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.: PACTR202209738652499 Date of Approval: 16/09/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Intralesional Injection of Ethanolamine Oleate Alone or Mixed with Bupivacaine in Oral Venous Malformation (Randomized Controlled Trial)
Official scientific title Intralesional Injection of Ethanolamine Oleate Alone or Mixed with Bupivacaine in Oral Venous Malformation (Randomized Controlled Trial)
Brief summary describing the background and objectives of the trial Vascular anomalies (VAs) arise from blood vessel abnormalities or during endothelial proliferation and are classically distinguished according to the classifications of Mulliken and Glowacki, based on their clinical, histological, and histochemical findings, in hemangiomas and vascular malformations. VMs can be divided into low-flow (venous, capillary, or lymphatic component) and high-flow (arterial or arteriovenous component) The majority of VMs in the oral cavity are venous and slow flow in nature. The main affected areas are the lips, tongue, buccal mucosa, and palate. VMs in the oral cavity may lead to esthetic disorders, pain, and bleeding. Different treatment modalities were proposed, including surgery, laser, embolization, cryotherapy, sclerotherapy, and corticosteroids. Sclerotherapy is an efficient and conservative method for the treatment of VMs. It is a simple procedure that consists of intralesional injection with a low recurrence rate, good esthetic results, and reasonable morbidity. Ethanolamine oleate is a sclerosing agent that causes an acute, dose-related inflammatory reaction of the intimal endothelium of the vein leading to scarring at the inner wall of the veins and possible occlusion of the veins. Adverse reactions related to ethanolamine oleate (EO) include pain during and after injection. Since Ethanolamine Oleate causes post-operative pain, the purpose of this study is to introduce a novel approach of intralesional injection with both Ethanolamine Oleate with Bupivacaine to reduce post-operative pain and com pare both clinically and radiographically the effect on oral venous malformation.
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 01/11/2021
Actual trial start date 01/11/2021
Anticipated date of last follow up 30/11/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 16
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 Ethanolamine Oleate and Lidocaine injection 0.5 ml/ cm 2 weeks between each injection session patients will be treated using intralesional injection with EO and lidocaine 8
Control Group Ethanolamine Oleate only injection 0.5 ml/ cm 2 weeks between each injection session patients will be treated using intalesional injection of EO only 8 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients suffering from oral vascular malformations with a size of 2- 4 cm High flow vascular malformations. Patient’s medication interfering with coagulation and wound healing(e.g., steroids, bisphosphonates, anticoagulants) or specific states preventing the use of EAO (e.g., pregnancy, lactation). Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s) 10 Year(s) 80 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 17/10/2021 Institutional Review Boards IRB at the faculty of dentistry Alexandria University IRB NO 00010556 IORG 0008839
Ethics Committee Address
Street address City Postal code Country
Champollion St., Azarita Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain score visual analogue scale First second and fifth day after injection with 2 weeks intervals between each injection session
Secondary Outcome Size of oral venous malformation After two weeks from the last session of injection
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient Clinic of Alexandria University Teaching Hospital and operated in the Oral and Maxillofacial Surgery Department Faculty of Dentistry Alexandria University Champolion St., Azarita Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Omneya Mashaly 551 Horia Road, Gleem Alexandria 21532 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Oral and Maxillofacial Surgery Department Faculty of Dentistry Alexandria University Champolion St., Azarita Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed El Mahallawy 17 Champolion St., Azarita Alexandria 21521 Egypt
Tasneem Amer 17 Champolion St., Azarita Alexandria 21521 Egypt
Omneya Mashaly 551 Horia Road, Gleem Alexandria 21532 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed ElMahllawy Ahmedelmahllawy@gamil.com 00201227392965 17 Champollion street Al Mesallah Sharq, Al Attarin
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Associate Professor of Oral And Maxillofacial Surgery Faculty of Dentistry Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Tasneem Amer moneestar94@Hotmail.com 00201002992193 17 Champollion street Al Mesallah Sharq, Al Attarin
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Lecturer at Oral And Maxillofacial Surgery Faculty of Dentistry Alexandria University
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