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.: PACTR202010595765285 Date of Approval: 26/10/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Cytotoxic Assessment Of 3D Printed Photoinitiated Prosthodontic Resins
Official scientific title Cytotoxic Assessment Of 3D Printed Photoinitiated Prosthodontic Resins
Brief summary describing the background and objectives of the trial The development of different types of materials with various applications in dentistry practice is an area of intense growth and research due to its importance in oral health. The 3D printed resins are among the diverse materials currently used in restoration or in prosthetic appliances, but investigations detailing the biocompatibility of 3D printed resins used with long-term dental applications remain scarce. The aim of the study is to evaluate the in vitro cellular behavior of human gingival fibroblasts "HGFs" when put in contact with two different 3D printed resins and heat polymerized acrylic resin.
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 Prevention
Anticipated trial start date 01/11/2020
Actual trial start date
Anticipated date of last follow up 30/06/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 72
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
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 3D printed photoinitiated prosthodontic resins for 24, 48, and 72 hours Assess their cytotoxic effect on normal oral tissue for different times compared to Heat-polymerized acrylic resin 48
Control Group Heat polymerized acrylic resin for 24, 48, and 72 hours Compare their cytotoxic effect to the experimental resins (3D printed resins) on normal oral tissue for different times 24 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with healthy attached keratinized gingival tissues Any systemic disease Patients with allergy Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 40 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 01/09/2020 Research Ethics Committee at Faculty of Dentistry Alexandria University IORG0008839
Ethics Committee Address
Street address City Postal code Country
Champollion Street El Messalah Alexandria 21521 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Biocompatibility of two 3D printed photoinitiated prosthodontic resins at 24, 48 and 72 hours
Secondary Outcome Visual analog scale (VAS) on patients at 24, 48 and 72 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient clinics of at Faculty of Dentistry Alexandria University Champollion st, El Azareta Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Maisa Mohamed Farid Shaaban Gomaa Champollion street, Azarita Alexandria 21521 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Prosthodontics Department Faculty of Dentistry Alexandria University Champlion street elmessalah Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Faten salah Champollion street Azarita Alexandria 21521 Egypt
Radwa Ali Mehanna Champollion street Azarita Alexandria 21521 Egypt
Mervat Elsayed Champollion street Azarita Alexandria 21521 Egypt
Maisa Mohamed Farid Shaaban Gomaa Champollion street Azarita Alexandria 21521 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Faten Salah faten_salah@hotmail.com 00201155252515 Champollion street Azarita
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Prosthodontics Faculty of Dentistry Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Mervat Elsayed mervodoctor2007@hotmail.com 00201283803657 Champollion street Azarita
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Lecturer of Prosthodontics 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 e-mail to elsayedamr@yahoo.com (public relation) 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