Comparison of efficiency of combination of placental extract with steroid and combination of hynidase with steroid for treating fibrosis and reduced mouth opening caused due to oral submucous fibrosis.

Comparative clinical and ultrasonographic evaluation of the efficiency of Placentrex with Dexamethasone & Hyaluronidase with Dexamethasone in the treatment of Oral Submucous Fibrosis- A randomized Control Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/05/013843

Enrollment

Registered

2018-05-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Clinically Diagnosed cases of Oral Submucous Fibrosis

Interventions

Intervention1: Hyaluronidase(1500IU/2ml)marketed under the name Hynidase, Dexamethasone(4mg/ml) marketed under the name dexona, SM Fibro Capsules: Group B:Weekly intralesional injection of combinati

Eligibility

Inclusion criteria

Inclusion criteria: 1)Individuals clinically diagnosed with Oral Submucous Fibrosis with palpable bands in the oral cavity 2)OSMF patients with mouth opening greater than 25mm 3)Individuals with willingness to quit the habit that caused the disease 4)Individuals willingly consenting to take part in the study 5)No previous history of treatment for oral submucous fibrosis 6)no other concurrent oral lesions

Exclusion criteria

Exclusion criteria: 1)Patients who are unwilling to quit the habit that caused the disease. 2)Patients unwilling to consent for the study. 3)Previously treated Oral Submucous Fibrosis. 4)Currently under treatment for Oral Submucous Fibrosis. 5)Presence of other concurrent oral premalignant lesions. 6)Health status which makes the patient not a feasible candidate for the trial.

Design outcomes

Primary

Measure	Time frame
Improvement in mouth opening in Group A(placental extract+Dexamethasone) is expected to be about 3.5mm in 8 weeks In group B (Hyaluronidase+Dexamethasone) an improvement of mouth opening by about 3.7mm is expected at the end of 8 weeksTimepoint: 8 weeks	—

Secondary

Measure	Time frame
Improvement in subjective symptoms of burning sensation by 5.2 points expected in Group A and 4.9 poits expected in Group B respectively at the end of 8 weeksTimepoint: 8 weeks	—

Countries

India

Contacts

Public ContactDr Sosa George

Meenakshi Ammal Dental College

dr.saraswathik@yahoo.co.in9443291115

Outcome results

None listed

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