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Study comparing accuracy of two stains to mark extent of abnormal cancerous cells for better visibility during complete removal of mouth lesions.

Diagnostic efficacy of Lugolâ??s iodine vs Double vital staining to demarcate Surgical Margins using Immunohistochemistry in Oral Potentially Malignant Disorders & Squamous Cell Carcinoma: A Prospective, Randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/04/018537
Enrollment
34
Registered
2019-04-10
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: Lugols Iodine stain: Only Lugols Iodine stain will be used in Group A to delineate the extent of dysplastic/Cancerous lesion before surgical excision Control Intervention1: Double vital

Sponsors

Dr Gaurav Bhatia
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients of age 18 years or above. 2) â??Oral potentially malignant disorders(OPMDs)â?? according to WHO 2017 classification. 3) Early malignant lesions i.e. Stage 1 SCC. 4) Planned for primary surgical treatment with curative intent. 5) FOR Immunohistochemistry(IHC): Wide local excision biopsy with mucosal surgical margins>=5 mm on histopathological examination.

Exclusion criteria

Exclusion criteria: 1) Previous surgery, chemotherapy or radiotherapy for head and neck cancer. 2) Allergy to iodine or Toluidine blue stains. 3) Metastatic disease (except a single regional lymph node with no extracapsular spread.) 4)Patients in whom the surgical margins of the excision biopsy cannot be defined. 5)FOR Immunohistochemistry(IHC): Wide local excision biopsy specimens with surgical margins that show dysplasia, carcinoma in situ and are positive( 6) Pregnancy and lactating mothers. 7) Patients under 18 years of age.

Design outcomes

Primary

MeasureTime frame
To assess and compare the how many of the surgical margins free of tumour with routine Histopathological examination show positivity with p53( Immunohistochemistry) analysis in Group A & B patients.Timepoint: At Immunohistochemistry analysis, after histopathological examination.—

Secondary

MeasureTime frame
To assess and compare sensitivity and specificity of Lugols iodine stain versus Double vital staining method in identifying dysplastic and cancerous cellsTimepoint: at Histopathological examination of resected specimen—

Countries

India

Contacts

Public ContactDr Vinod Thangaswamy

Coorg Institute of Dental Sciences

svinodthangaswamy@gmail.com9791642614

Outcome results

None listed

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