Treatment Outcomes and Patient Satisfaction of Oral Lichen Planus Treatment
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age35-60
SponsorDar Al Uloom University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Honey in orabase 1: 1 paste
DrugThe 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
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: Group I with OLP at buccal mucosaExperimental treatment 1 intervention
Group B: Group II with OLP at buccal mucosaActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Clinical Assessment of OLP lesions using OLP score
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.
Time frame
baseline to 1 year2
Pain assessment using Visual analogue scale (VAS)
(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)
Time frame
baseline- to 1 yearSecondary outcomes
1
Long-term satisfaction of patients with OLP treated with honey, recurrence rates, and quality of life after one year of treatment
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.
Time frame
baseline to 1 yearSponsors and contacts
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Source ClinicalTrials.gov