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

NCT ID: NCT03615820

Last Updated: 2018-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2018-01-30

Brief 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.

Conditions

Drug Effect; Drug Effect Prolonged

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Niosomal PPE oromucoadhesive film

Niosomal PPE oromucoadhesive film in which PPE entrapped in niosomes then incorporated in oromucoadhesive films

Group Type: EXPERIMENTAL

Niosomal PPE oromucoadhesive film

Intervention Type: DRUG

Niosomal PPE oromucoadhesive film in which Propolis entrapped in niosomal vesicles and incorporated in oromucoadhesive film

Oromucoadhesive film

Intervention Type: DRUG

Oromucoadhesive film without PPE control testing which represents Placebo group

Oromucoadhesive film

Oromucoadhesive film that has no niosomal PPE in its content

Group Type: PLACEBO_COMPARATOR

Niosomal PPE oromucoadhesive film

Intervention Type: DRUG

Niosomal PPE oromucoadhesive film in which Propolis entrapped in niosomal vesicles and incorporated in oromucoadhesive film

Oromucoadhesive film

Intervention Type: DRUG

Oromucoadhesive film without PPE control testing which represents Placebo group

Interventions

Niosomal PPE oromucoadhesive film

Niosomal PPE oromucoadhesive film in which Propolis entrapped in niosomal vesicles and incorporated in oromucoadhesive film

Intervention Type: DRUG

Oromucoadhesive film

Oromucoadhesive film without PPE control testing which represents Placebo group

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients suffer from aphthous ulcer

Exclusion Criteria

• Chronic diseases ,
• Hospitalized

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

British University In Egypt

OTHER

Sponsor Role: lead

Responsible Party

Mona Gamal Mohamed Afifi Arafa

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mona G Arafa, PhD

Role: PRINCIPAL_INVESTIGATOR

The British University in Egypt

Locations

Mona G Arafa

New Cairo, Cairo Governorate, Egypt

Mona G Arafa

Cairo, , Egypt

Countries

Egypt

Other Identifiers

PPEADHNIO-2018-4

Identifier Type: -

Identifier Source: org_study_id