Atrophic Lichen Planus, Erosive Oral Lichen Planus
Conditions
Brief summary
The goal of this clinical trial is to assess Honey in orabase (1:1) for treating patients with OLP and improving their quality of life: The research question aims to answer: Does honey in orabase (1:1) improve or reduce OLP symptoms compared to the standardized treatment by triamcinolone acetonide 0.1% drug and improve the patient's quality of life? Participants will: Take drug ABC or a placebo every day for 4 months Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their symptoms and the number of times they use a rescue inhaler
Detailed description
The study comprised 56 patients diagnosed with Oral Lichen Planus, who were randomly selected according to inclusion and exclusion criteria. The subjects were between 35 and 60 years old, capable of complying with the study procedure, and provided informed consent. Exclusion criteria encompassed those with alternative oral mucosal illnesses, systemic problems influencing OLP or wound healing, allergies or sensitivities to honey or triamcinolone, or those receiving systemic corticosteroids or immunosuppressive drugs. Individuals who were pregnant or lactating, as well as those unable to provide informed written consent, were excluded.
Interventions
DRUGHoney in orabase 1: 1 paste
The experimental drug was manufactured and packed at the Faculty of Pharmacy, Price Sattam University, SA. Production of a mucoadhesive paste involves a step-by-step process. in the final step, honey, comprising 50% of the total composition was thoroughly blended with the prepared base to ensure homogeneity
Sponsors
Dar Al Uloom University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
This was a double-blind, parallel-group clinical trial. Both participants and outcome assessors were blinded to the intervention. The honey in orabase and triamcinolone formulations were prepared to appear similar in color, texture, and packaging to ensure concealment. Identical containers were used for both treatments, and labeling was done using coded identifiers maintained by a third party not involved in the assessment or data analysis. Participants were instructed to apply the provided formulation as directed without being informed of the specific treatment assignment.
Intervention model description
* Zα/2=1.96=1.96 (for 95% confidence) * Zβ=1.28 (to 90% power) * SD=196 * Δ=1.33 N≈55.65 N=56 56 patients diagnosed with Oral Lichen Planus, randomly assigned to one of the 2 groups
Eligibility
Sex/Gender
ALL
Age
35 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients with a clinical diagnosis of oral lichen planus * Symptomatic OLP lesions (erosive/atrophic) * Participants are between 35 and 60 years old, who are able to adhere to the study protocol, and sign informed consent.
Exclusion criteria
* Patients with other oral mucosal disorders, or systemic conditions influencing OLP or wound healing, allergies or hypersensitivity to honey or triamcinolone * Patients who administer systemic corticosteroids or immunosuppressive agents. * Pregnancy or lactation * Inability to comprehend or adhere to study directives * Patients who are not able to sign an informed written consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Assessment of OLP lesions using OLP score | baseline to 1 year | will be assessed by OLP score: Thongprasom et al.: score 0 (no lesions), score 1 (mild white striae only with no erythematous areas), score 2 (white striae exhibiting an atrophic area \< 1 cm2), score 3 (white striae alongside an atrophic area ≥ 1 cm2), score 4 (white striae in an erosive area \< 1 cm2), and score 5 (white striae alongside an erosive area ≥1 cm2). Atrophic OLP was defined as thinning of the oral mucosa, with a smooth red appearance, while erosive OLP involved ulceration and erosion of the mucosal surface. |
| Pain assessment using Visual analogue scale (VAS) | baseline- to 1 year | (VAS) is a self-reported score typically consisting of a 10 cm horizontal line from right (best) to left (worst) with verbal descriptions (word anchors: 0 cm: No pain; 1 cm: Hardly notice pain; 2 cm: Notice pain does not interfere with activities; 3 cm: Sometimes distracts me; 4 cm: Distracts me, can do usual activities; 5 cm: Interrupts some activities; 6 cm: Hard to ignore, avoid usual activities; 7 cm: focus of attention, prevent doing daily activities; 8 cm: Awful, hard to do anything; 9 cm: Can not bear the pain, unable to do anything; 10 cm: As bad as it could be, nothing else matters) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long-term satisfaction of patients with OLP treated with honey, recurrence rates, and quality of life after one year of treatment | baseline to 1 year | Patient Satisfaction: Measured using a Likert scale questionnaire (e.g., 1-5, where 1 = very dissatisfied and 5 = very satisfied). Recurrence % or Complications Quality of Life: Reassess by using OHIP-14 at each follow-up. |
Countries
Saudi Arabia
Contacts
PRINCIPAL_INVESTIGATORSally A ElHaddad, Assist. Prof
Dar AlUloom University, SA
Outcome results
None listed