Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202210598505787 Date of Approval: 04/10/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Development and Evaluation of Buccal Mucoadhesive Polymer Formulations Containing Antifungal Drugs of the Management of Denture-Stomatitis
Official scientific title Development and Evaluation of Buccal Mucoadhesive Polymer Formulations Containing Antifungal Drugs of the Management of Denture-Stomatitis.
Brief summary describing the background and objectives of the trial Denture stomatitis commonly affects denture users mainly due to oral candidiasis (OC). Chronic erythematous candidiasis (CEC) commonly referred to as Candida-associated denture stomatitis, presents as a reddening of the mucosa beneath the fitting surface of a denture. CEC is the most prevalent form of oral candidiasis, with up to 75% of denture wearers having clinical signs, although the individual is often unaware of infection. Oral candidiasis (OC) can be treated using traditional formulations such as mouthwashes, lozenges, and oral gels. These formulations are often unable to maintain effective antifungal levels for an extended time; they suffer several drawbacks such as need for repeated applications, possibility of inaccurate dosing, easily washable by saliva, low adherence to denture and tissue surface and fast release of the active agent. Mucoadhesive drug delivery systems that attach to the buccal mucosa and stay in place for an extended period of time could offer better alternatives for treating CEC. Antifungal mucoadhesive films, in particular, offer fixed antifungal dose in each film, and cushioning effect under hard denture fitting surface which contributes to pain relief. The present study aimed to formulate and assess the effect of a denture-adhesive and palate-mucoadhesive buccal film in the management of upper denture stomatitis, caused by Candida albicans, in comparison to a marketed oral gel (Daktarin® Janssen Pharmaceutica N.V, Belgium). The developed antifungal mucoadhesive films present an attractive alternative avoiding gel drawbacks.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 20/01/2020
Actual trial start date 20/01/2020
Anticipated date of last follow up 01/05/2022
Actual Last follow-up date 01/05/2022
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants) 48
Recruitment status Completed
Publication URL N/A
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group HPMC film F1 50 mg in each Film application Twice/day At morning and noon (every 6-8 h during the day) Film was applied to the fitting surface of the denture 12
Experimental Group HPMC and SCMC film F2 50 mg in each Film application Twice/day At morning and noon (every 6-8 h during the day) Film was applied to the fitting surface of the denture 12
Experimental Group MN Nanoparticles loaded in mucoadhesive film F3 50 mg in each Film application once/day At morning Film was applied to the fitting surface of the denture 12
Control Group Miconazol oral gel half a spoonful of gel containing 62 mg miconazole Four times /day (every 3 – 4 h during the day) The oral gel was applied With a clean finger, a small amount of gel (equal to half a spoonful of gel was applied to the denture palatal fitting surface before placing the denture in the mouth 12 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Providing consent prior to participation in the study Wearing a maxillary complete acrylic denture Clinically diagnosed with grade II denture stomatitis Cytologically diagnosed with denture stomatitis Patients with systemic disease and conditions which predispose to Candida spp. (e.g.: diabetes, cardiovascular disease and viral hepatitis). Smoking patients. Having a history of chemotherapy/radiotherapy or under warfarin therapy Patients with previous history of antifungal treatment. Patients with history of corticosteroids (systemic or local buccal) within last 3 months. Contact allergy. Patient with history of antibiotics (systemic or local buccal) within one month from study. Having oral mucosal lesions other than from denture stomatitis Being scheduled to replace existing dentures with new ones during the period of the study Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/01/2020 The Ethics Committee of the Faculty of Medicine Alexandria University IRB No 00012098
Ethics Committee Address
Street address City Postal code Country
Champollion St., El Messalah, Azarita Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Colony counting (Candida albicans Colony count) Before treatment application And after 10 days
Secondary Outcome Visual Analogue Scale for Pain (VAS) Before treatment application After 3 days After 10 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient clinic of the Department of Oral Medicine Periodontology Oral diagnosis and Radiology Faculty of Dentistry Alexandria University Champolion St., Azarita Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Basant A AbouTaleb Kanal Elmahmoudia street Alexandria 21311 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Oral Medicine Periodontology Oral diagnosis and Radiology Faculty of Dentistry Alexandria University Champolion St., Azarita Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Basant A Abou Taleb Kanal Elmahmoudia street Alexandria 21311 Egypt
Ingy F Elzoheiry Champolion St., Azarita Alexandria 21521 Egypt
Gehan S Kotry Champolion St., Azarita Alexandria 21521 Egypt
Nawal M Khalafallah 1 elKhartoum square Azarita Alexandria 21521 Egypt
Sherif H Kandil 163 Horyya road Elshatby Alexandria 21526 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Gehan Kotry jkotry2@gmail.com 00201006040146 Champollion Street Azarita
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Oral Medicine Periodontology Oral Diagnosis and Radiology Faculty of Dentistry Alexandria University Egypt
Role Name Email Phone Street address
Scientific Enquiries Basant Abou Taleb Bassant.abotaleb@pua.edu.eg 00201005642097 Kanal Elmahmoudia street
City Postal code Country Position/Affiliation
Alexandria 21311 Egypt Lecturer of Pharmaceutics Faculty of Pharmacy Alexndria Egypt
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send an e-mail to elsayedamr@yahoo.com (public relations) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information