Myrtex Oral Paste

Treatment of Recurrent Aphthous Stomatitis (RAS)

Recurrent Aphthous Stomatitis (RAS) is the most common ulcerative condition of the oral cavity. It is a multi-factor disorder which is related to factors such as trauma, deficiency of hematopoietic factors, mental stress, infectious factors, dietary allergies, genetic factors, HIV infection and systemic disease, like Crohn’s disease, ulcerative colitis, Behjet’s syndrome and celiac disease (gluten-sensitive enteropathy),and affects 5-25% of the general population. The main cause of RAS is not thoroughly known and the most discussed physiopathological mechanisms include inflammatory reactions and hypersensitivity.

Depending on the shape of the lesion, clinical manifestations of aphtha are of 3 types: minor (less than 1 cm), major (more than 1 cm) and herpetiform aphtha (which is not related to herpetic infection). The most prevalent form of RAS is the minor one which comprises 80% of the recurrent aphthous ulcers.

Generally, minor aphtha engages the movable and nonkeratinized mucosa, like the mouth, lips and the external rim of the tongue. 24-48 hours before formation of minor aphtha, the patient reports a prickly sensation or burning of the mucus. At this stage, the mucus membrane may look red or normal. Within one day or more, an oval or round ulcer with a grey-white center and red periphery forms.

Formation of aphtha may result in difficulty in speaking, alimentation and swallowing, and therefore negative impact on the quality of life of the patient. The treatment of RAS is based on alleviation of symptoms and is generally based on experimental evidence.

Common myrtle (Myrtus communis) has antibacterial and analgesic effects; in folk medicine in Iran its leaves have been used as mouthwash for treatment of candidiasis.

To study the clinical efficacy of a mucoadhesive paste containing common myrtle essential oil in symptomatic treatment of RAS, in a randomized, double-blind clinical trial, 25 students placed on their aphthous ulcers for 10 days, 3 times a day, either the mucoadhesive paste containing common myrtle essential oil (group A, 14 patients) or placebo (group B, 11 patients). The patients were examined on days one, two, six and ten, and the larger diameter of the aphthous ulcer was measured by periodontal probe and registered. The pain and burning was registered daily by the patients using Visual Analogue Scale (VAS). Based on the results of this study, the time needed for the burning to stop was 1.64±0.74 days in group A and 4.91±1.30 days in group B. On the sixth day of the study, the mean size of the aphthous lesion was 0.14±0.36 mm in group A, and except one patient, the aphtha had recovered in all patients in group A, while the mean size of the aphthous lesion was 2.73±1.68 mm in group B. On the tenth day of the study, the mean size of the aphthous lesion was zero in group A (100% of aphthous ulcers had healed), while it was 1.18-1.17 mm in group B. 64.3% of the patients in group A were entirely satisfied with their treatment and 35.7% were satisfied, while in group B 81.8% of the patients were dissatisfied and only 18.2% were satisfied with their treatment. The degree of adhesion of the mucoadhesive paste to the oral mucosa was identical in both groups, and according to the report of the patients, the maximum time of adhesion of this paste to the mucosa varied from 10 minutes to one hour.

  • Before using the product, pat dry the affected spot in the oral cavity with soft, sterile gauze.
  • Apply a suitable amount of the product 3 times per day (after breakfast and lunch and before sleep) on the aphthous ulcer and gently pressure.
  • Avoid eating and drinking in the one hour after using the product.

Dosage form

Oral Paste

Packaging

5 g aluminium barrier laminate tube in cardboard box

Patient information leaflet inside

Ingredients

  • Essential oil of common myrtle (Myrtus communis)

Active Ingredients

  • 1,8-cineole

Contraindications and Cautions

Pregnancy and lactation.

Adverse Effects

With the recommended amounts, no adverse reaction has been reported.

 

Drug Interaction

No sufficient evidence regarding the product’s interaction.

 

Administration during Pregnancy and Lactation

Not to be administered during pregnancy and lactation.

 

Further Notes

  • Keep Myrtex Oral Paste, like all other medication, away from sight and reach of children.
  • Recap the tube right after administration.
  • Keep the medicine away from light and in 15-30°C.
  • Keep this leaflet; you may need to read it again.

Based on presence of 8.55 mg 1,8-cineole per g of the product.