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Oral Biopsy Score: A Quantitative Approach to Clinical Decision Making for Biopsies in Suspicious Oral Lesions

CC BY 4.0 · Indian J Med Paediatr Oncol 2026; 47(01): 080-082

DOI: DOI: 10.1055/s-0045-1812849

Author : Hitesh R. Singhavi?,Chanchal Dharia, Anil Heroor

Abstract

Oral potentially malignant lesions are often underdiagnosed, leading to malignant transformation, progression, and spread of disease. It is also responsible for poor survival outcomes. To save these life years, early detection is a must. Unfortunately, it requires specialist access in many clinical settings. For faster, uniform screening, a quantitative approach, the oral biopsy score (OBS), has been formulated for risk stratification and sooner decision making. The OBS consists of risk factors such as tobacco/alcohol/areca nut use, size of the lesion, morphology, duration, location, and induration of the lesion. Each of these categories has an upper and lower score assigned. Depending on the added score, the inference will guide us in performing the biopsy or keeping it under surveillance. We advocate for validation of the OBS through multicentric prospective studies to assess its diagnostic performance. Incorporation into artificial intelligence-assisted image analysis will enhance the accuracy of the diagnosis. Ultimately, we believe the OBS can play a pivotal role in early detection of oral cancer, leading to reduction in morbidity and improvement in survival.

Keywords

biopsy - oral lesions - oral cancer - leukoplakia - erythroplakia - oral potentially malignant disorder - oral biopsy score

Patient Consent

Patient consent is not required.

Publication History

Article published online:
03 November 2025

© 2025. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

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Abstract

Oral potentially malignant lesions are often underdiagnosed, leading to malignant transformation, progression, and spread of disease. It is also responsible for poor survival outcomes. To save these life years, early detection is a must. Unfortunately, it requires specialist access in many clinical settings. For faster, uniform screening, a quantitative approach, the oral biopsy score (OBS), has been formulated for risk stratification and sooner decision making. The OBS consists of risk factors such as tobacco/alcohol/areca nut use, size of the lesion, morphology, duration, location, and induration of the lesion. Each of these categories has an upper and lower score assigned. Depending on the added score, the inference will guide us in performing the biopsy or keeping it under surveillance. We advocate for validation of the OBS through multicentric prospective studies to assess its diagnostic performance. Incorporation into artificial intelligence-assisted image analysis will enhance the accuracy of the diagnosis. Ultimately, we believe the OBS can play a pivotal role in early detection of oral cancer, leading to reduction in morbidity and improvement in survival.

Keywords

biopsy - oral lesions - oral cancer - leukoplakia - erythroplakia - oral potentially malignant disorder - oral biopsy score

Introduction

Oral potentially malignant disorders (OPMDs) and early oral cancers pose significant diagnostic and management challenges in clinical practice.[1] Despite increasing awareness about the importance of early detection, a substantial number of oral cancers are diagnosed at advanced stages, largely due to delays in detection, referral, and biopsy of suspicious lesions.[2] Presence of factors like tobacco/alcohol/areca nut use, size, duration, location, and characteristics of lesions pose a higher risk of malignant transformation in oral cavity cancer, especially in the Indian population.[3] For this critical need, we propose a structured and practical scoring system, the oral biopsy score (OBS), which aims to assist in clinical decisions regarding when to biopsy oral lesions. OBS is designed to be a user-friendly, practical tool to help general practitioners, dentists, and oral medicine specialists quickly recognize which oral lesions need urgent biopsy and histopathological testing. It is designed taking into consideration the known clinical signs that suggest a higher risk of malignant changes, combining with important patient risk factors with morphology of the lesion. Based on the malignant transformation rates, values have been given to the following risk factors.

  1. Framework of the Oral Biopsy Score

    The OBS assigns scores based on the following parameters, categorized into three domains, that is, patient habit, lesion morphology, and duration. Each parameter is scored as an “upper score” or “lower score,” reflecting the presence or absence of high-risk factors [Table 1].

    1. Tobacco/alcohol/areca nut use (ever user)

      Upper: 1 (If the patient has history or is current user of above product)

      Lower: 0 (If the patient has no history of any of the above habits)

      These substances are International Agency for Research on Cancer (IARC) group 1 carcinogens, and their chronic use significantly elevates the risk of malignant transformation.[4] A systematic review by Asthana et al showed that smokeless tobacco products had a significant risk of oral cancer (4.44, 95%. confidence interval [CI] = 3.51–5.61).[5] Another meta-analysis by Gandini et al concluded that tobacco smoking also has a high risk of causing oral cancer (relative risk [RR] = 3.43; 95%. CI: 2.37–4.94).[6] Alcohol consumption significantly increases cancer risk in India, with a pooled odds ratio (OR) of 2.32 (95%. CI: 1.50–3.47) in case–control studies and nearly doubles the risk of oral cavity cancer (OR: 1.92, 95%. CI: 1.54–3.96).[7] Also, data from the IARC show that areca nut chewing also has a significantly high risk of causing oral cancer, independently (pooled adjusted RR, 7.9; 95%. CI, 7.1–8.7).[8] According to Global adult tobacco survey 2 (GATS 2), more than 30%. of all adult Indians consume tobacco. Tobacco is IARC approved Group 1 carcinogen. ACC Hence, tobacco, alcohol, and areca nut usage have been noted and given a score of 1.

    2. Size of the lesion

      Upper: 1 (> 2 cm)

      Lower: 0 (< 2>

      Larger lesions, particularly those exceeding 2 cm in diameter, are more likely to harbor dysplastic or malignant changes. A systematic review by Pimenta-Barros et al found that larger leukoplakic patches showed higher risk of malignant transformation (RR = 2.08, 1.45–2.96, p < 0.001).[9] Lesions of size more than 2 cm are more likely to have been there for a while, making malignant transformation probable. Therefore, the upper score of 1 has been allotted to larger lesions.

    3. Duration of the lesion

      Upper: 1 (> 5 years)

      Lower: 0 (< 5>

      Lesions persisting for over 5 years are more likely to have undergone dysplastic changes without intervention, warranting an upper score of 1. Chronicity is a well-known predictor of malignant transformation.[9]

    4. Site of the lesion

      Upper: 1 (Located on the tongue or floor of the mouth for all patients and located on the bucco-alveolar complex for patients with history of any habit)

      Lower: 0 (Located on the bucco-alveolar complex for patients with no history of habit and any other location for all patients)

      High-risk anatomical sites include the lateral tongue, floor of the mouth, and buccal mucosa-buccal alveolar complex (especially in chronic tobacco/areca nut abusers).[9]

    5. Lesion morphology: homogeneity

      Upper: 2 (Heterogeneous, includes speckled, nodular, verrucous varieties)

      Lower: 0 (Homogeneous)

      Nonhomogeneous oral leukoplakia has a higher transformation rate than homogeneous types. A study from Southern Iran indicated a higher risk of malignant transformation in nonhomogeneous lesions (OR = 6.26).[10] Moreover, the meta-analysis by Pimenta-Barros et al also showed that heterogeneous leukoplakia had a higher risk of malignant transformation (RR = 4.23, 95%. CI = 3.31–5.39, p < 0.001; nonhomogeneous: RR = 21.88, 95%. CI = 16.44–27.81).[9]

    6. Erythroplakia/proliferative verrucous leukoplakia

      Upper: 3 (Erythroplakia/proliferative verrucous leukoplakia)

      Lower: 0 (Other)

      These lesions are considered high-risk for malignant transformation (40–50%). A study by Wadde et al showed that approximately 40 and 9%. cases of oral erythroplakia exhibit mild and moderate dysplasia, respectively, on the first biopsy.[11]

    7. Ulcer with induration/irregular margins

      Upper: 3 (Ulcer with induration or irregular margins)

      Lower: 0 (Other)

      Features such as induration and irregular margins are clinical indicators of malignancy.

    8. Nonhealing ulcers

      Upper: 3 (Nonhealing ulcer for > 3 weeks)

      Lower: 0 (Resolves within 2–3 weeks)

      Persistence without resolution is a clinical red flag, as observed by the Pimenta-Barros et al review.[9]

    Scoring and inference

    The total score guides clinical decision-making:

    Score > 3: Immediate biopsy is recommended. Lesions in this category are considered high-risk.

    Score = 3: A period of two-weekly surveillance is advised after removal of causative agents. If the lesion does not regress, biopsy is indicated.

    Score < 3: Two-monthly surveillance is recommended, with reassessment upon symptom escalation.

    This approach allows for clinical flexibility with a structure based on risk stratification.

Implications for Practice

The OBS is not intended to replace clinical judgment but to complement it. It serves as an adjunctive tool for early detection, helping clinicians in decision-making and promote standardization, thereby reducing variability between clinicians. Moreover, it improves record-keeping, communication, and follow-up processes, particularly valuable in primary care settings where access to specialists may be limited. The strength of the OBS lies in its simplicity. With appropriate training, it can be widely generalized to support frontline health care providers. The scoring system is limited by validation and need real-world data and it also involves interobserver variability but it makes the diagnosis objective and data-friendly. OBS scoring system is designed for treatment-naive oral lesion, thus oral submucous fibrosis and any prior history of oral cavity cancers should be excluded.

Conclusion

The OBS is a novel, practical tool created to assist clinicians in diagnosing OPMD or malignancy through timely biopsy. By combining well-known risk factors into a simple scoring system, the OBS makes it easier to detect oral cancer early. It is strongly recommended to validate the OBS through multicentric prospective studies and real-world database.


Table 1

Oral biopsy score assessment

Upper limit

Lower limit

Tobacco/alcohol/areca nut use

1

0

Size > 2 cm (largest diameter)

1

0

Duration of lesion (> 5 years)

1

0

Located on:

1. Tongue and floor of the mouth (all)

2. Buccal mucosa and bucco-alveolar complex (for abuser)

1

0

Heterogeneous/nonhomogeneous (includes speckled, nodular, verrucous)

2

0

Erythroplakia/proliferative verrucous leukoplakia

3

0

Ulcer with induration/irregular margins

3

0

Nonhealing ulcer for more than 3 weeks

3

0

Inference

Score

Decision

> 3

Biopsy

3

Two-weekly surveillance (after removal of cause, if any. And if there is no improvement in 2 weeks, then biopsy)

< 3>

Two-monthly surveillance (on follow up, action as per score. Reassess sooner if symptoms escalate)

Conflict of Interest

None declared.

Patient Consent

Patient consent is not required.

    References

    1. Warnakulasuriya S, Kujan O, Aguirre-Urizar JM. et al. Oral potentially malignant disorders: a consensus report from an international seminar on nomenclature and classification, convened by the WHO Collaborating Centre for Oral Cancer. Oral Dis 2021; 27 (08) 1862-1880
      Crossref PubMed Search in Google Scholar
    2.  Joshi P, Nair S, Chaturvedi P, Nair D, Agarwal JP, D'Cruz AK. Delay in seeking specialized care for oral cancers: experience from a tertiary cancer center. Indian J Cancer 2014; 51 (02) 95-97
      Crossref PubMed Search in Google Scholar
    3.  van der Waal I. Potentially malignant disorders of the oral and oropharyngeal mucosa; present concepts of management. Oral Oncol 2010; 46 (06) 423-425
      Crossref PubMed Search in Google Scholar
    4.  Home [Internet]. Accessed September 5, 2025 at:  https://monographs.iarc.who.int
    5.  Asthana S, Labani S, Kailash U, Sinha DN, Mehrotra R. Association of smokeless tobacco use and oral cancer: a systematic global review and meta-analysis. Nicotine Tob Res 2019; 21 (09) 1162-1171
      Crossref PubMed Search in Google Scholar
    6.  Gandini S, Botteri E, Iodice S. et al. Tobacco smoking and cancer: a meta-analysis. Int J Cancer 2008; 122 (01) 155-164
      Crossref PubMed Search in Google Scholar
    7.  Singhavi HR, Singh A, Bhattacharjee A, Talole S, Dikshit R, Chaturvedi P. Alcohol and cancer risk: a systematic review and meta-analysis of prospective Indian studies. Indian J Public Health 2020; 64 (02) 186-190
      Crossref PubMed Search in Google Scholar
    8.  Warnakulasuriya S, Chen THH. Areca nut and oral cancer: evidence from studies conducted in humans. J Dent Res 2022; 101 (10) 1139-1146
      Crossref PubMed Search in Google Scholar
    9.  Pimenta-Barros LA, Ramos-García P, González-Moles MÁ, Aguirre-Urizar JM, Warnakulasuriya S. Malignant transformation of oral leukoplakia: systematic review and comprehensive meta-analysis. Oral Dis 2025; 31 (01) 69-80
      Crossref PubMed Search in Google Scholar
    10.  Barfi Qasrdashti A, Habashi MS, Arasteh P, Torabi Ardakani M, Abdoli Z, Eghbali SS. Malignant transformation in leukoplakia and its associated factors in Southern Iran: a hospital based experience. Iran J Public Health 2017; 46 (08) 1110-1117
      PubMed Search in Google Scholar
    11.  Wadde KR, Gajare PP, Sachdev SS, Singhavi HR. Prevalence and malignant transformation rate of oral erythroplakia worldwide - a systematic review. Ann Maxillofac Surg 2024; 14 (01) 76-80
      PubMed Search in Google Scholar

We recommend

    References

    1. Warnakulasuriya S, Kujan O, Aguirre-Urizar JM. et al. Oral potentially malignant disorders: a consensus report from an international seminar on nomenclature and classification, convened by the WHO Collaborating Centre for Oral Cancer. Oral Dis 2021; 27 (08) 1862-1880
      Crossref PubMed Search in Google Scholar
    2.  Joshi P, Nair S, Chaturvedi P, Nair D, Agarwal JP, D'Cruz AK. Delay in seeking specialized care for oral cancers: experience from a tertiary cancer center. Indian J Cancer 2014; 51 (02) 95-97
      Crossref PubMed Search in Google Scholar
    3.  van der Waal I. Potentially malignant disorders of the oral and oropharyngeal mucosa; present concepts of management. Oral Oncol 2010; 46 (06) 423-425
      Crossref PubMed Search in Google Scholar
    4.  Home [Internet]. Accessed September 5, 2025 at:  https://monographs.iarc.who.int
    5.  Asthana S, Labani S, Kailash U, Sinha DN, Mehrotra R. Association of smokeless tobacco use and oral cancer: a systematic global review and meta-analysis. Nicotine Tob Res 2019; 21 (09) 1162-1171
      Crossref PubMed Search in Google Scholar
    6.  Gandini S, Botteri E, Iodice S. et al. Tobacco smoking and cancer: a meta-analysis. Int J Cancer 2008; 122 (01) 155-164
      Crossref PubMed Search in Google Scholar
    7.  Singhavi HR, Singh A, Bhattacharjee A, Talole S, Dikshit R, Chaturvedi P. Alcohol and cancer risk: a systematic review and meta-analysis of prospective Indian studies. Indian J Public Health 2020; 64 (02) 186-190
      Crossref PubMed Search in Google Scholar
    8.  Warnakulasuriya S, Chen THH. Areca nut and oral cancer: evidence from studies conducted in humans. J Dent Res 2022; 101 (10) 1139-1146
      Crossref PubMed Search in Google Scholar
    9.  Pimenta-Barros LA, Ramos-García P, González-Moles MÁ, Aguirre-Urizar JM, Warnakulasuriya S. Malignant transformation of oral leukoplakia: systematic review and comprehensive meta-analysis. Oral Dis 2025; 31 (01) 69-80
      Crossref PubMed Search in Google Scholar
    10.  Barfi Qasrdashti A, Habashi MS, Arasteh P, Torabi Ardakani M, Abdoli Z, Eghbali SS. Malignant transformation in leukoplakia and its associated factors in Southern Iran: a hospital based experience. Iran J Public Health 2017; 46 (08) 1110-1117
      PubMed Search in Google Scholar
    11.  Wadde KR, Gajare PP, Sachdev SS, Singhavi HR. Prevalence and malignant transformation rate of oral erythroplakia worldwide - a systematic review. Ann Maxillofac Surg 2024; 14 (01) 76-80
      PubMed Search in Google Scholar

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