Academic Clinical Trials Submitted to an Institutional Ethics Committee at a Tertiary Care Center: A Retrospective Analysis.

Background The role of academia in clinical research has given rise to the concept of academic clinical trials (ACTs), which are vital in generating evidence. Through the implementation of the New Drugs and Clinical Trials Rules-2019 (NDCTR-2019) rules, the Institutional Ethics Committee (IEC) has obtained a quasi-regulatory role. The study aims to assess the challenges the IEC faced when processing, approving, and monitoring ACTs. The other objectives included the number of ACTs submitted to the IEC, as well as administrative, scientific, and ethical issues stated by the IEC and the Drug Controller General of India (DCGI) authorities. We also aimed to provide some insight into the type of decision made by IEC and DCGI - the delay or inconsistency between the queries. Methods This retrospective study was conducted in the IEC of a tertiary care hospital, Mumbai, Maharashtra, India. A comprehensive search of the IEC database was carried out by the study team, and only those protocols of ACTs submitted to IEC between January 2015 and December 2021 were included. The studies submitted between January 2015 and February 2019, i.e., before the release of NDCTR-2019, were classified as the "Before" category. All subsequently submitted protocols were grouped together as the "After" group. Descriptive statistics were used to represent the data, while comparison between the two timeframes were made using the Mann-Whitney U test with a level of significance at 5%. Results This six-year study showed that merely 1.4% (34/2400) trials fulfilled the criteria of an ACT. An increase in the ACT protocol submission was noted in the "After" group (20 vs. 14). Most ACTs were drug trials, with 67.6% (23/34) trials conducted majorly in the Department of Anesthesiology. There was a statistical increase in time query reply by the principal investigator to IEC and the time between submission and approval in the "After" group (p<0.05). IEC sent out 94 administrative, 565 scientific, and 216 ethical queries. On IEC monitoring, protocol deviations were noted; nonetheless, no ACTs reported protocol deviations or serious adverse events. Conclusions Since the implementation of NDCTR-2019, IEC has taken on a quasi-regulatory function, and there has been an increase in the caliber of IEC monitoring and adherence to ethical norms.

Autonomy and factors affecting dental health care seeking behaviour in women: An application of theory of planned behaviour.

Background: Understanding oral health care seeking behaviour and it's determinants is essential in improving oral health. The health care utilization in women was found to be influenced by their autonomy. A socio-cognitive model that can explain variance in dental attendance behaviour in women including autonomy has yet to be validated. The Theory of Planned Behaviour (TPB), which takes into account women's autonomy, attitude, subjective norms, and perceived behavioural control, is empirically tested in this study with regard to self-reported dental visiting intentions and dental health seeking behaviour. Method: Cross sectional study using self-administered questionnaires was conducted to assess socio-demographic factors, autonomy, dental visiting behaviors as well as constructs of TPB model in 400 women aged 18 years or older in Bangalore city selected via stratified cluster sampling method. Two-stage structural equation modelling (SEM) was used to test the hypothesized TPB model. Results: The proposed correlated 5-factor measurement model was confirmed through confirmatory factor analysis (CFA). In SEM subjective norm (ß = 0.17), perceived behavioural control (ß = -0.27) and autonomy (ß = 0.49) significantly predicted dental visiting intentions in women. Intention (ß = 0.56) and autonomy (ß = 0.25) explained dental visiting behaviour. It also revealed indirect effect of autonomy and perceived behaviour control on dental visiting behaviour through intentions. The hypothesized model predicted 27.6 % and 23.8% of the variance in intention and dental visiting behaviour respectively. Conclusion: The hypothesized model was successful in predicting intention and dental visiting behaviour in women. This could explain the multidimensional nature of dental care utilization in women which in turn might be helpful in improving access to dental care among them in future.

Oral health status and parental perception of child oral health-related quality of life among children with cerebral palsy in Bangalore city: A cross-sectional study.

AIM: To assess and compare the oral health status and parental perception of child oral health-related quality of life (OHRQoL) among children with and without cerebral palsy (CP). METHODS AND RESULTS: A cross-sectional comparative study was conducted among 300 children aged 5-15 years with and without CP in Bangalore city. Oral health status was assessed using WHO 2013 criteria, and malocclusion was assessed using Angle's classification of malocclusion. Parental perception of child OHRQoL was assessed using parental caregivers perceptions questionnaire. Chi-square test, Student's t-tests and logistic regression were applied. Majority of the study participants were males with a mean age of 10 years. Caries experience, gingivitis, dental trauma, and dental erosion were significantly higher among children with CP than the comparison group. Mean parental perception of child OHRQoL score among CP was significantly higher than that of comparison group (P < .001). Odds of having caries experience, gingivitis, dental trauma, and Angle's Class II/III malocclusion were significantly higher among CP children with poor OHRQoL compared to those without these conditions. CONCLUSION: Oral health status among children with CP was poor than the children without CP. Parents perceived poor OHRQoL among children with CP when compared to those without CP. Hence CP has an impact on oral health necessitating preventive care.

Exploring educational and promotional opportunities for implementing oral rapid human immunodeficiency virus testing among dentists in India.

CONTEXT: Human immunodeficiency virus (HIV) is a public health problem in India. Dentist plays an important role in diagnosing since oral lesions are common in HIV-positive patients and have an ethical responsibility to provide treatment to them. AIMS: This study aims to explore educational and promotional opportunities for implementing oral rapid HIV testing (ORHT) among dentists in Bengaluru, India. SETTINGS AND DESIGN: A cross-sectional study was conducted among 300 dentists. Dentists were included from private practice, dental practice in general hospital, and dental teaching/hospitals. SUBJECTS AND METHODS: A 43-item questionnaire was used to assess demographics, educational knowledge on HIV and ORHT, attitude toward HIV patients, and willingness to promote ORHT and perceived barriers of performing ORHT. STATISTICAL ANALYSIS USED: The data were evaluated using SPSS 22. Student's t-test, Chi-square, Pearson correlation, and binary logistics were used keeping P value at 5%. RESULTS: Mean age of the participants was 38.97 ± 7.69 years with equal distribution of gender and practice. Majority were postgraduates (63.0%) and having general practice (56.6%). Although two-thirds of the participants belong to high score category, the mean knowledge level is below 50%. Mean score of knowledge was 10.70 ± 2.5. One hundred and thirty (43.3%) dentists were aware of ORHT, and 228 (76%) thought that ORHT was needed in the dental clinic. Dentist having specialty practice felt more accepting of ORHT (odds ratio = 2.455, 95% confidence interval 1.186-5.463). The lack of knowledge and training was the main barrier (39%) to conduct ORHT. CONCLUSIONS: The level of knowledge of the dentist about HIV/AIDS was acceptable. Majority of the dentist thought that ORHT is needed in a dental clinic. Overall, there was positive attitude toward HIV patients and ORHT.

Oral health status and parental perception of child oral health related quality-of-life of children with autism in Bangalore, India.

BACKGROUND: Children with autism present with the physical-mental impairments and oral problems, which may have an impact on their quality-of-life (QoL). The aim of the following study was to assess oral health status and parental perception of child oral health related quality of life (OHRQoL) among children with autism. MATERIALS AND METHODS: A cross-sectional study was conducted in 4-15-year-old children with autism (n = 135) and children without autism (n = 135). Oral health status was evaluated using Oral Hygiene Index-Simplified (OHI-S), its Miglani's modification for deciduous teeth, Decayed, missing and filled teeth (DMFT/dmft) and Decayed, missing and filled surface (DMFS/dmfs) indices. Parents answered the Parental-Caregivers Perception Questionnaire for assessing children's OHRQoL. Mann-Whitney U, Chi-square test and Pearson's correlation analysis were performed. RESULTS: Mean OHI-S, DMFT, dmft scores were significantly high among children with autism (2.07 ± 0.83; 0.86 ± 1.22, 1.40 ± 2.48) when compared to children without autism (0.46 ± 0.58; 0.46 ± 1.06, 0.59 ± 1.28) respectively. Out of all domains of OHRQoL, mean score of functional limitations related to teeth problem was significantly higher among children with autism (8.87 ± 5.65) as compared to non-autism group (6.66 ± 4.97). CONCLUSION: Functional limitations may have a negative impact on oral health status that might influence OHRQoL.

Prevalence of Various Orofacial Pain Symptoms and Their Overall Impact on Quality of Life in a Tertiary Care Hospital in India.

BACKGROUND: Pain is a major public health problem and is the most commonly reported symptom of oral and dental disease that has a significant impact on both individual and community. The present study was prevalence of various orofacial pain symptoms and their overall impact on the quality of life in a tertiary care hospital. MATERIALS AND METHODS: This study was carried out in the outpatient department of the Government Dental College and Research Institute, Bangalore. The severity of the chronic orofacial pain symptoms was assessed using the Chronic Pain Grade Questionnaire by Von Korff. RESULTS: The results showed that toothache (57.6 %) was the most commonly reported symptom and burning mouth sensation (6.4 %) was the least commonly reported. Majority of the patients had grade 3 level of pain-related disability (34.8 %) followed by grade 2 (26.8 %), grade 1 (22.4 %) and grade 4 levels (16 %). The mean pain intensity was reported to be more among females and maximum among patients with facial pain. CONCLUSION: The present study demonstrated that orofacial pain symptoms have a significant impact on the patients suffering from it. Therefore, proper measures should be taken for the management of the patients with these symptoms and associated conditions.