Niosomal Propolis as Oromucoadhesive Film: In-vitro, Ex-vivo & In-vivo Investigations
Condition: Drug Effect; Drug Effect Prolonged
Study type: Interventional
Phase: Phase 1

Summary: 
      A total of 24 patients suffering from RAU, they were divided into two groups each included 12
      patients. The first group was treated by the propolis mucoadhesive film and the second group
      received the film without the active component (placebo group).Patients were handed a
      checklist for monitoring the actual improvement of the clinical parameters which included;
      duration of disappearance of pain after film application (hours), duration of complete
      healing of the aphthous ulcer (weeks), onset of ulcer size reduction after film application
      (days), duration of propolis film adherence onto the oral mucosa (hours) and finally the
      level of patient satisfaction scaled from 1-10.
    

Detailed description: 
      The present study have been performed on a total of 24 patients suffering from RAU, they were
      divided into two groups each included 12 patients. The first group was treated by the
      propolis mucoadhesive film and the second group received the film without the active
      component (placebo group). Patients were recruited from the out-patient clinic of the Faculty
      of Dentistry, British University in Egypt during a period of 6 months.

      Patients were subjected to thorough clinical examination and history obtaining in order to
      diagnose the oral ulcer by an oral medicine specialist, they were thoroughly informed about
      the study and only those with the oral ulcer within the first day to the third day of
      appearance were included in the present study.

      The exclusion criteria in the present study were the presence of systemic or local disease
      such as hepatitis, cardiac conditions, hypertension, diabetes mellitus, renal problems,
      mental disorders, AIDS and also the use of any immunosuppressive drugs or systemic
      corticosteroids during last three months or using steroid treatment locally in last month,
      also any nutritional supplements, folic acid or antioxidants, pregnancy and nursing.

      All patients were asked to avoid using antiseptics, antibiotics or analgesics, during the
      study as they might aid in curing the oral ulcers. Patients were blinded of receiving either
      propolis or placebo. They were warned about the potentiality of allergic responses that could
      happen to some people and that in case of occurrence of such side effect immediate
      termination of using the film should be implemented.

      The patients were first instructed how to apply the mucoadhesive film of 2 cm2 on the oral
      ulcer and pasted by applying a light force with the finger tip for 20 s, and then were asked
      to apply it two times per day and to refrain from eating for at least one hour after the film
      application on the oral ulcer.

      Patients were handed a checklist for monitoring the actual improvement of the clinical
      parameters which included; duration of disappearance of pain after film application (hours),
      duration of complete healing of the aphthous ulcer (weeks), onset of ulcer size reduction
      after film application (days), duration of propolis film adherence onto the oral mucosa
      (hours) and finally the level of patient satisfaction scaled from 1-10. After total healing
      of the oral RAU, checklists were recollected from patients, the results were tabulated and
      statistical analysis were conducted.
    

Intervention name(s): Niosomal PPE oromucoadhesive film; Oromucoadhesive film
Intervention type(s): Drug; Drug
Intervention description(s): Niosomal PPE oromucoadhesive film in which Propolis entrapped in niosomal vesicles and incorporated in oromucoadhesive film; Oromucoadhesive film without PPE control testing which represents Placebo group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Volunteers will be divided into two groups; each group contained 12 volunteers who will receive one formula of the selected formulae
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nanovesicles; Aphthous ulcer