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To study the effects of steroid injections in fibrosis of oral mucosa using polarising microscope ââ?¬â?? A prospective study

To evaluate the effects of intralesional steroid in Oral submucous fibrosis using polarising microscope ââ?¬â?? A prospective study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/04/032843
Enrollment
52
Registered
2021-04-15
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: D000- Carcinoma in situ of lip, oral cavity and pharynx Health Condition 2: K135- Oral submucous fibrosis

Interventions

Intervention1: 1. incisional biopsy 2. intralesional injection: Patients clinically diagnosed as grade 2 and grade 3 Oral submucous fibrosis visiting Department of Oral and Maxillofacial surgery and D

Sponsors

Govt Dental College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients clinically diagnosed as Grade 2 and Grade 3 Oral submucous fibrosis. 2. Individuals with no underlying systemic disease 3. Individuals ready for the study procedure and who will give written consent to undergo the study willingly .

Exclusion criteria

Exclusion criteria: 1. Patients suffering from systemic conditions such as diabetes, hypertension, bleeding disorders, thyroid disorders 2. Patients allergic to steroids. 3. Patients with trismus but no palpable fibrous bands. 4. Patients unwilling to undergo the study and do not give informed written consent

Design outcomes

Primary

MeasureTime frame
1. To measure the improvement in clinical mouth opening after intralesional steroidal treatment 2. To check the efficacy of Triamcinolone acetamide with Hyaluronic acid in treatment of oral submucous fibrosis.Timepoint: 9 months

Secondary

MeasureTime frame
1. To investigate the types collagen fibers among different grades of oral submucous fibrosis 2. To compare the difference in pattern of distribution, types and color profile of collagen fibers before and after giving intralesional steroids in oral submucous fibrosis. 3. To compare the effectiveness of picrosirius red stain under polarizing microscopy with routine microscopy for evaluation of the collagen parameters such as types, orientation and color profile.Timepoint: 9 months

Countries

India

Contacts

Public ContactDr Varthangpuii

GOVERNMENT DENTAL COLLEGE AND HOSPITAL, MUMBAI

prajwalitkende1979@gmail.com9324715824

Outcome results

None listed

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