European Journal of Cardiovascular Medicine

Oral cavity lesions, particularly premalignant and malignant types, are an important cause of morbidity and mortality worldwide. Oral cancer ranks among the top three cancers in South and Southeast Asia, with India carrying a disproportionate burden due to the widespread prevalence of risk factors such as tobacco chewing, smoking, betel quid use, alcohol consumption, and poor oral hygiene. According to global estimates, over 500,000 new cases of oral cancer occur annually, with less than 50% of affected patients surviving beyond five years of diagnosis. In India, the incidence is particularly high, with approximately 12.8 men and 7.5 women per 100,000 individuals affected, making oral cancer the most common malignancy among Indian men. The peak age group is between 50 and 70 years, though younger patients are increasingly being diagnosed due to early adoption of risk habits.^[1]

Premalignant lesions represent morphologically altered tissues with a higher risk of malignant transformation. Common examples include leukoplakia, erythroplakia, and oral submucous fibrosis. These conditions often precede the development of oral squamous cell carcinoma (OSCC), which accounts for more than 90% of oral malignancies in India. Early recognition of these lesions is therefore vital. While clinical examination provides preliminary clues, histopathological evaluation remains the gold standard for diagnosis, grading of dysplasia, and therapeutic planning.^[2]

The oral cavity is lined by stratified squamous epithelium, which is exposed to a wide array of carcinogens, mechanical trauma, and infections. The common sites for precancerous and malignant changes include buccal mucosa, gingivo-buccal sulcus, alveolus, tongue, floor of the mouth, and hard palate. Among these, buccal mucosa and tongue are particularly vulnerable in Indian populations due to direct placement of tobacco quid in these areas. Epidemiological data suggest that oral cancer is a disease of socioeconomic disparities. Low socioeconomic groups are disproportionately affected due to lack of awareness, delayed healthcare access, and sustained exposure to carcinogenic habits. Factors such as educational level, occupation, rural versus urban residence, and dietary practices significantly influence risk patterns and clinical outcomes. Studies have also shown regional variation across India, making local profiling of patients essential for planning targeted preventive and diagnostic interventions.^[3]

Histopathological evaluation is indispensable in characterizing the biological potential of lesions. The World Health Organization (WHO) classifies oral epithelial lesions into non-dysplastic, dysplastic, carcinoma in situ, and invasive carcinoma. Squamous cell carcinoma is further graded into well-differentiated, moderately differentiated, and poorly differentiated, with prognosis worsening with advancing grade and stage. Histological typing, combined with sociodemographic and clinical data, provides a holistic understanding of the disease burden in a given population.^[4]

Western India, including regions like Maharashtra, Gujarat, and Rajasthan, exhibits high prevalence of tobacco chewing and betel quid practices, making it an ideal setting to study the interplay between sociodemographic determinants and histopathological features. Despite this burden, limited region-specific literature exists on comprehensive sociodemographic and histopathological profiling. Most studies are confined to urban tertiary care centers, whereas rural and tribal populations, who bear the greatest risk, remain understudied.^[5]

Aim

To study the sociodemographic and histopathological profile of premalignant and malignant oral cavity lesions in Western India.

Objectives

1. To evaluate the sociodemographic characteristics (age, sex, residence, education, occupation, socioeconomic class, and habits) of patients with premalignant and malignant oral cavity lesions.
2. To study the histopathological spectrum of premalignant and malignant lesions in the oral cavity.
3. To analyze the correlation between sociodemographic variables and histopathological patterns of oral cavity lesions.

Source of Data

The study utilized oral cavity biopsy and excision specimens received at the histopathology section of the Department of Pathology, B.K.L. Walawalkar Rural Medical College, Maharashtra. Relevant clinical details were obtained from hospital records, patient interviews, and case proformas.

Study Design

A prospective observational study was conducted.

Study Location

The study was carried out at a tertiary care teaching hospital located in Western India, catering to rural, tribal, and urban populations.

Study Duration

The study period extended from December 2020 to June 2022.

Sample Size

The sample size was estimated to be 88.

Inclusion Criteria

• Patients aged >18 years of both sexes.
• Oral cavity biopsy/excision specimens diagnosed as premalignant or malignant mucosal lesions.

Exclusion Criteria

• Benign and non-neoplastic oral cavity lesions.
• Recurrent malignant lesions following treatment of primary oral cancer.

Procedure and Methodology

Patients attending ENT and Dental outpatient departments with oral cavity lesions such as ulcers, white/red patches, or growths were evaluated. Detailed history regarding onset, duration, addiction to tobacco/alcohol, dietary habits, and family history of malignancy was recorded. Clinical examination included inspection and palpation of lesion size, site, morphology, and associated features such as trismus or submucosal fibrosis.

Eligible patients underwent incisional or excisional biopsy depending on lesion size and accessibility. Specimens were fixed in 10% neutral buffered formalin, processed routinely, and embedded in paraffin. Sections were cut at 4-5 µm thickness and stained with hematoxylin and eosin (H&E). Slides were examined microscopically for features of epithelial dysplasia, keratosis, oral submucous fibrosis, and squamous cell carcinoma. Carcinomas were graded into well, moderately, and poorly differentiated types.

Sample Processing

• Fixation: 10% formalin.
• Grossing: Documentation of site, size, and gross morphology.
• Processing: Standard paraffin embedding.
• Staining: H&E staining for histopathological diagnosis.

Data Collection

A structured clinical proforma was used to collect data on sociodemographic variables (age, sex, residence, education, occupation, socioeconomic status), clinical features (site, presenting complaints, duration, addictions), and histopathological diagnosis.

Statistical Methods

Data entry and statistical analysis were performed using SPSS (IBM) version 21.0. Descriptive statistics included frequencies, percentages, means, and standard deviations. Chi-square test was used to assess associations between categorical variables. p value <0.05 was considered statistically significant.

Table 1: Baseline profile of patients (N = 88)

The study included 88 patients with premalignant (n=26) and malignant (n=62) oral cavity lesions. The overall mean age was 49.1 ± 7.2 years, with group means showing 47.6 ± 7.0 years in premalignant and 49.8 ± 7.2 years in malignant cases. The difference was not statistically significant (t = 1.42, p = 0.159). Males constituted the majority of the cohort (67.0%, 95% CI: 56.7-76.0) compared to females (33.0%, 95% CI: 24.0-43.3), but no significant sex difference was noted between the two groups (χ² = 0.05, p = 0.830). Most patients resided in rural areas (58.0%), followed by urban (27.3%) and tribal populations (14.8%), with no significant association between residence and lesion type (χ² = 1.50, p = 0.473). Regarding educational status, illiteracy was predominant (65.9%), while only 2.3% had graduate-level education or higher. Although illiteracy was higher among malignant cases, the education variable did not show significant correlation with lesion type (χ² = 5.27, p = 0.153).

Table 2: Personal habits and comorbidities (N = 88)

Tobacco chewing was the most prevalent risk factor, present in 83.0% (95% CI: 73.8-89.4) of patients, with comparable distribution between premalignant (80.7%) and malignant (83.9%) groups (χ² = 0.12, p = 0.724). Similarly, tobacco smoking was observed in 75.0% (95% CI: 65.0-82.9), without significant difference between groups (χ² = 0.66, p = 0.418). Alcohol consumption was documented in 22.7% of cases, again evenly distributed (χ² = 0.00, p = 0.960). Comorbid conditions were relatively uncommon: hypertension (11.4%) and diabetes mellitus (9.1%), with no significant differences between lesion types (p > 0.7 for both). Thus, while tobacco-related habits were highly prevalent across the cohort, their association with lesion type did not reach statistical significance in this sample.

Table 3: Clinical presentation and site (N = 88)

The most common presenting symptom was non-healing ulcer, seen in 79.5% (95% CI: 70.0-86.7) of cases, followed by growth or lump in 17.0% and white patch in 3.4%. Dental health varied, with 46.6% reporting good status, 20.5% fair, and 33.0% poor. Site-wise distribution showed that buccal mucosa was the most commonly affected location (62.5%, 95% CI: 52.1-71.9), followed by alveolus (28.4%), tongue (4.5%), and gingiva (4.5%). Site distribution did not differ significantly between premalignant and malignant groups (χ² = 1.79, p = 0.618). These findings reflect the classical clinical spectrum of oral lesions in Indian populations, with buccal mucosa being the site most exposed to chewing tobacco.

Table 4: Histopathology and stage (Premalignant n=26; Malignant n=62) + Key associations

Among premalignant lesions (n=26), keratosis without dysplasia (42.3%) was the most frequent, followed by keratosis with mild-moderate dysplasia (26.9%), severe dysplasia (15.4%), and oral submucous fibrosis (15.4%). Malignant cases (n=62) were dominated by well-differentiated squamous cell carcinoma (77.4%, 95% CI: 65.6-86.0), with moderately differentiated (16.1%) and poorly differentiated (6.5%) types forming the remainder. Staging revealed that 72.6% of malignant cases were T2N1 and 27.4% were T3N1. Associations tested between sociodemographic and clinical variables with lesion type showed no significant correlations for sex, age group, residence, site, or personal habits (p > 0.4 for all). However, educational level trended towards significance (χ² = 5.27, p = 0.153), with illiteracy more frequent in malignant cases.

Table 1 (Baseline profile). Cohort’s mean age (49.1 ± 7.2 years) with a male preponderance (67.0%) mirrors the typical Indian oral-lesion epidemiology, where cases peak in the 5th-6th decades and men outnumber women by ~2-4:1 due to higher exposure to tobacco and alcohol. The nonsignificant age difference between premalignant and malignant groups (t=1.42, p=0.159) is consistent with hospital-based series showing overlap in age bands for OPMDs and early OSCC presentations Gupta I et al.(2021)^[6]. The predominance of rural residence (58.0%) and high illiteracy (65.9%) track well with evidence linking low socioeconomic status and delayed care to oral cancer risk and later presentation in India. Although education trended toward higher illiteracy in malignant cases, the overall association with lesion type was nonsignificant (χ²=5.27, p=0.153), likely reflecting limited power and the fact that socioeconomic disadvantage is common across both strata in Western India referral populations. Sex distribution did not differ by lesion type (χ²=0.05, p=0.830), echoing multi-center OPMD/OSCC series where sex shifts become clearer mainly when stratifying by specific habits (e.g., smokeless vs smoked tobacco) rather than by lesion category alone Gaddikeri K.et al.(2023)^[7].

Table 2 (Habits & comorbidity). Very high exposure to tobacco-chewing 83.0% and smoking 75.0%-is in line with Indian OPMD/OSCC literature in which smokeless tobacco and mixed habits are the dominant risks, particularly in Western and Central India [2,5,7]. Despite face-valid risk gradients, none of the habits differed significantly by lesion type (chewing χ²=0.12, p=0.724; smoking χ²=0.66, p=0.418; alcohol χ²=0.00, p=0.960). Two methodologic explanations are common in clinic-based series: (i) ceiling effects from near-universal exposure that compress between-group contrasts; and (ii) sample-size limitations for moderate effect sizes once stratified George GS et al.(2025)^[8]. Comorbidities were infrequent (hypertension 11.4%, diabetes 9.1%) and balanced across groups, similar to other Indian surgical pathology cohorts where cardiometabolic comorbidity has limited discriminatory value for OSCC vs OPMD when compared with lifestyle risks Nishat R et al.(2021)^[9].

Table 3 (Clinical presentation & site). The leading symptom was a non-healing ulcer (79.5%), followed by growth/lump (17.0%), with white patch (3.4%) least common-precisely the pattern reported in several South Asian series where symptomatic ulceroproliferative lesions drive presentations to ENT/Dental clinics. Site distribution favored buccal mucosa (62.5%), then alveolus (28.4%), with tongue/gingiva less frequent (each 4.5%). This buccal predominance is a hallmark of Indian practice, plausibly due to quid placement and chronic chemical-mechanical irritation at the gingivobuccal complex Jain A et al.(2023)^[10]. The absence of a site-lesion-type association (χ²=1.79, p=0.618) is unsurprising; many centers observe similar anatomical predilections for both OPMDs and OSCC, with severity diverging more by histological grade and stage than by site alone Rathod G et al.(2025)^[11].

Table 4 (Histopathology, stage & associations). Among premalignant lesions, the spectrum-keratosis without dysplasia (42.3%), mild-moderate dysplasia (26.9%), severe dysplasia (15.4%), and OSMF (15.4%)-aligns with reports where leukoplakia-spectrum lesions dominate OPMDs, followed by OSMF in areca-nut-using regions Deosthale N et al.(2023)^[12]. Among cancers, well-differentiated SCC (77.4%) predominated, with fewer moderately (16.1%) and poorly (6.5%) differentiated tumors-very similar to hospital series from North and Western India. Most malignant cases were T2N1 (72.6%) rather than T3N1, suggesting substantial-but not early-presentation; this mid-stage clustering is repeatedly attributed to delayed symptom appraisal and referral pathways in rural belts Shridhar K et al.(2021)^[13]. Across tested associations, sex, age group, residence, site, and habits were not different between premalignant and malignant categories (all p>0.4), echoing other single-center datasets where sociodemographic and habit exposures are prevalent across the entire lesion continuum. In such contexts, progression risk is better discriminated by histologic dysplasia grade, molecular markers, and duration/intensity of exposure, which were beyond the scope of routine diagnostics in many centers Agarwal AK et al.(2021)^[14].

The present study highlights that oral cavity premalignant and malignant lesions in Western India predominantly affect individuals in the fifth to sixth decades of life, with a clear male preponderance and a major share of patients belonging to rural and socioeconomically disadvantaged groups. High illiteracy rates and widespread use of tobacco in both smoked and smokeless forms were common to nearly all patients, underscoring the role of lifestyle and sociocultural factors in disease causation. Clinically, most patients presented with non-healing ulcers, with buccal mucosa being the most frequent site, reflecting the local habit of quid placement. Histopathologically, leukoplakia spectrum changes and oral submucous fibrosis were the main premalignant entities, while well-differentiated squamous cell carcinoma was the dominant malignant lesion, with the majority presenting at intermediate stage (T2N1). The absence of statistically significant differences between premalignant and malignant groups for most sociodemographic variables highlights the pervasive influence of tobacco-related practices across the continuum of disease. Overall, the findings reinforce the urgent need for targeted community-based preventive strategies, early screening programs, and timely histopathological diagnosis to reduce the burden of oral cancer in this high-risk region.

LIMITATIONS

This study was limited by its single-center design and modest sample size (n=88), which may restrict the generalizability of findings to the wider population of Western India. Detailed quantification of risk factors such as duration, frequency, and intensity of tobacco or alcohol use could not be assessed, which may have obscured dose-response relationships. Staging data were restricted to available clinical and histopathological records, and advanced molecular or biomarker studies were not performed, limiting the ability to explore predictors of malignant transformation beyond routine histology. Furthermore, follow-up information on progression of premalignant lesions to malignancy was not available, preventing assessment of longitudinal outcomes. Despite these constraints, the study provides valuable baseline information for a rural and semi-urban cohort in a high-burden setting.

1. Shruti T, Khanna D, Khan A, Dandpat A, Tiwari M, Singh AG, Mishra A, Shetty A, Birur P, Chaturvedi P. Status and determinants of early detection of oral premalignant and malignant lesions in India. Cancer Control. 2023 Feb 17;30:10732748231159556.
2. Sahoo PK, Sarkar S, Ghosh D, Mahata S, Pal R, Mistry T, Ghosh S, Roy A, Bucha H, Mandal S, Nasare VD. Premalignant and malignant lesions of oral cavity in eastern India: a hospital-based study. European Journal of Cancer Prevention. 2021 Sep 1;30(5):393-9.
3. Ghai S, Sharma Y. Demographic profile of benign and malignant oral tumors in Central India: A retrospective comparative study. Cureus. 2022 May 26;14(5).
4. Srivastava R, Sharma L, Pradhan D, Jyoti B, Singh O. Prevalence of oral premalignant lesions and conditions among the population of Kanpur City, India: A cross-sectional study. Journal of family medicine and primary care. 2020 Feb 1;9(2):1080-5.
5. Dhage DH, Hiwarkar PA, Kawalkar UG, Joge U, Malkar V, Soyam G. Clinical profile and socioeconomic status of oral cancer patients attending tertiary care centre in India. Age (years). 2025;25(1):0-8.
6. Gupta I, Rani R, Suri J. Histopathological spectrum of oral cavity lesions–A tertiary care experience. Indian Journal of Pathology and Oncology. 2021;8(3):364-8.
7. Gaddikeri K. Clinical-pathological Study Of Patients With Oral Potentially Malignant Disorders. Int J Acad Med Pharm. 2023;5(3):609-15.
8. George GS, Singh A, Moirangthem R, Patil A, Pullat GB, Sagare S, Krishnatreya M, Mishra A, Sonwane R, Hosseini B, Chaturvedi A. Association of Decayed, Missing, Filled Teeth Score With the Risk for Buccal Mucosa Cancer, Stratified on Tobacco and Alcohol Use: A Multicenter Case-Control Study From India. JCO Global Oncology. 2025 Jul;11:e2500119.
9. Nishat R, Jaiswal MM, Kumari N, Jha PC, Bhuyan L. A Study on Prevalence of Oral Mucosal Lesions in the Geriatric Population of Eastern India. Annals of the Romanian Society for Cell Biology. 2021;25(1):6772-85.
10. Jain A, Narve VP. To Study Clinical and Socio-Demographic Profile of Oral Submucous Fibrosis. European Journal of Cardiovascular Medicine. 2023 Jan 1;13(1).
11. Rathod G, Chawdhury AD, Somalwar SB, Pradeep I, Singh NK. PD-L1 Expression in Head and Neck Squamous Cell Carcinoma and Precursor Squamous Lesions: A Single-Center Study in South India. Indian Journal of Otolaryngology and Head & Neck Surgery. 2025 Jun 28:1-9.
12. Deosthale N, Khursheed M, Choudhary S, Khadakkar SP, Nagwekar C, More H, Amar Methwani D. Sociodemographic and clinical profile of oral submucous fibrosis. Indian Journal of Otolaryngology and Head & Neck Surgery. 2023 Dec;75(4):3373-8.
13. Shridhar K, Aggarwal A, Rawal I, Gupta R, Masih S, Mehrotra R, Gillespie TW, Dhillon PK, Michaud DS, Prabhakaran D, Goodman M. Feasibility of investigating the association between bacterial pathogens and oral leukoplakia in low and middle income countries: A population-based pilot study in India. PLoS One. 2021 Apr 29;16(4):e0251017.
14. Agarwal AK, Mahore R, Bhadoriya SS, Tripathi A, Saraswat S. A clinico-epidemiological hospital based study of oral cancer patients in Gwalior district. Indian J Forensic & Community Med. 2021;8(2):132-8.