Oral Lichen Planus, Oral Lichen Planus Related Stress
Conditions
Keywords
treatment, saliva stress, oral lichen planus
Brief summary
Lichen planus, a chronic autoimmune mucocutaneous disorder, affects 0.5% to 2.2% of diverse populations. The treatment for oral lichen planus (OLP) includes a range of options, both topical and systemic therapies. Recent research has highlighted the potential of hyaluronic acid as a drug alternative, potentially offering effective management for OLP and alleviating the discomfort of this chronic condition. The objective was to assess the impact of topical hyaluronic acid on salivary oxidative stress markers in individuals suffering from oral lichen planus
Detailed description
Interventional (Clinical Trial) Actual Enrollment : 60 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Care Provider, Outcomes Assessor) Masking Description: The clinical outcomes were assessed by an investigator masked about the treatment modality that has been used Primary Purpose: Treatment Pain , quality of life the study on oral lichen planus, three treatment groups were established: Group I: Received a combination of 0.1% hyaluronic acid and 0.2% triamcinolone acetonide. Group II: Was treated solely with 0.2% triamcinolone acetonide. Group III: Received only 0.1% hyaluronic acid. These groups were designed to evaluate and compare the efficacy of different treatments in patients with oral lichen planus.
Interventions
COMBINATION_PRODUCTAcetonide triamcinolone 0.2% +hyaluronicacid 1%
topical application cream form twice a day for 4 weeks
DRUGCorticoid Acetonide triamcinolone 0.2%
topical application cream form twice a day for 4 weeks
DRUGHyaluronic acid 1%
topical application cream form twice a day for 4 weeks
Sponsors
Pia Lopez Jornet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Randomization: The enrolled subjects were randomly assigned to one of two treatment protocols using a computer-generated table. This method ensures impartial allocation and avoids biases in treatment selection for each patient. Masking: Medications were prepared and packaged in identical, sealed, and numbered envelopes by the hospital pharmacy and a clinician not involved in the subsequent phases of the study. Each sealed envelope contained the protocol assignment for individual patients and written instructions for the application of the medications. Moreover, clinicians involved in treatment evaluation at each follow-up session were blinded to the treatment assigned to each patient.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with diagnosis oral lichen planus. Patients with no history of taking corticosteroids for the last 6 months Patients who agrees to take medication.
Exclusion criteria
Pregnant and lactating ladies. Patients with recent dental filling associated with the lesion or associated with recent drug administration. Patient with uncontrolled diabetes, uncontrolled hypertension,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain assessment scale | 4 weeks | visual analog scale (VAS) score 0-10 higher scores mean a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OHIP-14 questionnaire | 4 weeks | evaluate the oral health related quality of life score 0-56 higher scores mean a worse outcome |
| reduction of clinical signs measure | 4 weeks | Thongprasom Score 5 = white striae with erosive area = 1 cm2 Score 4 = white striae with erosive area \< 1 cm2 Score 3 = white striae with erosive area \> 1 cm2 Score 2 = white striae with atrophic area \< 1 cm2 Score 1 = mild white striae only Score 0 = no lesion normal |
| Salivary level of oxidative stress biomarker | 4 weeks | Salivary level of oxidative stress biomarker Amilase; Glutation, IgA, FRAP, ADA |
Countries
Spain
Outcome results
None listed