Comparative evaluation of salivary flow rate in Oral Submucous Fibrosis patients before and after Transcutaneous Electric Nerve Stimulation
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Significant increase in salivary flow rate after Transcutaneous Electric Nerve Stimulation in Oral Submucous Fibrosis patients
Study Overview
Brief Summary
Introduction- A persistent, precancerous, and frequently debilitating condition - oral submucous fibrosis is characterized by a slowly progressing fibrosis of the oropharynx and oral cavity. Reduction in salivary flow is one of the common symptom experienced by the sufferer. Using electric current to stimulate nerves, Transcutaneous Electric Nerve Stimulation (TENS) for improving salivation serves as a simple, affordable, and non-invasive method. TENS can decrease the discomfort due to long-lasting hyposalivation.
Need of the study- Although the effectiveness of TENS on salivary flow rate is studied in number of conditions, the evidence/ studies describing the effect of TENS on salivary flow rate in oral sub mucus fibrosis patients is not found. This contemplated the intention of the present study.
Aim- To evaluate and compare salivary flow rate in oral submucous fibrosis patients before and after transcutaneous electric nerve stimulation.
Materials and method- This protocol for prospective research study will be undertaken at Sharad Pawar Dental College, Department of Oral Medicine and Radiology in the state of Maharashtra, in India, from February 2024 to January 2025. Patients between the age group of the 18– 45 years and suffering from Oral Submucous Fibrosis and evaluated on basis of Inventory of Xerostomia (XI) questionnaire to have reduced salivation will be included. The Modified Schirmer test (MST) will be used to evaluate salivary flow rate before and after TENS therapy. All the findings will be recorded in a tabular format and are subjected to appropriate statistical tests to evaluate the statistical significance regarding the improvement in salivary flow rate.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients between age group of 18-45 years will be included in the study.
- •Individuals with clinically established stages of OSMF with burning sensation, limited mouth opening, palpable fibrous bands.
- •Patients giving history of decreased salivation for a duration of more than 6 months.
- •Clinical examination revealed hyposalivation due to habit induced OSMF will be included in the study group.
Exclusion Criteria
- •The study excludes patients undergoing treatment for Oral Submucous Fibrosis, those with any salivary gland disorder, whether they are currently on medication for it or not.
- •Additionally, individuals with a history of stress, systemic conditions or diseases likely to decrease salivation, radiation therapy, mental illness, oral mucosal lesions, and denture wear are excluded.
- •Moreover, participants using medications that could affect salivary parameters, such as diuretics, anticholinergics, antihistamines, antihypertensives, and psychotropic substances, are not considered.
- •Those with prolonged habits of smoking and alcohol consumption are also excluded from the study.
Outcomes
Primary Outcomes
Significant increase in salivary flow rate after Transcutaneous Electric Nerve Stimulation in Oral Submucous Fibrosis patients
Time Frame: Assessment will be done at 2 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Tanaya Teredesai
Datta Meghe Institute of Higher Education and Research