IMMPACT-recommended outcome measures and tools of assessment in burning mouth syndrome RCTs: an international Delphi survey protocol.

BACKGROUND: A core outcome set (COS) represents the agreed minimum set of domains and measurement instruments that should be measured and reported in any clinical trial for a given condition. In BMS randomized controlled trials (RCTs), the outcomes identified in the existing literature regarding the efficacy of therapeutic interventions are numerous and diverse. Although the standardized IMMPACT core outcome domains has been developed for measurement of outcomes in chronic pain RCTs, no BMS-specific COS have been adopted and validated. With the evolving landscape of BMS management end points and the development of new therapies, a consensus on a COS for use in future BMS trials is paramount to reduce heterogeneity in outcome reporting. The aim of this study was to reach a consensus for adopting the standardized Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) outcome domains, and their tools of assessment, for burning mouth syndrome (BMS) clinical trials and clinical practice. METHODS: A BMS-specific COS will be developed using the method recommended by the Core Outcome Measures in Effective Trials (COMET) initiative (Registration: http://www.comet-initiative.org/studies/details/1357 ). Selection of questionnaire outcome measures was informed by the IMMPACT consensus and previous systematic review of RCTs in BMS conducted by the consortium. An international group of clinicians and researchers will be invited to participate in several rounds of a Delphi survey. A consensus meeting will be held with the objective of ratifying the outcomes for inclusion in the COS. A finalized COS explanatory document will be drafted, including all outcomes and measurements as determined by the Delphi rounds and consensus meeting. DISCUSSION: A COS for the management of BMS will improve the quality of future RCTs, reduce outcome reporting heterogeneity, and facilitate more vigorous data synthesis of management interventions for systematic reviews and meta-analysis. This would ensure enhanced quality evidence for clinical management of the condition.

Malignant transformation of oral leukoplakia: a systematic review of observational studies.

UNLABELLED: The aim of this systematic review was to ascertain the malignant transformation rate of oral leukoplakia and the associated risk factors. METHOD: Published literature was searched through several search engines from 1960 to the end of December 2013. The inclusion criteria included 'leukoplakia', 'pre-cancer', 'malignant transformation', 'follow-up' and 'outcome'. Two reviewers extracted the data independently and also assessed the quality of evidence. RESULTS: The search strategy resulted in 1032 abstracts or full-text articles, of which 24 met the inclusion criteria. There was much variation in the definitions used by the various authors in their original reports to define oral leukoplakia or in the criteria used to recruit their patients for follow-up. The estimated overall (mean) malignant transformation rate for the total population described in these 24 studies amounts to 3.5% (405/11423), with a wide range between 0.13% and 34.0%. Based on the evidence presented, the features that stand out as significant determinants contributing to malignant potential of OL include advanced age, female sex, leukoplakia exceeding 200 mm(2) , non-homogeneous type (eg. erythroleukoplakia) and the higher grades of dysplasia. CONCLUSION: The review indicates that drawing meaningful evidence-based conclusions are difficult from retrospective studies of this nature. However, many of the determinants exposed in the review require further investigation by well-designed prospective studies.

Declining oral cancer rates in Sri Lanka: are we winning the war after being at the top of the cancer league table?

OBJECTIVES: To investigate the age-standardized incidence, demography, recent trends and patterns of incidence of oral cancer in Sri Lanka between 1985 and 2005. MATERIALS AND METHODS: Data on oral and oropharyngeal cancers were obtained from the published hospital-based cancer registry reports in the years 1985, 1990, 1995, 2000, and 2005. The data were analyzed by gender, age (<40 or >40 years), and by site. A linear regression analysis was performed on the age-standardized oral and oropharyngeal cancer incidence rates to examine the trends over a 20-year period. RESULTS: There was a steady decline in the age-standardized incidence of lip and oral cavity cancers over the past 20 years in both men and women. A significant reduction of 1.9% per year is noted over this period. Contrary to this, cancers of the oropharynx (C09, C10, and C14) showed a slight increase over the same period. CONCLUSIONS: Reversal of betel quid use and smoking must be considered in accounting for declining trends for oral cancer. Increasing rates of oropharyngeal cancer raises the issue whether risk factors for the oropharynx are different to those of the oral cavity, and this may need further investigation.

Fingerprinting genomic instability in oral submucous fibrosis.

BACKGROUND: Oral submucous fibrosis (OSF) is a high-risk pre-cancerous condition where 7-13% of these patients develop head and neck squamous cell carcinoma (HNSCC). To date there is no cancer predictive markers for OSF patients. Genomic instability hallmarks early genetic events during malignant transformation causing loss of heterozygosity (LOH) and chromosomal copy number abnormality. However, to date there is no study on genomic instability in OSF. Although this condition is known as a high-risk pre-cancerous condition, there is no data regarding the genomic status of this disease in terms of genetic susceptibility to malignant transformation. METHODS: In this study, we investigated the existence of genetic signatures for carcinogenesis in OSF. We employed the high-resolution genome-wide Affymetrix Mapping single nucleotide polymorphism microarray technique to 'fingerprint' global genomic instability in the form of LOH in 15 patient-matched OSF-blood genomic DNA samples. RESULTS: This rapid high-resolution mapping technique has revealed for the first time that a small number of discrete hot-spot LOH loci appeared in 47-53% of the OSF tissues studied. Many of these LOH loci were previously identified regions of genomic instability associated with carcinogenesis of the HNSCC. CONCLUSION: To our knowledge, this is the first evidence that genomic instability in the form of LOH is present in OSF. We hypothesize that the genomic instability detected in OSF may play an important role in malignant transformation. Further functional association studies on these putative genes may reveal potential predictive oral cancer markers for OSF patients.

Upregulation of HIF-1alpha in malignant transformation of oral submucous fibrosis.

BACKGROUND: Oral submucous fibrosis (OSF) is a precancerous condition showing extensive fibrosis of the submucosa and affects most parts of the oral cavity, including pharynx and upper third of the oesophagus. The molecules involved in the biological pathways of the fibrotic process appeared to be either down- or upregulated at different stages of the disease. Despite the precancerous nature, malignant transformation of the epithelium in the background of fibrosis has not been studied in detail. HIF-1alpha is a known transcription factor that is induced by hypoxia. AIMS: To test the hypothesis that hypoxia plays a role in malignant transformation and progression of OSF. MATERIALS AND METHODS: We used both formalin-fixed and frozen samples of OSF and normal mucosa to investigate the relationship between HIF-1alpha and epithelial dysplasia using immunohistochemistry and RT-PCR. CONCLUSIONS: Our data indicate that HIF-1alpha is upregulated at both protein and mRNA levels in OSF and the correlation with epithelial dysplasia is statistically significant (P < 0.001). We propose that HIF-1alpha may play a role in malignant transformation of OSF. Further, over-expression of HIF-1alpha may contribute to the progression of fibrosis. It may be possible to use HIF-1alpha as a marker for malignant transformation of OSF.

Screening for oral cancer/pre-cancer: knowledge and opinions of dentists employed in the public sector dental services of Sri Lanka.

OBJECTIVE: The aim of the present study was to assess knowledge and opinions related to oral cancer screening among dentists employed in public sector dental services in Sri Lanka. MATERIALS AND METHODS: The study population consisted of a total of 1,020 dentists employed in the public sector dental services as at December 2007. The data were collected by means of a postal questionnaire consisting of 23 items focusing on demographic characteristics, knowledge and opinions about screening for oral cancer/precancer. RESULTS: 387 completed questionnaires were returned giving a response rate of 38%. The overall knowledge score for oral cancer screening was 2.79. There were no significant differences between time since graduation, position held and knowledge scores. Around 68-70% of respondents agreed/strongly agreed that their knowledge about oral cancer/pre cancer was current. Though 77% agreed/strongly agreed that dentists are adequately trained in oral cancer screening, nearly 63% disagreed/strongly disagreed that medical officers are adequately trained to perform oral screening. Nearly 81% agreed/strongly agreed that they were adequately trained in oral cancer screening whilst 70% also felt that they needed further training in oral cancer screening. CONCLUSIONS: the results revealed that a fairly large proportion of respondents were knowledgeable about oral cancer screening but as there was a reasonable percentage whose knowledge about oral cancer screening was poor there is a need for continuing education programmes.

Prevalence of oral cancer and pre-cancer and associated risk factors among tea estate workers in the central Sri Lanka.

BACKGROUND: To screen for oral cancer or not is being debated, but for high-risk populations with minimal access to regular dental care systematic oral examinations could provide some benefit. METHODS: We undertook oral mucosal examinations of labourers employed in tea estate plantations in Sri Lanka. In a two-stage screening procedure, first by estate medical officers and then by visiting specialists, we examined 12 716 persons at their workplaces achieving a coverage of one-sixth of the total workforce. RESULTS: Fourteen oral cancers and 848 subjects with oral pre-cancer (6.7%) were detected giving population prevalences of 46.1 per 1000 for leukoplakia and 16.4 per 1000 for oral submucous fibrosis. Among subjects with any oral mucosal disorder (n = 1159) proportions of current users of betel quid, smokers and alcohol use was recorded at 92%, 31% and 61% respectively. The synergistic effect of these three risk habits on the development of oral leukoplakia was evident in mixed habit groups. CONCLUSIONS: The prevalence of oral pre-cancer in tea estate labourers was higher than estimates reported in previous studies. In the absence of state-sponsored preventive activities, it is necessary to improve the capacity of individual health practitioners and small medical centres to participate in oral health promotion and oral cancer/pre-cancer screening.

Oral submucous fibrosis and oral yeast carriage - a case control study in Sri Lankan patients.

Oral submucous fibrosis (OSMF) is a well-known precancerous condition. Epithelial atrophy is one of the key features in OSMF. Presence of Candida in the mouth together with epithelial changes may predispose to candidal infection. Candidal infection together with other co-factors may also induce epithelial atypia and dysplasia leading to malignant change. The purpose of this study was to determine the prevalence of oral yeast carriage in patients with OSMF and to compare the carriage with the normal individuals. Thirty patients with histologically proven OSMF and healthy subjects were used as the test and control respectively. Oral rinse samples were collected from all the subjects and cultured on Sabouraud's agar. Species were identified using API 32C AUX identification kits. Nineteen (63.6%) of the test group and 15 (50%) of the control group had yeast isolated from their mouth. The carriage of yeast in the OSMF group was not statistically significant compared with the control group. We isolated C. dubliniensis in Sri Lanka for the first time and interestingly from the oral cavities of both OSMF patients and healthy individuals.

Effect of betel chewing, tobacco smoking and alcohol consumption on oral submucous fibrosis: a case-control study in Sri Lanka.

BACKGROUND: Oral submucous fibrosis (OSMF) is a chronic, insidious, disabling potentially malignant condition of the oral mucosa seen predominantly in south and Southeast Asia. No reports are hitherto available on the aetiological factors of OSMF based on Sri Lankan patients. METHODS: A total of 74 patients with OSMF and 74 controls who consecutively attended the Oral Medicine clinic at the Dental Hospital (Teaching) Faculty of Dental Sciences, University of Peradeniya, Sri Lanka were included in the study. Binary logistic regression analyses were performed to model the influence of betel chewing, smoking and alcohol use and to determine the effects of different combinations of chewing habits on OSMF. RESULTS: Betel chewing was the only significantly associated factor in the aetiology of OSMF (OR = 171.83, 95% CI: 36.35-812.25). There were no interaction effects of chewing, smoking and alcohol consumption in the causation of OSMF. CONCLUSION: The present study has shown a strong association of betel quid chewing (including tobacco as an ingredient) with the causation of OSMF.

Oral pemphigus vulgaris in children and adolescents: a review of the literature and a case report.

This paper describes a case of oral pemphigus vulgaris (PV) in a child that was diagnosed in its early stages and managed successfully. The authors also report a literature review. Although oral PV in children and adolescents is extremely rare, it should be included in the differential diagnosis of oral ulcerative disease. It is of utmost importance to diagnose PV in children and adolescents in its initial stages in order to prevent the serious morbidity that may result from the disease, and to institute phamacotherapeutic measures so that they have the greatest effect. Furthermore, it is essential for dentists to be aware of the existence of PV in child and adolescent patients so that they may refer such cases for specialist management without undue delay.

Awareness of oral cancer and precancer among patients attending a hospital in Sri Lanka.

OBJECTIVE: To assess awareness about oral cancer and precancer among patients attending for dental treatment at a University Dental hospital. METHODS AND MATERIALS: A self-administered questionnaire was used to collect information from 410 randomly selected outpatients attended the Dental Hospital (teaching), Faculty of Dental Sciences, University of Peradeniya, Sri Lanka. The questionnaire included questions to ascertain information on socio-demographic parameters, awareness of oral cancer and precancer, habits of betel chewing, smoking and alcohol consumption. RESULTS: Ninety five percent of the respondents were aware of the possibility of occurrence of cancer in the mouth while only 44.9% (n=184) were aware about precancer. Of the 390 individuals who were aware of the existence of oral cancer, 80.7% were knowledgeable about the causal relationship between betel chewing habit and oral cancer. Forty-seven and 17 percent were aware of links with tobacco smoking and alcohol consumption, respectively. However, out of those who had knowledge of oral cancer, 18 % (n=69) were not knowledgeable about associations with habits. CONCLUSIONS: This survey revealed that the patients attending the hospital were well informed about oral cancer. However, awareness about precancer was relatively low. Knowledge about the causal relationships with tobacco smoking and use of alcohol was low compared to that for betel chewing.

Oral psoriasis in an 11-year-old child: a case report.

Psoriasis is a chronic inflammatory dermatosis that very rarely involves the oral mucosa. There is no consistent pattern of clinical presentation in the oral cavity. Furthermore, manifestations of intraoral psoriasis in paediatric patients are extremely rare and only one case appeared to have been reported in the literature to date. In this paper we report a case of intraoral psoriasis in an 11-year-old child who had been previously diagnosed as having dermal psoriasis.