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A randomized controlled trial on surgical intervention vs standard care of dysplatic oral leukoplakias.

Efficacy of surgical excision of dysplastic oral leukoplakia: A Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050347
Enrollment
362
Registered
2023-03-03
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K132- Leukoplakia and other disturbancesof oral epithelium, including tongue

Interventions

Intervention1: Group I: Surgical excision of the lesion in patients with single oral white patch and with prior diagnosis of epithelial dysplasia on incisional biopsy. The surgical removal of the lesi

Sponsors

RIMS, Ranchi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a) Clinical diagnosis of Oral Leukoplakia (Homogenous and non-homogenous); b) Gender: All eligible for study c) Lesion size: 2 cm maximum longitudinal size of the single lesion. d) Lesions’ location: Oral areas with no surgical risk of damages to important anatomical structures such as nerves, salivary ducts and/or arteries. e) Histopathological diagnosis of epithelial dysplasia on incisional biopsy.

Exclusion criteria

Exclusion criteria: a) Presence of histological signs of oral lichen planus, on the basis of WHO criteria, b) Presence of clinical and histological signs of proliferative verrucous leukoplakia, on the basis of the 2010 and 2013 classifications; c) Presence of white lesions on the lip vermillion; d) Incapacity to understand verbal and written instructions; e) Pregnant or breast-feeding women; f) Previous or current diagnosis of oral squamous cell carcinoma.

Design outcomes

Primary

MeasureTime frame
Oral cancer development in the same place of the primary disease as confirmed by histopathological examination.Timepoint: 6 months

Secondary

MeasureTime frame
1) Safety of the intervention, as measured by the incidence of severe adverse effects 2) Clinical fading (in GROUP I: incidence of recurrences or new lesion; in GROUP II: clinical worsening of the primary lesions or recurrence of new lesions).Timepoint: 6 months

Countries

India

Contacts

Public ContactDr Ankita Tandon

Dental College, RIMS, Ranchi

drankitatandon7@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026