Clinical Trial: Topical "Non-Aromatic Very Rich in Steranes" (NAVS) Naphthalan for the Treatment of Oral Mucosal Diseases

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Nonaromatic Naphthalan - Composition Study and Biological Effects on Epithelial Tissues

Brief Summary: This study evaluates the effectiveness of topical NAVS naphthalan in the treatment of oral lichen planus (OLP) and recurrent aphthous stomatitis (RAS). Half of participants with OLP and RAS will receive topical NAVS naphthalan in adhesive paste, while the other half will receive 0.05%-betamethasone dipropionate in adhesive paste. Our hypothesis is that NAVS could be efficient in the treatment of OLP and RAS, with effects comparable to that of topical steroids.

Detailed Summary:

Non-Aromatic-Very rich in Steranes (NAVS) naphthalan is a transparent, earth mineral oil prepared by a complex set of procedures of separations and refining, starting with a special oil that is used as the raw material for brown naphthalane, which has been successfully used in the treatment of psoriasis. In order to remove potentially mutagenic polycyclic aromatic hydrocarbons (PAHs), liquid chromatography was used. UV / VIS (ultra violet / visible light) spectrophotometry confirmed that PAHs were bellow detection threshold. Additionally, the precise distillation process has concentrated steranes, which are important bioactive constituents. Since steranes contain similar chemical structure as well-known bioactive substances, such as vitamin D3 and steroid hormones, the assumption is that NAVS is effective in the treatment of oral diseases which have immune genesis such as OLP and RAS.

Today, topical steroid preparations are considered as first-line therapy for many chronic immune-mediated inflammatory diseases of the oral mucosa. Risks of short-term use of topical corticosteroids are clinically insignificant, while their long-term use is not recommended because of potential side effects, such as mucosal atrophy, secondary infection with Candida albicans, possible systemic absorption and suppression of the adrenal gland.

Study participants are adult patients of the Department of Oral Medicine, School of Dental Medicine in Zagreb, with a clinically and histologically proven OLP or RAS in the acute stage of the disease.The treatment outcome of the OLP patients will be measured by clinical improvement and subjective symptomatic relief. The outcome of RAS patients treated by NAVS naphthalan or by betamethasone will be measured clinically by the decrease in number and size of lesions as well as by subjective symptomatic relief o
Sponsor: Ivan Alajbeg

Current Primary Outcome:

  • The change of presence of reticulation, erythema and ulceration on mucosal surfaces [ Time Frame: 28 days per patient ]

    Clinical improvement of OLP lesions after treatment will be scored (Pibooniyom et al.,2005). This clinical scale measures the presence of reticular, erythematous and ulcerative lesions on oral mucosal surfaces, providing a score by adding those values.

    Investigator will assess patients' lesions on oral mucosal surfaces, on day 0 and day 28 and provide score for each assessment. The change of this score between the two time points is a measure of clinical efficacy of applied treatment modality.

    Calibration process : three examiners independently reviewed and evaluated photo of the individual patient. The second evaluation of photographs was a week after to assess the objectivity of the reading on the first visit. Once the examiners reviewed the photographs twice with one-week gap, the obtained results were analysed using Spearman "rank" correlation to determine intra- and inter-observer reliability.

  • The change in the number of RAS lesions [ Time Frame: 5 days per patient ]
    The number of RAS lesions will be recorded on day 0 and on day 5 after the start of treatment (Khandwala et al, 1997). The change in the number of lesions between the two time points is a measure of clinical efficacy of applied treatment modality.
  • The change in the diameter of RAS lesions [ Time Frame: 5 days per patient ]
    The change in the diameter of RAS lesions (in millimeters

    Original Primary Outcome: Same as current

    Current Secondary Outcome: Adverse reactions to treatment modalities in OLP patients [ Time Frame: 28 days per patient ]

    In OLP patients application of both treatment modalities lasts for 28 days. The occurrence of oral Candidal infection or irritation will be recorded by clinician on day 28. The frequency of each will be compared between two treatment groups.


    Original Secondary Outcome: Same as current

    Information By: University of Zagreb

    Dates:
    Date Received: June 8, 2016
    Date Started: December 2010
    Date Completion:
    Last Updated: September 29, 2016
    Last Verified: September 2016