Lichen Planus, Oral
Conditions
Brief summary
The primary objective of this study was to compare the therapeutic efficacy of Tacrolimus gel versus an anti-inflammatory mouthwash in an oral solution for the management of patients suffering from symptomatic OLP. The secondary objective was to analyze which one of the two treatments induced a greater risk of developing side effects.
Detailed description
Thirty nine patients were assigned, through a randomized design, to receive tacrolimus ointment 0.1% or a mouthwash composed of calcium hydroxide 10%, hyaluronic acid 0,3%, umbelliferone and oligomeric proanthocyanidins, or an anti-inflammatory mouthwash (mouthwash which contains calcium hydroxide, hyaluronic acid, Umbelliferone and Oligomeric Proanthocyanidins) for 3-months. At baseline (T0) and after 3 months (T1), patients were subjected to clinical and oral assessments and were evaluated for the symptoms (Numerical Pain Scale, NRS score) and signs (Thongprasom's score) of OLP. Data were calculated using T-test for the dependent variable, Wilcoxon test and Mann-Witney u test.
Interventions
DRUGOral lichen clinical Healing evaluation
Treatments were topically applied for 5 days
Sponsors
University of Catania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* age ≥ 18 years; * clinical diagnosis and histological diagnosis of OLP on the basis of WHO criteria; * presence of symptoms related to OLP.
Exclusion criteria
* presence of systemic conditions that may have affected the study results; * state of pregnancy or breastfeeding; * histological signs of dysplasia; * drugs inducing a lichen response (ACE-inhibitors, β-blockers, etc.); * treatment of OLP in the six months prior to the start of the programme; * presence of extraoral lesions (genital, skin and other) * history of previous immunodeficiency or HIV seropositivity; * previous allogeneic bone marrow transplantation; * presence of systemic lupus erythematosus or other autoimmune diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Mucosal healing | 180 days | Patients clinically were evaluated using the scale used by Thongprasom et al. as reference. This gives a score that varies from 0 to 5, using a millimetre reference: 0, in the absence of lesions; 1, in the presence of hyperkeratosis streaks; 2, in the presence of an atrophic area less than 1 mm2; 3, in the presence of an atrophic area greater than 1 mm2; 4, in the presence of an erosive area less than 1 mm2; 5, in the presence of an erosive area greater than 1 mm2. In the presence of multiple injuries, the value has been calculated by summing the values of each injury. |
Countries
Italy
Outcome results
None listed