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Efficacy and safety of topical tocopherols in oral biopsies

Comparative efficacy of tocopherol (VEA film os) versus chlorhexidine in patients undergoing oral biopsies: a randomized case-control study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN11647292
Enrollment
60
Registered
2023-05-09
Start date
2023-02-28
Completion date
Unknown
Last updated
2024-09-23

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

Conditions

Oral lesions Oral Health

Interventions

Current interventions as of 10/09/2024: Patients with oral lesions requiring biopsy will be recruited. One group (control) receive standard of care i.e. chlorhexidine while the second group (case) r

Sponsors

HULKA srl
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients undergoing biopsy of the oral cavity at the UOC Dental Clinic 2. Patients able to read and understand the information sheet and give informed consent 3. Patients who, after having been informed in detail about how to use Vea Filme os, have complied with the intake schedule

Exclusion criteria

Exclusion criteria: Current inclusion criteria as of 10/09/2024: 1. Patients with contraindications to surgery 2. Patients unable to give consent 3. Minor patients 4. Patients receiving antiangiogenic therapy 5. Patients receiving immunomodulator therapy 6. Patients with hypersensitivity to the Vea Filme os device _____ Previous exclusion criteria: 1. Patients with contraindications to surgery 2. Patients unable to give consent 3. Patients who took painkillers during the six study days 4. Minor patients 5. Patients receiving antiangiogenic therapy 6. Patients receiving immunomodulator therapy 7. Patients with hypersensitivity to the Vea Filme os device

Design outcomes

Primary

MeasureTime frame
Discomfort measured using a pain-related visual analog scale (VAS) on days 1 and 6

Secondary

MeasureTime frame
Complications recorded by interviewing the patient after 1 and 6 days

Countries

Italy

Outcome results

None listed

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