Skip to content

Assessment of Salivary Biomarkers (Lactate Dehydrogenase, Matrix Metalloproteinase-9, and Ferritin) in Patients with Oral Submucous Fibrosis: A Randomized Controlled Study

EVALUATION OF SALIVARY BIOMARKERS: LACTATE DEHYROGENASE, MATRIX METALLOPROTEINASE-9, FERRITIN IN PATIENTS WITH ORAL SUBMUCOUS FIBROSIS A RANDOMIZED CONTROLLED STUDY - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/111345
Enrollment
60
Registered
2026-05-29
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: Z758- Other problems related to medicalfacilities and other health care

Interventions

Intervention1: Collection and evaluation of salivary biomarkers in OSMF: Participants diagnosed with Oral Submucous Fibrosis will receive standard treatment according to clinical stage, including anti

Sponsors

Prin . K M Kundani College of Pharmacy
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged between 18 and 65 years. Individuals with a history of deleterious oral habits. Patients with clinically diagnosed cases of Oral Submucous Fibrosis of all grades. Patients classified as ASA I and ASA II will be included. Patients willing to participate in the study and provide written informed consent.

Exclusion criteria

Exclusion criteria: Patients with Scleroderma, amyloidosis, Iron deficiency Anaemia, lesions superimposing OSMF and those disease altering the levels of salivary biomarkers. Patients with trismus due to disease other than OSMF. History of prior surgical treatment, radiotherapy and chemotherapy for OSMF or Cancer. Pregnant or lactating women. Patients on iron supplements. Patients on corticosteroid therapy. Patients belonging to ASA III and ASA IV classification. Patients with history of trauma. Patients with TMJ disorders. Patients unwilling to provide consent or comply with follow-up protocols.

Design outcomes

Primary

MeasureTime frame
Assessment and comparison of salivary biomarker levels among OSMF patients, habit-associated individuals without OSMF, and healthy controlsTimepoint: For OSMF Patients- Baseline and 1 month post treatment. For habit associated - baseline For healthy controls - baseline

Secondary

MeasureTime frame
Correlation of salivary biomarker levels with clinical staging/severity of OSMF Association between duration/frequency of deleterious habits & salivary biomarker levels Comparison of biomarker levels between habit-associated individuals & healthy controls Evaluation of salivary biomarkers as potential indicators of disease progressionTimepoint: For osmf - baseline & one month post treatment For habit associated individuals - baseline For healthy individuals - baseline

Countries

India

Contacts

Public ContactDr Urvi Gohil

Government Dental College , Mumbai

dr.kavitawadde@gmail.com9004799405

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026