A HOSPITAL BASED STUDY TO COMPARE THE EFFICACY OF LYCOPENE AND SERRATIOPEPTIDASE IN THE MANAGEMENT OF ORAL SUBMUCOUS FIBROSIS

A Hospital-Based Experimental Prospective Study To Compare The Efficacy Of Lycopene And Serratiopeptidase In The Management of Oral Submucous Fibrosis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/12/047901

Enrollment

Registered

2022-12-06

Start date

Unknown

Completion date

Unknown

Last updated

2023-01-09

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: SERRATIOPEPTIDASE: FIBRINOLYTIC (PROTEOLYTIC ENZYME) Dose - 10 mg thrice daily for 4 weeks Route- Oral Control Intervention1: LYCOPENE: ANTIOXIDANT Dose - 8 mg twice daily for 4 weeks R

Eligibility

Inclusion criteria

Inclusion criteria: For establishment of oral submucous fibrosis diagnosis, two parame-ters mentioned below were to be satisfied for inclusion in the pre-sent study- (a) Positive history of chewing areca nut or one of its commercial preparations, difficulty in swallowing and chewing and burning sen-sation on eating spicy foods. (b) Restricted mouth opening and changes in the oral mucous mem-brane including the presence of palpable vertical fibrous bands, stiffness and blanching.

Exclusion criteria

Exclusion criteria: Individuals with other associated oral mucosal lesions or systemic diseases, systemic conditions like pregnancy, lactating mother and those not willing for follow-up.

Design outcomes

Primary

Measure	Time frame
The outcome of both the drugs will be comparedTimepoint: 4 weeks	—

Secondary

Measure	Time frame
1.The OSMF will be graded clinically according to the classification of Ranganathan et al 2.The mouth opening will be measured with a Vernier Caliper between the incisal tips of both the arches 3.Burning sensation will be gauged based on Visual Analogue Scale ranging from 0- 10 4.The degree of protrusion of tongue will be recorded in millimeters from the incisal edge of the lower teeth to the tip of tongue. 5.Palpatory findings will be recorded as positive when a lack of suppleness and palpable fibrous bands or marked stiffness will be evident for the areas of the right and left buccal mucosa, lips and floor of mouth. 6.The site of the bands and its extent (including segmentation) in all the groups will be recorded at the initial visit and later compared with weekly interval using the criteria: 1 as Improved, 0 no change and -1 as worsen Timepoint: Recalled every week for 4 Weeks	—

Measure

Time frame

1.The OSMF will be graded clinically according to the classification of Ranganathan et al 2.The mouth opening will be measured with a Vernier Caliper between the incisal tips of both the arches 3.Burning sensation will be gauged based on Visual Analogue Scale ranging from 0- 10 4.The degree of protrusion of tongue will be recorded in millimeters from the incisal edge of the lower teeth to the tip of tongue. 5.Palpatory findings will be recorded as positive when a lack of suppleness and palpable fibrous bands or marked stiffness will be evident for the areas of the right and left buccal mucosa, lips and floor of mouth. 6.The site of the bands and its extent (including segmentation) in all the groups will be recorded at the initial visit and later compared with weekly interval using the criteria: 1 as Improved, 0 no change and -1 as worsen Timepoint: Recalled every week for 4 Weeks

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Countries

India

Contacts

Public ContactKriti Shrivastava

Rishiraj College Of Dental Sciences And Research Centre

drkshrivastava11@gmail.com9425693111

Outcome results

None listed

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