Heterogeneity of outcome measures in the clinical trials of treatment for oral submucous fibrosis-Systematic review.

OBJECTIVE: This systematic review was performed to evaluate the range of outcome measures used in interventional trials for oral submucous fibrosis (OSF). MATERIALS AND METHODS: PubMed, Scopus, and Cochrane databases were searched to identify randomized controlled trials (RCTs) published from 2004 to 2018 about OSF treatment. All the outcome measures and measurement methods mentioned in the trials were extracted and analyzed. RESULTS: Out of 120 published papers, 12 RCTs that met the inclusion criteria were included. A total of 38 single outcome measures and 29 composite outcome measures were considered under four different outcome domains, of which clinical symptoms and clinical response were the most commonly used. The linear measurement of mouth opening (11 trials; 91.66%) and Visual Analogue Scale (10 trials, 83.33%) were the predominant measurement methods. CONCLUSIONS: This systematic review highlights the high heterogeneity in outcome measures in therapeutic RCTs of OSF. This lack of widely agreed standard outcome measures in OSF is a great concern as it prevents the comparison of studies and meta-analyses to gather evidence. There is a dire need of establishing a core outcome set for reporting in the future clinical trials that may help facilitate treatment choice for OSF to improve life quality of patients.

Malignant transformation in oral submucous fibrosis: Tertiary level evidence: An umbrella review.

OBJECTIVES: An umbrella review is a systematic review of systematic reviews, which provides a tertiary level of evidence. This umbrella review of systematic reviews and meta-analysis (SR-MA) aimed to determine the proportion of oral cancer (OC) development in oral submucous fibrosis (OSF) patients. MATERIALS AND METHODS: We searched electronic databases including PubMed, Scopus, Web of Science, Cochrane and grey literature. Two reviewers independently screened abstracts and assessed for eligible papers. The methodological quality of SR-MA was evaluated using AMSTAR2, and we also checked the quality of evidence of the included papers. RESULTS: Out of 454 papers identified in the primary search, 105 underwent eligibility screening. Inclusion criteria were met by four SR-MA. OC ratios ranged between 4.2% and 6% for OSF. Substantial heterogeneity was observed for this outcome in all four MA (I2 = 71.31% to 86.37%). None of the SRs assessed the quality of evidence, and half of them were judged to be of critically low methodological quality. CONCLUSION: There is lack of quality of evidences and critically low methodological quality among SRs and MA leading to substantial heterogeneity. However, due to potentially malignant nature, OSF patients should be monitored carefully for early detection of OC.

Impact of socioeconomic inequalities on quality of life in oral submucous fibrosis patients.

AIM: The purpose of this study was to analyze the impact of socioeconomic characteristics on oral health-related quality of life (OHRQoL) in patients with oral submucous fibrosis (OSF). METHODS:  A total of 300 OSF patients' quality of life (QoL) data were obtained using OHRQoL-OSF and global self ratings of oral health and overall wellbeing. The socioeconomic status (SES) of participants was analyzed by using modified Kuppuswamy scale. RESULTS: OSF patients with lower SES had worse OHRQoL as compared with those with middle and upper SES (p < 0.001). The household income of the family was found to be strongly associated with poor OHRQoL. CONCLUSION: Socioeconomic characteristics should be considered in the holistic management of OSF as it has been strongly associated with the OHRQoL of these patients.

Comparison of generic and condition-specific oral health-related quality of life instruments in patients with oral submucous fibrosis.

PURPOSE: With the growing interest in health economics, there is a demand for best valid instrument to assess quality of life (QoL) in patients with oral submucous fibrosis (OSF). The objective of this study was to compare the convergent and discriminative properties of the condition-specific OHRQoL-OSF and generic OHIP-14 in OSF patients. METHODS: The OHRQoL-OSF and OHIP-14 instruments were administered concurrently to 300 clinically diagnosed OSF patients. Analysis of both the instruments was carried out by using descriptive statistics. The internal consistency and reproducibility of the instruments were assessed using Cronbach's alpha and intra-class correlation coefficient respectively. The convergent and discriminative validity were then determined and compared. RESULTS: The OHRQoL-OSF and OHIP-14 exhibited good psychometric properties for internal consistency (Cronbach's alpha > 0.88) and reproducibility (ICC > 0.85). A positive associations were observed between both the instruments, but a high prevalence of patients with no impact was noted using the OHIP-14. Both the instruments were able to discriminate between patients with different clinical stages of OSF, but OHRQoL-OSF was more responsive in the early stages of OSF. The OHRQoL-OSF demonstrated greater sensitivity for 'discomfort and functional impairment'. CONCLUSIONS: The condition-specific OHRQoL-OSF identified OSF patients with impaired oral health-related QoL more easily with greater discriminative properties. To better understand patient reported experiences in OSF, these results may guide the choice of instrument in future researches and surveys.

Similarity Index Analysis of the Manuscript: A Viewpoint.

Fabrication, falsification, and plagiarism have been considered the major academic/scientific misconduct in writing the research.1 In recent decades, plagiarism detection has become relatively easy with the evolution of newer software.2,3 Undoubtedly, many scientific journals evaluate the received manuscripts for plagiarism/similarity index and strictly refuse to consider manuscripts with higher similarity index for further publication process. In addition, if plagiarism is reported in the published articles, authors may pose various academic, professional, and legal consequences. This is definitely fruitful in producing originality of the articles with newer ideas/concepts in research design.

Bibliometric analysis of 100 most cited articles on oral submucous fibrosis.

BACKGROUND: Citation analysis reflects the scientific recognition and influential performance of an article in the scientific community. The objective of this study was to identify and characterize the 100 most cited articles on oral submucous fibrosis (OSF). METHODS: A list of 100 most cited articles related to OSF was retrieved from the Science Citation Index-Expanded tool of Scopus database in May 2018. The articles were further reviewed, and basic information was recorded including the number of citations, citation density, journals, with its impact factor, category and quartile, publication year, authors, institution and country of origin, article type and level of evidence. Descriptive statistics were used to summarize the results. RESULTS: The most frequently cited article received 780 citations, while the least frequently cited article received 49 (mean 107.5 citations per article). There were 38 different journals with Journal of Oral Pathology and Medicine having the most citations (n = 22). The 100 most cited articles were published from 1966 to 2013, with 81% published after 1990. Thirteen authors listed 5 or more articles in the top 100 list, and India was found to be the most prolific country with 38 articles. In terms of article type, there were 72 research articles and 28 review articles. CONCLUSIONS: This first citation analysis of the 100 most cited articles renders a historical perspective on the progress of research in the field of OSF and enables the comprehensive identification and recognition of the most important and relevant research topics concerned.

Impact of oral potentially malignant disorders on quality of life: a systematic review.

Although oral potentially malignant disorders (OPMDs) are relatively common and potentially debilitating, literature on quality of life (QoL) in these patients is scanty. The purpose of this paper is to systematically review the literature on QoL in patients with OPMDs. A total of 210 titles were retrieved from electronic and manual databases searched from 1960 until September 2017. Out of these, 25 met our strict inclusion criteria as per the preferred reporting items for systematic reviews and meta-analyses guidelines. Most studies have assessed QoL in patients with oral lichen planus, reports of which cannot be generalized to all patients with OPMD. The findings of the studies differ but, overall, do not provide evidence that OPMD patients have a poorer QoL than healthy subjects.

Impact of oral submucous fibrosis on oral health-related quality of life: A condition-specific OHRQoL-OSF instrument analysis.

OBJECTIVE: Oral submucous fibrosis (OSF) could have a significant impact on daily life activities of affected individuals. The objective of this study was to investigate the impacts of OSF on oral health-related quality of life (OHRQoL). MATERIALS AND METHODS: A total of 206 clinically diagnosed OSF patients were recruited and subjected to the condition-specific OHRQoL-OSF instrument and global self-ratings of oral health and overall well-being. RESULTS: "Discomfort and functional impairment" dimension was highly prevalent among patients with all stages (p < 0.001). OSF also has impacts on other domains, namely "psychological wellness" (82.35%) and "social wellness" (61.16%). Stage IV OSF (25.94 ± 4.05) patients reported higher OHRQoL-OSF scores as compared to stage III (16.20 ± 2.58) and stage II OSF (7.26 ± 1.70) patients. However, stage I OSF patients reported significantly better OHRQoL (p < 0.001). A significant trend demonstrating overall OHRQoL-OSF scores increasing with advancing stages of OSF was observed. The majority of the participants rated their overall oral health status "fair" (34.95%) to "very poor" (26.21%), whereas overall well-being was rated as moderate (33.00%) to good (31.55%). CONCLUSION: OSF has a significant impact on OHRQoL. Increasing severity of OSF is associated with the worsening QoL.

"Mind" in Betel-quid Use and Related Disorders.

Oral squamous cell carcinoma is characterized by a unique predisposing state called oral potentially malignant disorders (OPMDs). Wide variety of carcinogenic insult in the form of detrimental habits can contribute to the causation of variety of OPMDs.1,2.

Quality of Life-related "Patient-reported Outcome Measures" in Oral Submucous Fibrosis Patients.

AIM: The aim of this study was to explore the patients' perspectives about the impact of oral submucous fibrosis (OSF) on life quality. MATERIALS AND METHODS: Thirty clinically diagnosed OSF patients with a wide degree of disease severity and diverse range of sociodemographic profile were included in this study. Fourteen participants were interviewed and four focus group discussions were conducted in nonclinical settings. The audio recordings were anonymized, transcribed, and translated in English from Marathi language. Data were analyzed using an in-depth narrative thematic analysis method. RESULTS: Four main themes evolved from the interviews: (1) discomfort and functional impairment; (2) psychological wellness; (3) physical wellness, and (4) social wellness. Majority of the participants discussed about discomfort and functional impairment. Participants also reported greater impact of OSF on psychological and social wellness. CONCLUSION: This study demonstrated the impact of OSF on different aspects of participant's life. "Discomfort and functional impairment" was noticed to be the most recognized theme by our participants. However, OSF also has impacts on other important domains, namely psychological, social, and physical wellness. CLINICAL SIGNIFICANCE: The patient-reported outcome (PRO) measure (PROM) reflects an integral aspect of general health and well-being and thus can be used to elucidate the impact of OSF on the quality of life (QoL) of affected individuals. These patients' perspectives should be taken into consideration along with thorough clinical examination to decide and effectively manage the overall health care needs of the OSF patients.

Analyses of the Erosive Potential of Various Soft Drinks and Packaged Fruit Juices on Teeth.

AIM: This study aimed to evaluate the erosive potential of twenty beverages (8 carbonated drinks and 12 packaged fruit juices). MATERIALS AND METHODS: Twenty-one sound permanent freshly extracted teeth were segmented into small enamel slices and stored in normal saline. The titratable acidity of each experimental drink was measured as the amount of 0.1 N sodium hydroxide (NaOH) required to raise pH to 5.5 and 7. The enamel specimens were incubated in freshly collected human saliva for 3 hours. One enamel slice was immersed in each beverage and percentage weight loss in the enamel slice was calculated after 6 and 24 hours intervals. RESULTS: The titratable acidity values of the experimental drinks ranged from 0.2 to 5.6. The mean titratable acidity values of the packaged fruit juices were higher than carbonated drinks. A significant difference (p < 0.0 5) was found in the percentage weight loss of enamel specimens after 6 and 24 hours immersion in the carbonated drinks than packaged fruit juices. Apple juice followed by thumps up were found to be the most erosive drinks with the least effects of Miranda and Guava juice. CONCLUSION: Most of the beverages tested in this study showed erosive potential. The carbonated drinks caused significant dental erosion. CLINICAL SIGNIFICANCE: Individuals at risk for beverages-associated erosion, particularly those with high intakes or decreased salivary flow, should be provided preventive guidance regarding habits of beverages intake. Specific dietary recommendations for the prevention of dental erosion may now be developed based on the patient's history of beverage consumption.

Oral Manifestations in Diabetic and Nondiabetic Chronic Renal Failure Patients receiving Hemodialysis.

Aim: To assess the prevalence of oral findings in diabetic and nondiabetic chronic renal failure (CRF) patients receiving hemodialysis (HD). Materials and methods: This study was conducted on 144 CRF patients undergoing HD therapy. They were further classified into diabetic and nondiabetic groups and also according to the duration of CRF. An oral examination was performed, searching for CRF-associated oral findings, along with due considerations to duration of CRF. Results: The oral manifestations were found to be higher in diabetic CRF patients (97.14%) relative to nondiabetic CRF patients (89.18%). The diabetic group exhibited a significantly higher number of patients with poor oral hygiene index (p = 000), uremic fetor (p = 0.005), unpleasant taste (p = 0.009), dry-fissured lips (p = 0.002), and pale mucosa (p = 0.019) than the nondiabetic group. The oral manifestations were significantly higher in CRF patients of more than 24 months' duration. Conclusion: The CRF HD patients with diabetes mellitus exhibited a higher risk of oral uremic manifestations including uremic fetor, unpleasant taste, pale mucosa, and dry-fissured lips than nondiabetics. The oral health status of CRF HD patients becomes worse with the increase in the duration of CRF. Clinical significance: Oral health status is often a neglected aspect in CRF patients. It should be given prime importance for CRF patients receiving HD to improve the quality of life. Keywords: Chronic renal failure, Diabetes, Hemodialysis, Oral manifestations.

Quality of Life Assessment should be Part of Oral Health Evaluations in Day-to-day Practice.

According to the World Health Organization (WHO), "Health is a state of complete physical, mental, and social wellbeing and not merely the absence of disease and infirmity."1 Quality of Life (QoL) is a crucial and often required measure of an individual's general well-being. The QoL is an established term incorporating different facets of life like physical, psychological, social, economical, spiritual, cognitional, and sexual dimensions.

Clinico-pathological and prognostic overview of metastasizing ameloblastoma: An overview of the systematic reviews.

Background: Metastasizing Ameloblastoma (MA) is an aggressive variant of ameloblastoma (AM) with the ability to metastasize without cytological malignant changes. Thus it aims to comprehensively review the clinico-pathological and prognostic aspects of MA through integration of current literature. Methods: Electronic searches were conducted in PubMed-MEDLINE, Scopus, Web of Science and Google Scholar. Two independent reviewers screened abstracts and evaluated paper eligibility. AMSTAR2 checklist was used to assessed methodological quality of included systematic reviews (SRs). Results: From 390 initial papers, 279 underwent eligibility screening, with five systematic reviews (SRs) meeting inclusion criteria. Six hundred sixty-one MA cases were found in five SRs that were included. MA predominantly affects men, exhibits mandible preference, and occurs in individuals in their fourth or fifth decade. Benign metastatic deposits commonly manifest in lungs and lymph nodes. Distant metastasis probability rises with multiple recurrences and incomplete surgical removal. Tumor recurrence and metastasis unfavorably impact clinical outcomes. Quality of evidence assessment was absent across SRs; four SRs were critically low in methodological quality. Conclusions: AM's metastatic potential lacks predictability. Early/multiple recurrences post-treatment may signal poor prognosis, warranting vigilant follow-up. Methodical analysis of each AM case is imperative to comprehend the metastatic-benign histology relationship.

Evaluation of serum vitamin B12 levels and its correlation with clinical presentation in patients with trigeminal neuralgia.

Background: The objective of this study was to estimate serum vitamin B12 levels and its correlation with severity of clinical presentation in patients with trigeminal neuralgia (TN). Methods: A total of 80 participants were included and rendered into study group: 40 TN patients and control group: 40 healthy individuals. The serum vitamin B12 estimation of each participant was carried out by using serum vitamin B12 ELISA kit and pain characteristics of TN patients were recorded in details. Results: The mean serum vitamin B12 level was noticed to be significantly lower (p = 0.042) in study group (296.87 ± 248.75 pg/mol) as compared to control group (423.5 ± 296.41 pg/mol). There was a statistically significant difference in serum vitamin B12 level between vegetarian TN patients and those who were on mixed diet (p = 0.001). The pain associated with TN predominantly reported unilaterally involving the right side (55%), female gender (55%) and mandibular division (50%). Although pain intensity showed no significant relation (p = 0.024), duration of pain reported a strong negative association with mean serum vitamin B12 levels in TN patients (p = 0.001). Conclusions: Vitamin B12 supplements can be added to the established treatment protocol for the holistic management of TN patients particularly those who are on vegetarian diet.

Ki-67, CD105, and α-smooth muscle actin expression in oral squamous cell carcinoma corresponds with different forms of tobacco consumption habits.

Background: Association with variety of etiological agents is one of the characteristic features of oral squamous cell carcinoma (OSCC). We hypothesized the existence of tobacco consumption habit-based heterogeneity in the immunohistochemical expression of carcinogenesis relevant molecular markers in OSCC. Hence, the present study was conducted to investigate the carcinogenesis relevant three commonly expressed markers (Ki-67, CD105, and α-smooth muscle acting [SMA]) in various forms of tobacco consumption habits in OSCC patients. Materials and Methods: A total of 217 patients of OSCC were included in the study, and based on the habit, they were broadly categorized into tobacco lime (TL), TL and areca nut (TLAN), and areca nut (AN). Further, categorization was done on the basis of absence or presence of additional habit of smoking. Immunohistochemistry (IHC) was performed using Ki-67, CD105, and α-SMA markers on formalin-fixed paraffin-embedded tissues. Results: TLAN (62.21%) was the most common habit noted in OSCC patient followed by TL (20.73%) and AN (15.20%). The additional habit of smoking was observed in 31.11% and 25.92% of TL and TLAN habits of OSCC patients, respectively. All the three markers (Ki-67, CD105, and α-SMA) showed statistically significant differences in the habit group such as TL, TLAN, and AN (P < 0.001). Although the expression of all the three markers was increased in TL as compared with TLAN, differences were not statistically significant. When these markers were compared in with and without smoking category, only TLAN with smoking and TLAN without smoking showed statistically significant differences in the expression of all three markers. Conclusions: Ki-67 CD105 and α-SMA immunohistochemical expression in OSCC corresponds with different forms of tobacco consumption habits. Habit-related unique carcinogenesis events are reflected at IHC level thus providing proof of concept for future studies.

Ki67 Labelling Index predicts clinical outcome and survival in oral squamous cell carcinoma.

OBJECTIVE: To investigate the Ki 67 expression and its correlation with clinicopathological features and 3 years as well as 5 years survival rate in oral squamous cell carcinoma (OSCC). METHODOLOGY: Total 217cases of OSCC primarily treated with surgery with or without radiation were included. All patients were followed up for 3 years and 150 were followed up of 5 years for disease free survival. The immunohistochemistry was carried out on neutral buffered formalin fixed paraffin embedded tissue to evaluate the expression of Ki67. RESULTS: The Ki67 labeling index (LI) was significantly higher with respect to adverse clinicopathological parameters such as histopathological grading (p<0.001), clinical TNM staging (p<0.001) and nodal metastasis (p<0.001). The OSCC patients survived for less than 3 and 5 years were showed significantly higher Ki67 LI as compared to diseases free survived more than 3 and 5 years(p<0.001). The three years survival rate of OSCC patient significantly higher with low Ki67 LI (≤45) 96.2%, followed by moderate Ki67 LI (46 to 60) 60.7% and high Ki67 LI (≥61) 37.7% (p<0.001). The five years survival rate of OSCC patient statistically significantly higher with low Ki67 LI (≤45)93.3%, followed by moderate Ki67 LI (46 to 60) 46.8% and Ki67 LI (≥61) 23.3% (p<0.001). CONCLUSION: The measurement of cell proliferative activity by using Ki67 antigen expression in individual OSCC might provide unique, predictive information on clinical outcome, prognosis and deciding treatment modalities in OSCC.

Oral and general health-related quality of life in oral squamous cell carcinoma patients- comparative analysis of different treatment regims.

BACKGROUND: Modern aggressive oncological treatment options for oral squamous cell carcinoma (OSCC) are inevitably associated with impaired general health-related quality of life (HRQoL) and oral HRQoL (OHRQoL). However, there is dire need for prospective and concomitant assessment of HRQoL and OHRQoL after different treatment regims. Hence, present study was designed to investigate HRQoL and OHRQoL in patients treated for OSCC using various modalities. METHODS: 135 OSCC patients were grouped according to treatment rendered into Group A: surgery only; Group B: post-surgical radiotherapy (PRT); and Group C: post-surgical chemo-radiation (PCRT). The 12-item Short Form Health Survey (SF-12) and Oral Health Impact Profile-14 (OHIP-14) were intervened to assess HRQoL and OHRQoL respectively at 1-month and 6-months post-treatment. RESULTS: At 1-month post-treatment, patients who received PCRT showed significantly lower mean values for physical and mental domains of SF-12 and higher mean subscales and overall OHIP-14 (24.57 â€‹± â€‹2.62) score than those treated by surgery alone (10.55 â€‹± â€‹2.26) and PRT (20.20 â€‹± â€‹3.80), with largest differences between PCRT and surgery alone groups (p â€‹< â€‹0.001). Social functioning, general health and bodily pain of SF-12 and functional limitations, physical pain and physical disability amongst OHIP-14 domains were greatly affected. Although few physical domains of SF-12 showed significant improvement, mental domains remained a greater problem after 6 months. However, OHRQoL was significantly poor in all the three study groups (p â€‹< â€‹0.001). CONCLUSION: Irrespective of the post-treatment duration, patients who received PCRT had worse HRQoL and OHRQoL. There is a need to identify factors associated with impaired HRQoL and OHRQoL to customize better therapeutic decisions.

Prevalence of Trismus and Its Impact on Oral Health-Related Quality of Life in Patients Treated for Oral Squamous Cell Carcinoma.

Oral squamous cell carcinoma, one of the most common malignancies, has a poor prognosis due to impairment in oral functions secondary to treatment. Trismus one of the major causes of impairment of oral function. The present study investigated the prevalence of trismus and its impact on oral health-related quality of life (OHRQoL) in patients treated for oral squamous cell carcinoma (OSCC). The maximum inter-incisal mouth opening of hundred OSCC patients was recorded at post-treatment and 3 months post-treatment. OHRQoL questionnaire (OHIP-14) was intervened to assess the OHRQoL of patients post-treatment and 3 months follow-up, with emphasis on correlation with grades of trismus. The prevalence of trismus was 16% pre-treatment, 72% post-treatment, and 62% at 3 months after treatment. The overall OHIP-14 scores indicated that patients with trismus reported greater impairment of OHRQoL than those without trismus at the end of treatment and 3 months follow-up. At the end of treatment, patients with severe trismus demonstrated a higher mean OHIP-14 score (23.47 ±3.34) than those with moderate (17.72 ±2.83) and mild trismus (12.66 ±3.84) with statistically significant differences (p <0.001). Equivalent results were obtained at 3 months follow-up period. Patients with trismus suffer greater impairment of OHRQoL. The findings demand the need of identifying risk factors for developing trismus and early institution of newer/modified treatment approaches for better OHRQoL in OSCC survivors.
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