Unreported protocol deviations - The tip of the research-berg.

Introduction: Failure to stay within an ethics committee (EC)-approved protocol limits is termed protocol deviation or violation (PD/PV), depending on the seriousness of the transgression and its attendant risks and/or harms. PD/PVs arise in the post-approval phase of the research and are often missed. Current guidelines expect ECs to detect, report and recommend suitable actions such that research participants' risks and harms are mitigated, to the extent possible. Objective: Yenepoya Ethics Committee-1 conducted an internal audit of ongoing postgraduate dissertations involving human participants to assess the occurrence of PD/PVs. Materials and Methods: 54 out of 80 postgraduates responded to our request for filling out a self-reported checklist. These responses were followed up with physical verification of the protocol-related documents. Results: Protocol transgressions were classified as non-compliance (administrative issues), protocol deviations (minor transgressions with minimal or less than minimal increase in attendant risk to participants) and protocol violations (serious transgressions with more than minimal increase in attendant risk to participants). The non-compliances included non-reporting for audit and non-reporting of PDs. Protocol deviations included non-conformance to EC validity, sample size, approved methodology, informed consent process and documentation and suboptimal data storage. No protocol violations were observed. Conclusion: We report PD/PVs from these 54 protocols - with our assessment on the negative impact it may have on scientific validity, harm to participants, EC functioning and credibility of the institution - in the hope that our readers appreciate this important aspect of the post-approval process in the functioning of an EC.

Comparative Evaluation of Salivary Sialic Acid Levels Among Beedi Rollers and Tobacco Users in Mangalore, South India.

INTRODUCTION: According to World Health Organization, the global cancer burden is estimated to have risen to 18.1 million new cases and 9.6 million deaths in 2018. Tobacco use is a leading cause of cancer and of death from cancer. Beedis are the most popular smoking form of tobacco in India. Thirty-four percent of the tobacco produced in India is used for making beedis. The beedi sector is agroforestry-based and the second largest industry in India with approximately 4.4 million full-time beedi workers in India. Toxic constituents present in tobacco are released into the ambient air during the processing of beedis. METHODS: A descriptive cross-sectional study was conducted to assess and compare salivary sialic acid levels among beedi rollers, tobacco smokers, smokeless tobacco users and individuals with no tobacco exposure. The study sample comprised of 140 individuals who were 30 to 60 years old, who attended dental screening and treatment camps in rural and urban areas in Mangalore, conducted by the Department of Public Health Dentistry, Yenepoya Dental College and patients who visited the Department of Oral Medicine and Radiology of Yenepoya Dental College. Saliva was collected by passive drool method into a sterile container. Biochemical analysis of salivary sialic acid was done using the acidic ninhydrin method. Continuous variables are expressed in terms of mean and standard deviation. Categorical variables are expressed in terms of frequencies and percentages. To compare salivary sialic acid levels between the groups ANOVA was used. The Chi-square test was used to compare categorical variables between the groups. RESULTS: A total of 140 participants, 35 beedi rollers, 35 smokers, 35 smokeless tobacco users and 35 individuals with no tobacco exposure participated in the study. Among the 140 participants, 90 participants were males and 50 participants were females. There was a statistically significant difference in the mean salivary sialic acid level between the different groups (p<0.001) with smokeless tobacco users having the highest (10.60 mg/dL) mean salivary sialic acid level. It was found that the mean salivary sialic acid level reduced as the age progressed, even though there was no statistically significant difference. There was a statistically significant difference in the mean salivary sialic acid level between the different groups (p=0.010) with participants with 11 to 20 years of exposure to tobacco having the highest (8.67 mg/dL) mean salivary sialic acid level and participants with no tobacco exposure having least (3.06 mg/dL) mean salivary sialic acid level. CONCLUSION: The salivary sialic acid level was more in beedi rollers than individuals with no tobacco exposure, even though the difference was not statistically significant. The results showed elevated levels of salivary sialic acid in smokeless tobacco users followed by tobacco smokers. This may be an indication that smokeless tobacco use has harmful effects similar to or more than tobacco smoking since salivary sialic acid levels in smokeless tobacco users were higher than those in smokers.

Evaluation of Salivary Parameters and Oral Health Status Among Asthmatic and Nonasthmatic Adult Patients Visiting a Tertiary Care Hospital.

INTRODUCTION: Asthma is a chronic inflammatory disorder of the airways characterized by attacks of bronchoconstriction causing shortness of breath, coughing, and rapid breathing. Patients undergoing inhalation therapy are subjected to a higher risk of dental caries due to the reduced saliva secretion, decreased pH value, increased number of cariogenic bacteria caused by inappropriate oral hygiene, and the use of inhaling medicaments with dry powder. METHODS: The descriptive study was carried out among 200 patients aged (18-45 years) visiting Yenepoya Hospital, Mangalore during the period from May 2018 to October 2018 to evaluate salivary parameters and oral health status in asthmatic and nonasthmatic patients. Data were collected using WHO criteria (2013) and samples of unstimulated saliva were collected for evaluation of salivary flow rate, pH, buffering capacity, and calcium. Statistical analysis was done using SPSS version 21.0 software with the level of significance set at p < 0.05.  Results: A decreased mean score of salivary flow rate, pH, and buffering capacity were found in asthmatic patients compared to nonasthmatic patients (p < 0.001). A higher mean decayed, missing, and filled teeth (DMFT) score and an increased dental erosion score were found in asthmatics compared to nonasthmatics (p < 0.05). Asthmatics had higher gingival bleeding score than nonasthmatics. CONCLUSION:  In order to prevent disease progression in the hard dental tissue and oral cavity of asthmatic patients, it is necessary to apply adequate preventive measures and motivate their continuous application in this caries-risk population.

Effect of Paneer and Cheese Consumption on Salivary Acidogenicity and Calcium Concentration: A Comparative Study.

PURPOSE: To assess and compare the salivary pH reversal phenomenon and calcium concentration in subjects consuming paneer and cheese after an acidogenic challenge and also to compare the salivary pH measurements using pH strips and a portable pen-type pH meter. MATERIAL AND METHODS: Sixty caries free undergraduate students were randomly selected and divided into two group: 1. paneer; 2. cheese. After determining the resting salivary pH using pH strips and a pen-type pH meter, participants were subjected to an acidogenic challenge (10% sucrose). Following consumption of test foods (10-gram cubes), salivary pH was measured at intervals of 5, 10, 15, 30 and 60 min to record the time taken for the salivary pH to return to baseline. Colorimetric salivary calcium concentration was estimated (Biochemical Analyzer) at baseline and after 60 min of test food consumption. The statistical tests used were Shapiro-Wilk's test for normality, repeated measures ANOVA, and the independent t-test. RESULTS: Test meals reversed the fall in pH after acidogenic challenge starting at 5 min and returning to baseline values after 30 min in both groups (p = 1.000). Colorimetric estimates showed higher salivary calcium concentrations with paneer (p < 0.001). The pen-type pH meter showed superior efficiency in terms of time (p < 0.001) compared to pH strips. CONCLUSION: The salivary pH reversal phenomenon was evident after consumption of both paneer and cheese following the acidogenic challenge. Consumption of paneer significantly increased salivary calcium concentration. The pen-type pH meter proved to be more efficient.

Correlation of CD4 count with cariogenic oral flora indicators and dental caries in HIV-seropositive children undergoing antiretroviral therapy in Mangaluru, South India.

AIM: The aim of the present study was to compare the association of CD4 count with cariogenic oral flora indicators and dental caries in HIV-seropositive children receiving antiretroviral therapy (ART). METHODS: A descriptive study was conducted among HIV-seropositive children receiving ART at Snehasadan Camillian Care and Support Center HIV/AIDS in Mangaluru, India. Demographic details and r recent CD4 counts were recorded. For dental caries, the Decayed, Missing, Filled Teeth (DMFT)/decayed, missing, filled/decayed, extracted, filled index was used. Data were analyzed using SPSS version 22. Spearman's correlation was used to correlate CD4 count with dental caries and cariogenic oral flora indicators (mutans streptococci and lactobacilli). RESULTS: The study population comprised 35 patients. Dental caries prevalence was 54.1% in deciduous teeth and 41.2% in permanent teeth. Age and DMFT showed a significant, positive correlation; age and dmft showed a negative correlation (P < .05). A weak, negative correlation was found between age and Streptococcus mutans (S. mutans), and also CD4 count; S. mutans and CD4 count and dmft were not found to be statistically significant (P < .05). CONCLUSION: No statistically-significant correlation was found between CD4 count and cariogenic oral flora indicators in HIV-positive patients. The presence of a minimum number of restored teeth compared to decayed teeth suggests a lack of dental care being given to HIV-positive patients.

Changes in the Oral Environment after Placement of Fixed Orthodontic Appliance for the Treatment of Malocclusion - a Descriptive Longitudinal Study.

PURPOSE: The aim of this study was to determine the changes of salivary flow rate, pH, buffering capacity, total antioxidant capacity and changes in streptococci and lactobacilli counts at baseline, 1 month and 6 months of fixed orthodontic treatment. MATERIALS AND METHODS: An unstimulated salivary sample was collected from 30 out of 43 patients who were in need of fixed orthodontic treatment (mean age 17.8 ± 5.01 years). Salivary samples were collected from the patients before the placement of fixed orthodontic appliance (Gemini MBT 0223M) at 1 month and 6 months following start of the treatment. Samples were tested for significant changes in flow rate, pH, buffering capacity, total antioxidant capacity and streptococci and lactobacilli counts. Results were compared using ANOVA. RESULTS: The study results showed that orthodontic appliances significantly changed the unstimulated salivary flow rate (p < 0.05) (baseline: 0.40 ± 0.11, 1 month: 0.45 ± 0.09, 6 months: 0.44 ± 0.07) and buffering capacity (p < 0.05) (baseline: 5.01 ± 0.50,1 month: 3 .98 ± 0.78, 6 months: 4.02 ± 0.78) at the end of 1 month and 6 months whereas lactobacilli count showed significant changes at the end of 6 months (p < 0.05) (baseline: 6.20 ± 2.07, 1 month: 7.09 ± 3.78, 6 months: 7.85 ± 1.88). The pH, total antioxidant capacity and streptococci counts did not show any significant changes during the study period. CONCLUSION: It appears that 6 months of treatment with fixed orthodontic appliance resulted in a significant increase in unstimulated salivary flow rate and lactobacilli counts, whereas buffering capacity decreased significantly during the study period.

Knowledge, attitude and anxiety pertaining to basic life support and medical emergencies among dental interns in Mangalore City, India.

BACKGROUND: This cross-sectional study aimed to assess the knowledge, attitude and anxiety pertaining to basic life support (BLS) and medical emergencies among interns in dental colleges of Mangalore city, Karnataka, India. METHODS: The study subjects comprised of interns who volunteered from the four dental colleges. The knowledge and attitude of interns were assessed using a 30-item questionnaire prepared based on the Basic Life Support Manual from American Heart Association and the anxiety of interns pertaining to BLS and medical emergencies were assessed using a State-Trait Anxiety Inventory (STAI) Questionnaire. Chi-square test was performed on SPSS 21.0 (IBM Statistics, 2012) to determine statistically significant differences (P<0.05) between assessed knowledge and anxiety. RESULTS: Out of 183 interns, 39.89% had below average knowledge. A total of 123 (67.21%) reported unavailability of professional training. The majority (180, 98.36%) felt the urgent need of training in basic life support procedures. Assessment of stress showed a total of 27.1% participants to be above high-stress level. Comparison of assessed knowledge and stress was found to be insignificant (P=0.983). CONCLUSION: There was an evident lack of knowledge pertaining to the management of medical emergencies among the interns. As oral health care providers moving out to the society, a focus should be placed on the training of dental interns with respect to Basic Life Support procedures.

Effect of Herbal and Fluoride Mouth Rinses on Streptococcus mutans and Dental Caries among 12-15-Year-Old School Children: A Randomized Controlled Trial.

To assess and compare the effect of herbal and fluoride mouth rinses on Streptococcus mutans count and glucan synthesis by Streptococcus mutans and dental caries, a parallel group placebo controlled randomized trial was conducted among 240 schoolchildren (12-15 years old). Participants were randomly divided and allocated into Group I (0.2% fluoride group), Group II (herbal group), and Group III (placebo group). All received 10 ml of respective mouth rinses every fortnight for a period of one year. Intergroup and intragroup comparison were done for Streptococcus mutans count and glucan synthesis by Streptococcus mutans and dental caries. Streptococcus mutans count showed a statistically significant difference between Group I and Group III (p = 0.035) and also between Group II and Group III (p = 0.039). Glucan concentration levels showed a statistically significant difference (p = 0.024) between Group II and Group III at 12th month. Mean DMF scores showed no statistical difference between the three groups (p = 0.139). No difference in the level of significance was seen in the intention-to-treat and per-protocol analysis. The present study showed that both herbal and fluoride mouth rinses, when used fortnightly, were equally effective and could be recommended for use in school-based health education program to control dental caries. Trial registration number is CTRI/2015/08/006070.

Knowledge,attitude and anxiety pertaining to basic life support and medical emergencies among dental interns in Mangalore City,India / 世界急诊医学杂志（英文）

BACKGROUND:This cross-sectional study aimed to assess the knowledge, attitude and anxiety pertaining to basic life support (BLS) and medical emergencies among interns in dental colleges of Mangalore city, Karnataka, India. METHODS:The study subjects comprised of interns who volunteered from the four dental col eges. The knowledge and attitude of interns were assessed using a 30-item questionnaire prepared based on the Basic Life Support Manual from American Heart Association and the anxiety of interns pertaining to BLS and medical emergencies were assessed using a State-Trait Anxiety Inventory (STAI) Questionnaire. Chi-square test was performed on SPSS 21.0 (IBM Statistics, 2012) to determine statistical y significant differences (P<0.05) between assessed knowledge and anxiety. RESULTS:Out of 183 interns, 39.89％ had below average knowledge. A total of 123 (67.21％) reported unavailability of professional training. The majority (180, 98.36％) felt the urgent need of training in basic life support procedures. Assessment of stress showed a total of 27.1％ participants to be above high-stress level. Comparison of assessed knowledge and stress was found to be insignificant (P=0.983). CONCLUSION:There was an evident lack of knowledge pertaining to the management of medical emergencies among the interns. As oral health care providers moving out to the society, a focus should be placed on the training of dental interns with respect to Basic Life Support procedures.