 (3.9-23.3), respectively. In the subset of high nifedipine exposure patients, the odds ratio for gingival enlargement increased to 17.4 (5.3-56.3) for the GO index and 23.6 (7.7-72.3) for the MB index. The concordance between GO and MB indices showed a kappa value of 0.689 in controls and 0.642 in patients treated with nifedipine.
Patients taking nifedipine are at high risk for gingival enlargement, and gingivitis acts as a predisposing factor.
Journal of Periodontology 06/2001; 72(5):605-11. · 2.60 Impact Factor
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ABSTRACT: Community-based registries provide the best approach to assessing the impact of myocardial infarction (MI) in a population. The objective of the present study was to determine MI mortality, incidence, attack rate and 28-day case fatality in the province of Gerona, Spain from 1990 to 1992.
Standardized methods were used to find, register and classify MI cases in that population (509628 inhabitants) as definite, possible and insufficient-data MI.
Of the 1456 cases fulfilling eligibility criteria, 850 (58.4%) were classified as definite MI, 162 (11.1%) as fatal possible MI, 232 (15.9%) as no MI and 160 (11.0%) as fatal insufficient data. The 1990-1992 age-standardized incidence rates (first MI cases only) for definite and fatal possible MI were 140.8 per 100000 men and 20.4 per 100000 women, all aged 35-64 years; attack rates (first and recurrent MI cases) were 182.9 and 24.5, and mortality rates 46.4 and 5.8, respectively. Case fatality at 28 days was 27.4% and 19.9% in men and women, respectively, but women died later over that period. With respect to men, the age-adjusted risk among women of dying within 28 days post-MI was 1.26 (95% confidence interval [CI]: 0.94-1.69).
Myocardial infarction, incidence, mortality rates and case fatality in Gerona are among the lowest in the world. Age-adjusted case fatality within 28 days is only marginally higher in women than in men, but fatal cases occur later within this period in women.
International Journal of Epidemiology 09/1998; 27(4):599-604. · 6.41 Impact Factor
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ABSTRACT: The local and systemic tolerance of 7-chloro-3-[1-(2,4-dichlorophenyl)-2-(1H- imidazol-1-yl)ethoxy-methyl]benzo[b]thiophene (sertaconazole, FI-7045, CAS 99592-32-2) 2% cream was studied in healthy volunteers after cutaneous application in an increasing-dose schedule during 13 days. Blood and urine samples were collected after the application of 16 g of cream. Percentage of absorption was determined in eight 3 x 3 cm areas of the volar arm skin after 2 mg cream topical application. No changes on vital signs (blood pressure, heart rate and body temperature) or in the ECG were found during the trial. Sertaconazole did not produce skin irritation nor systemic side effects. Sertaconazole was not detected in either the serum and urine samples obtained. The percentage of cutaneous absorption at 24 h after administration reached 72% of the applied dose.
Arzneimittel-Forschung 06/1992; 42(5A):752-4. · 0.72 Impact Factor
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ABSTRACT: 7-Chloro-3-[1-(2,4-dichlorophenyl)-2-(1H-imidazol-1-yl)ethoxy-methyl] benzo[b]thiophene (sertaconazole, FI-7045, CAS 99592-32-2) is a new antimycotic which, in experimental infection studies, proved to possess potent antifungal activity. In a randomized, parallel, double-blind trial, the activity of sertaconazole cream was studied in 20 patients suffering from superficial mycoses caused by dermatophytes, confirmed by microscopic examination (KOH) and culture test. The patients, who were included in accordance with microbiological, microscopic and clinical criteria, were divided into two groups of 10 and were treated with sertaconazole 1% or sertaconazole 2% (cream) twice a day for 28 days. Both treatments achieved a total cure of the disease, with a cure being reached in a shorter time in the group of patients treated with sertaconazole 2%. No undesirable effects or statistically significant changes in the blood tests conducted at the end of the trial were observed. The results of the trial show that sertaconazole 2% cream is more effective. In view of the advantages offered by topical therapy over systemic therapy and of the good results obtained in patients with dermatophytosis, sertaconazole may represent an important advance in the therapy of superficial dermatophytoses.
Arzneimittel-Forschung 06/1992; 42(5A):760-3. · 0.72 Impact Factor
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ABSTRACT: The activity of 7-chloro-3-[1-(2,4-dichlorophenyl)-2-(1H-imidazol-1-yl) ethoxy-methyl]benzo[b]thiophene (sertaconazole, FI-7045, CAS 99592-32,2) was studied in a randomized parallel double-blind clinical trial on 21 patients suffering from Pityriasis versicolor (confirmed by KOH microscopic examination and exploration with Wood's light). The patients were divided into two treatment groups: one with 11 patients receiving sertaconazole 1% cream and the other with 10 patients receiving sertaconazole 2% cream. The cream was applied twice a day during 4 weeks. The data were assessed clinically and microscopically (optical and fluorescence). All the patients were cured (100% cure), showing excellent efficacy. A check-up performed after the end of the treatment showed no relapses of infection. The drug safety was optimum, since no local or general undesirable effects were recorded, nor were there any changes in the analytical parameters studied in the 21 patients. Because of its high antifungal activity and excellent safety, sertaconazole represents an important advance in the topical therapy of this disease.
Arzneimittel-Forschung 06/1992; 42(5A):764-7. · 0.72 Impact Factor
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ABSTRACT: The activity of 7-chloro-3-[1-(2,4-dichlorophenyl)-2-(1H-imidazol-1-yl)ethoxy-methyl] benzo[b]thiophene (sertaconazole, FI-7045, CAS 99592-32-2) was studied in a randomized parallel double-blind clinical trial on 20 patients suffering from superficial mycosis caused by Candida albicans (confirmed microscopically and microbiologically). The patients were divided into two groups; one received sertaconazole 1% cream (10 patients) and the other received sertaconazole 2% cream (10 patients), over a period of 28 days. Clinical, microscopic and microbiological parameters were evaluated. Analytical parameters such as the appearance of possible undesirable effects (both local and general) were also monitored. The cure was total for 19 out of the 20 patients, demonstrating high efficacy. There were no relapses of infection in any of the cured patients. No local or general effects were recorded during the trial. The analytical parameters remained within normal limits. The clinical and microbiological cure, absence of relapses and the non-existence of local and general undesirable effects indicate that sertaconazole may represent an important advance in the therapy of superficial mycosis caused by Candida albicans.
Arzneimittel-Forschung 06/1992; 42(5A):757-60. · 0.72 Impact Factor
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ABSTRACT: Background Community-based registries provide the best approach to assessing the impact of myocardial infarction (MI) in a population. The objective of the present study was to determiiie MI mortality, incidence, attack rate and 28-day case fatality in the province of Gerona, Spain from 1990 to 1992. Methods Standardized methods were used to find, register and classify MI cases in that population (509 628 inhabitants) as definite, possible and insufficient-data MI. Results Of the 1456 cases fulfilling eligibility criteria, 850 (58.4%) were classified as definite MI, 162 (11.1%) as fatal possible MI. 232 (15.9%) as no MI and 160 (11.0%) as fatal insufficient data. The 1990–1992 age-standardized incidence rates (first Mi cases only) for definite and fatal possible MI were 140.8 per 100 000 men and 20.4 per 100 000 women, all aged 35–64 years; attack rates (first and recurrent MI cases) were 182.9 and 24.5, and mortality rates 46.4 and 5.8, respectively. Case fatality at 28 days was 27.4% and 19.9% in men and women, respectively, but women died later over that period. With respect to men, the age-adjusted risk among women of dying within 28 days post-MI was 1.26 (95% confidence interval [CI] 0.94–1.69). Conclusions Myocardial infarction, incidence, mortality rates and case fatality in Gerona are among the lowest in the world. Age-adjusted case fatality within 28 days is only marginally higher in women than in men, but fatal cases occur later within this period in women.