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Endoscopic Assisted Platysma Flap Surgery

Evaluation of Non-Endoscopic and Endoscopic assisted Platysma flap- A Randomised control trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056506
Enrollment
40
Registered
2023-08-16
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: K135- Oral submucous fibrosis Health Condition 2: K135- Oral submucous fibrosis

Interventions

Intervention1: Endoscopic assisted Platysma flap for reconstruction in surgical treatment of OSMF patient: Endoscopic assisted Platysma flap for reconstruction after fibrotomy in surgical treatment of

Sponsors

KING GEORGES MEDICAL UNIVERSITY
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -Patient willing to participate in the study -Grade III and Grade IV oral submucous fibrosis -Patient willing to leave tobacco chewing habit and promised to do so after operation

Exclusion criteria

Exclusion criteria: -Patients not willing -Age > 60 years (patient with thin platysma) -patient is not willing to quit the tobacco chewing habit. (non-cooperative patients) -Advanced disease with premalignant and malignant changes -Patient with prior neck incisions, previous radiotherapy. -Generalized fibromatosis -Oral manifestation of scleroderma -Pale oral mucosa of anemia mimicking blanching -Chronic debilitating conditions such as DM, HT, HIV etc.

Design outcomes

Primary

MeasureTime frame
Improved Mouth opening, improved speech, masticationTimepoint: 4 week

Secondary

MeasureTime frame
Improvement in Esthetics Improvement in function (speech, mastication. Improvement in oral hygieneTimepoint: day of operation, 3rd day, 1 week, 15day, months, 3 months, 6 months

Countries

India

Contacts

Public ContactDr Sandeep Kumar

King Georges Medical University,Lucknow

uspal@kgmcindia.edu9415006417

Outcome results

None listed

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