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.

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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Oral Psychosomatic Disorders in Family Caregivers of Oral Squamous Cell Carcinoma Patients.

OBJECTIVE: To investigate the oral psychosomatic disorders (PSDs) in family caregivers (FCs) of oral cancer (OC) patients and to evaluate the correlation between these oral PSDs to severity of depression anxiety and stress. METHODS: A total of 50 participants were included each in first degree relative (FDR), second degree relative (SDR) and control group. All the participants completed DASS-21 questionnaire and were subjected to thorough clinical history and oral examination. RESULTS: All the FCs reported statistically significant higher mean levels of depression, anxiety and stress compared to controls (p˂0.001). A significantly greater number of FCs (40.00%) reported oral PSDs than control group (12.00%). Most prevalent oral PSD in FCs was aphthous stomatitis followed by oral lichen planus, bruxism, burning mouth syndrome and myofascial pain dysfunction syndrome. Moreover, there was a preponderance of these diseases in FDR (60.86%) compared to SDR (26.08%). FCs with moderate to very severe depression, anxiety and stress showed higher prevalence of these oral PSDs compared to the ones with mild depression, anxiety and stress. CONCLUSION: The observations of higher prevalence of oral PSDs in FCs with psychological alterations can enhance healthcare professionals' awareness to better understand FCs' oral healthcare needs.
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Oro-facial opportunistic infections and related pathologies in HIV patients: A comprehensive review.

Among all the viral infections, acquired immunodeficiency syndrome (AIDS) is considered as one of the most morbid infections caused by the human immunodeficiency virus (HIV). The prime reason for the pathogenesis is the profound immunosuppression that leads to lethal opportunistic infections (OI), neurological disorders, unexpected malignancies and pathologies of the orofacial region. Patients with OI whose HIV status is unknown have shown a mortality rate higher than those with known HIV status. Among HIV-associated infections, orofacial lesions contribute a major proportion of the OI attributed to the plethora of micro-organisms present in the oral cavity. Apart from serious clinical manifestations, opportunistic infections also lead to significant impairment of quality of life. These lesions not only indicate the HIV infection but also among the clinical manifestations, which often occur early in the course of disease. World Health Organization has also provided policies for treatment/prevention of oral lesions, strengthening the promotion and care of oral health in HIV/AIDS patients. The present review provides comprehensive information about orofacial OI in HIV/AIDS patients and emphasis was also given to the malignancies associated with EB and HTLV virus.

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.

Clinical efficacy of mouth exercising devices in oral submucous fibrosis: A systematic review.

BACKGROUND: The management of oral submucous fibrosis (OSF) is primarily focused towards minimizing patient's symptoms and to prevent cancer development. Mouth exercise physiotherapy independently or in combination with other modalities is considered to be a mainstay for increasing the mouth opening (MO). The present systematic review was performed to identify different mouth exercising devices (MEDs) used and to provide detailed information on the fabrication and clinical efficacy of these devices among OSF patients. METHODS: PubMed, Scopus, Web of Science, Google Scholar and CINAHL were searched for relevant literature until February 2019 and the information was extracted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. All full text papers describing use of MED in OSF patients were considered eligible. RESULTS: Initial search resulted in 88 hits. After removing duplicates and screening of titles and abstracts, five papers that met the inclusion criteria were included. We identified five MEDs used for increasing the MO in OSF patients. Only one study administered additional treatment with topical steroids, oral antioxidants and ice-cream stick regime. The follow-up across studies ranged from 8 weeks to 6 months. Majority of the studies reported significant improvement in the MO without any relapse and side effects. CONCLUSIONS: MED could play an important role in the management of OSF. Limited researches in this area suggest a dire need for the further investigations using randomized controlled trials.

Measurement properties of oral health related patient reported outcome measures in patients with oral cancer: A systematic review using COSMIN checklist.

BACKGROUND: Oral cancer (OC) is one of the common malignant neoplasm resulting in a range of debilitating symptoms. Patient reported outcome measures (PROMs) could provide a valuable insight into the impact of OC on patients' quality of life (QoL). Selecting an adequate instrument among available PROMs for OC has been challenging for clinicians due to lack of information on their psychometric quality. This systematic review provides an extensive overview of methodological quality of all currently available PROMs for OC. METHOD: A systematic search was performed in PubMed, Scopus, Web of Science and CINAHL for relevant literature until 10th January 2019 and data was extracted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The quality of the identified studies was assessed per measurement property according to the COnsensus-based Standards for the selection of health Measurements Instruments (COSMIN) checklist. RESULTS: Seven studies were found evaluating 6 health-related QoL PROMs. Among six, there were 1 disease-specific and 5 generic PROMs. Information regarding important measurement properties was often incomplete. The evidence for the quality of measurement properties was found to be variable, none of the instruments performed sufficient on all measurement properties. Considering results of this review, QOL-OC appeared to have adequate COSMIN measurement properties. CONCLUSION: QOL-OC can be implemented in future studies to better understand symptoms and expectations of OC patients and help inform clinicians to formulate treatment strategies as per patients' needs.

Assessment of oral health-related quality of life instruments for oral submucous fibrosis: A systematic review using the COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) checklist.

Quality of life (QoL) instruments are becoming increasingly important in research and often used in clinical practice. Various QoL instruments have been developed/ validated for assessment of oral health-related QoL (OHRQoL) in patients with oral submucous fibrosis (OSF). Selection of an adequate instrument is challenging in routine practice due to lack of information on psychometric quality of measurement instruments. This systematic review gives an extensive overview of quality of all the currently available measurement instruments for use in OSF patients. PubMed, Scopus, Web of Science and CINAHL were searched for relevant literature until December 2018 and the information was extracted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The quality of the identified studies was assessed per measurement property according to the COnsensus-based Standards for the selection of health Measurements Instruments (COSMIN) checklist. Four studies that met the inclusion criteria were included. Three generic and one disease-specific QoL instruments were identified. Information regarding important measurement properties was often incomplete. The evidence for the quality of measurement instruments was found to be variable, none of the instruments performed sufficient on all measurement properties. Based on the available information, OHRQoL-OSF appeared to have adequate COSMIN measurement properties. As recently published, newer QoL instruments have not yet been evaluated in an adequate manner for use in OSF. We suggest future studies should implement OSF-specific OHRQoL-OSF to better understand OSF patients' perspectives and help inform clinicians to propose treatment strategies as per patients' needs.

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.

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.

Nutrition and oral health.

To maintain health, the human body needs daily nourishment in the form of carbohydrates, proteins and minerals. The associations between oral health conditions, dietary practices and nutritional status, and general health status are complex with many interrelating factors. Inadequate nutrition can affect the oral health including dental caries, periodontal diseases, diseases of oralmucosa and infectious diseases. Compromised oral health can alter food choices and negatively impact food intake leading to suboptimal nutritional status which can lead to chronic systemic diseases. Recognizing and treating oral health and nutrition problems are important in improving the health and quality of life.

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.

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.

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.

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.

Citation Classics in Cone Beam Computed Tomography: The 100 Top-Cited Articles.

AIM: The purpose of this study was to identify and characterize the 100 most cited articles on cone beam computed tomography (CBCT). MATERIALS AND METHODS: A comprehensive list of citation classics in CBCT was generated by searching the Scopus database without year or language restrictions. The top 100 articles were retrieved after reading abstracts or full texts. The following study variables were evaluated: number of citations, citation density, journal name, impact factor, category and quartile of journals, publication year, authors with their affiliations, article type, and topics covered. RESULTS: The citation number ranged from 86 to 624, with a mean of 161.9 citations per article. The top 100 articles were distributed in 29 journals, and the journal with the most articles was Dentomaxillofacial Radiology (n=16). The articles were published between 1998 and 2012, and eight authors published more than 3 papers. The USA produced the most papers (n=38), followed by the UK (n=12). King's college London Dental Institute led the list of classics, with 8 articles. CONCLUSIONS: This is the first citation analysis to provide a detailed list of the most influential articles on CBCT and helps to recognize the quality of the works, discoveries, and trends steering the field.