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Comparison of Diode laser compared to CO2 laser in the management of leukoplakia

Effectiveness of Diode laser compared to CO2 laser in the treatment of leukoplakia-A Non- Inferiority Randomized control trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/01/048764
Enrollment
142
Registered
2023-01-05
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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: A Diode Laser with a 980nm wavelength (Ga-Al-As) (DILAS, Germany) (Model: IndiLase, manufactured by MEDSOL, Hosur, India)with an output power of 2.0 -4-0 W and a flexible 400um diameter
depending on the extent of the lesion, on an average, the energy transmitted to the tissue will be on average 1600 J per surface unit (cm2). Complete aseptic conditions will be maintained and both pat

Sponsors

All India institute of medical sciences Patna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients diagnosed clinically and histopathologically with no dysplasia and mild of moderate dysplasia. Oral Leukoplakia aged between 20 to 70 years, irrespective of the gender, Patient with history of tobacco chewing and those who are willing to undergo laser therapy. Patients with persistent lesion even after 1 month of counseling and tobacco cessation. Patient ready to quit habit. Patient ready for biopsy

Exclusion criteria

Exclusion criteria: Patients having severe dysplasia confirmed by histopathologically. Patients with history of any systemic disease or disorders Patients who fail to give written consent Histopathological severe dysplastic changes. Lesions regressed with antifungal agent will be excluded from the study. Lesions with no history of tobacco/ Idiopathic leukoplakia

Design outcomes

Primary

MeasureTime frame
The objectives of the study is to compare the effectiveness (Pain, edema, infection, scar, healing pattern and recurrence rate) of Diode laser compared to CO2 laser for the treatment of leukoplakia.Timepoint: Details of duration and outcome measure are as follows- 2nd day-Pain, Healing pattern. 1 week-Pain, Healing pattern 2 week-Pain, Healing pattern 1 month-Healing pattern, Scarring 3 months-Recurrences. 6 months-Recurrences.—

Secondary

MeasureTime frame
not applicableTimepoint: 00—

Countries

India

Contacts

Public ContactPeeyush Shivhare

All India institute of medical sciences, Patna

textbookoforalmedicine3@gmail.com7759971076

Outcome results

None listed

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