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Abdominal Dermal Fat Graft versus Nasolabial Flap as Graft in Surgical Management of Advanced Oral Submucous Fibrosis

Comparison of Abdominal Dermal Fat Graft with Nasolabial Flap as Graft in Surgical Management of Advanced Oral Submucous Fibrosis- A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/063202
Enrollment
34
Registered
2024-02-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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: Abdominal dermal fat graft: Reconstruction of fibrotomy defect with abdominal dermal fat graft in a single surgery under general anesthesia (3-4 hours) and then patient will be followed

Sponsors

Dr Mehak Kataria
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with OSMF Grade 3 and 4A 2. Patients in whom diagnosis is confirmed clinically 3. Patient with mouth opening equal to or less than 15mm. 4. Good general health status. 5. Patient with good oral hygiene and motivation.

Exclusion criteria

Exclusion criteria: 1. Patients with OSMF Grade 1, 2 and 4B 2. Patients with presentation of any other cause of trismus. 3. Medically compromised patients (ASA class III and IV) 4. Unable to come for follow up visits 5. Not willing to quit deleterious habits.

Design outcomes

Primary

MeasureTime frame
Interincisal mouth openingTimepoint: preoperatively, and postoperatively and at 6 months

Secondary

MeasureTime frame
Quality of lifeTimepoint: preoperatively and postoperatively at 6 months;Donor site morbidity Timepoint: post operatively at 6 months;Ease of surgeryTimepoint: postoperatively;Graft uptake Timepoint: post operatively at 6 months;Lower facial heightTimepoint: preoperatively and post operatively at 6 months;Surgical time of the procedureTimepoint: from first incision till the placement of last suture

Countries

India

Contacts

Public ContactDr Mehak Kataria

Government Dental College and Hospital, Nagpur

varshamanekar67@gmail.com9823077626

Outcome results

None listed

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