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Comparision of Triamcinolone acetonide and Placentrex in treatment of reduced mouth opening

Comparative Efficacy of Intralesional Placental Extract and Intralesional Triamcinolone acetonide in the Management of Oral Submucous Fibrosis.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/08/020719
Enrollment
40
Registered
2019-08-14
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: K135- Oral submucous fibrosis

Interventions

Intervention1: Human Aqueous Placental Extract: Intralesional injection of 2ml Human Aqueous Placental Extract (Placentrex) mixed with 1ml Lignocain on affected buccal mucosa at weekly intervals for a

Sponsors

Christopher Vinay Shinde
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient with clinically diagnosed OSMF. 2. Patient who have not undergone any treatment for OSMF in past. 3. Patients who are willing to quit the gutka, arecanut and or tobacco chewing habit. 4. Patient who are ready to attend regular follow-ups.

Exclusion criteria

Exclusion criteria: 1. Patient who have previously undergone treatment for OSMF. 2. Patient with coexisting systemic illness. 3. Patient with any such coexisting disease or disorder of orofacial region which may interfere with the study protocol.

Design outcomes

Primary

MeasureTime frame
1. Burning sensation on VAS. 2. Pain on VAS. 3. Mouth opening. Timepoint: every week above parameters will be measured(from start of study to the end of study period at weekly intervals)

Secondary

MeasureTime frame
1. Cheek flexibility. 2. Tongue protrusion.Timepoint: weekly i.e., every 7th day

Countries

India

Contacts

Public ContactChristopher Vinay Shinde

peoples college of dental sciences and research centre,bhopal

drnisheethsaawarn@gmail.com09039380088

Outcome results

None listed

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