Lugol’s Iodine in surgical management of epithelial dysplasia in the oral cavity and oropharynx

A multi-centre, randomised controlled trial assessing the effectiveness of Lugol's Iodine in Surgical managemenT of Epithelial dysplasia in the oRal cavity and oropharynx

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11348079

Enrollment

Registered

2016-04-01

Start date

2015-12-01

Completion date

Unknown

Last updated

2022-08-22

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

Conditions

Epithelial dysplasia in the oral cavity and oropharynx Cancer

Interventions

1. Standard Treatment Group: Surgical excision of epithelial dysplasia as per usual practice 2. Intervention Treatment Group: Surgical excision of epithelial dysplasia assisted by visu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Provision of written informed consent 2. Age= 18 years old 3. Epithelial dysplasia of the oral cavity or oropharynx, undergoing primary surgical excision under general anaesthesia

Exclusion criteria

Exclusion criteria: 1. Previous surgery or radiotherapy for head and neck cancer 2. Allergy to iodine 3. Previous diagnosis of head & Neck SCC in the past 5 years or active malignancy within 2 years of randomisation (except basal cell carcinoma or carcinoma of the cervix in-situ)

Design outcomes

Primary

Measure	Time frame
Rates of surface dysplasia or carcinoma-in-situ at surface mucosal margins	—

Secondary

Measure	Time frame
1. Two-year incidence of histologically confirmed transformation to SCC in the oral/cavity/oropharynx 2. Occult SCC diagnosed histopathologically in excised mucosa 3. Surface area of mucosa excised 4. Extent of margin clearance in mm 5. Surgeon decision to re-excise at the same site following positive margins 6. Estimate of the two year recurrence rates of oral dysplasia 7. Acceptability of the technique to surgeons (intervention treatment group) 8. Safety of the technique (intervention treatment group) 9. Assessment of Quality of Life changes	—

Measure

Time frame

1. Two-year incidence of histologically confirmed transformation to SCC in the oral/cavity/oropharynx 2. Occult SCC diagnosed histopathologically in excised mucosa 3. Surface area of mucosa excised 4. Extent of margin clearance in mm 5. Surgeon decision to re-excise at the same site following positive margins 6. Estimate of the two year recurrence rates of oral dysplasia 7. Acceptability of the technique to surgeons (intervention treatment group) 8. Safety of the technique (intervention treatment group) 9. Assessment of Quality of Life changes

—

Countries

England, Scotland, United Kingdom

Contacts

Public ContactJacqueline Quantrill

jacqueline.quantrill@bthft.nhs.uk+44 1274 383921

Outcome results

None listed

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