Topical "Non-Aromatic Very Rich in Steranes" (NAVS) Naphthalan for the Treatment of Oral Mucosal Diseases
Oral Lichen Planus, Recurrent Aphthous Stomatitis
About this trial
This is an interventional treatment trial for Oral Lichen Planus focused on measuring NAVS Naphthalan, Betamethasone dipropionate, Topical treatment
Eligibility Criteria
Inclusion Criteria:
- for OLP patients: adult patients with a clinically and histologically proven OLP (Al-Hashimi et al, 2007)
- for RAS patients: in the acute stage of the disease, according to Lehner (1968), at least 2 episodes per year
Exclusion Criteria:
- for OLP patients: younger than 18 years, hepatobiliary system diseases, lichenoid reaction (amalgam, drugs) or lichen planus with lesions in contact to restorative materials (Zakrzewska et al, 2005), the current comparative systemic or local anti-inflammatory treatment (antibiotics, corticosteroids, non-steroidal antirheumatic drugs, chemotherapeutics) (Lo Muzio et al, 2001; Nolan et al, 2006; Rodriguez et al, 2007) and pregnancy.
- for RAS patients: patients younger than 18 years, haematological deficits (assessed by complete blood count (CBC), iron (Fe), vitamin B12, hypersensitivity to toothpaste and oral mouth rinse solutions (assessed by medical history) (Nolan et al, 2006), pregnancy, inflammatory bowel disease (assessed by medical history), significant immunodeficiencies, current comparative systemic or topical anti-inflammatory treatment (antibiotics, corticosteroids, nonsteroidal antirheumatics, chemotherapeutics) (Lo Muzio et al, 2001; Nolan et al, 2006; Rodriguez et al, 2007).
Sites / Locations
- School of Dental medicine, University of Zagreb
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
NAVS Naphthalan
0.05% Betamethasone dipropionate
NAVS oil in adhesive powder in a volume ratio 2:1, to apply on the affected mucosa three times daily during 4 weeks for OLP patients; NAVS oil in adhesive powder in a volume ratio 2:1, to apply on the affected mucosa three times daily during 5 days for RAS patients
0.05% Betamethasone dipropionate in adhesive powder in a volume ratio 1:1, to apply on the affected mucosa three times daily during 4 weeks for OLP patients; 0.05% Betamethasone dipropionate in adhesive powder in a volume ratio 1:1, to apply on the affected mucosa three times daily during 5 days for RAS patients