Niosomal Propolis as Oromucoadhesive Film: In-vitro, Ex-vivo & In-vivo Investigations

Drug Effect Clinical Trial

Official title:

Propolis-based Nanovesicles as Oromuco-adhesive Film: Novel Therapeutic Drug Delivery System for Treatment of Oral Recurrent Aphthous Ulcer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03615820
• Other study ID #: PPEADHNIO-2018-4
• Status: Completed
• Phase: Phase 1
• Start date: January 1, 2018
• Est. completion date: January 30, 2018

Study information

• Verified date: July 2018
• Source: British University In Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 30, 2018
• Est. primary completion date: January 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 45 Years

Eligibility

Inclusion Criteria:

• Patients suffer from aphthous ulcer

Exclusion Criteria:

• Chronic diseases ,

• Hospitalized

Related Conditions & MeSH terms

• Drug Effect
• Drug Effect Prolonged

Intervention

Drug:
• Niosomal PPE oromucoadhesive film
Niosomal PPE oromucoadhesive film in which Propolis entrapped in niosomal vesicles and incorporated in oromucoadhesive film
• Oromucoadhesive film
Oromucoadhesive film without PPE control testing which represents Placebo group

Locations

Country	Name	City	State
Egypt	Mona G Arafa	Cairo
Egypt	Mona G Arafa	New Cairo	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
British University In Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of the onset of ulcer size reduction	Niosomal PPE in oromuco-adhesive film was prepared & given to 12 patients to examine the onset of ulcer size reduction The patients were first instructed how to apply the mucoadhesive film of 2 cm2 on the oral ulcer and then they were handed a checklist for monitoring the actual improvement that was indicated by the reduction of the size of ulcer.	Fifteen Days
Secondary	Duration of complete ulcer healing	oromuco-adhesive film was prepared & given to 12 patients to examine the duration of complete healing.The patients were first instructed how to apply the mucoadhesive film of 2 cm2 on the oral ulcer and then they were handed a checklist for monitoring the actual improvement that was indicated by the complete healing of ulcer.	Fifteen Days