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.: PACTR201807117142624 Date of Approval: 26/07/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Prevalence of Oral and Respiratory Microorganisms on the CAD-CAM versus Press Form of Poly-ether-ether Ketone Material for Oral and Maxillofacial Prosthesis
Official scientific title Prevalence of Oral and Respiratory Microorganisms on the CAD-CAM versus Press Form of Poly-ether-ether Ketone Material for Oral and Maxillofacial Prosthesis
Brief summary describing the background and objectives of the trial Extensive maxillofacial defects resulting from trauma or oncologic resection present reconstructive challenges. Various prosthetic materials have been used in the reconstruction of these types of maxillofacial defects. Silicone or heat polymerized poly methyl meth acrylate (PMMA) used for the prosthetic rehabilitation of maxillofacial defects bear the risk of enhanced settlement of microorganisms and biofilm formation. Poly etherether ketone (PEEK) (BioHPP) is a semi-crystalline polyaromatic linear polymer exhibiting excellent combination of biocompatibility, strength, stiffness, and environmental resistance. Recent investigations of PEEK as a biomaterial resulted in the successful rehabilitation of maxillofacial defects. The purpose of the study is to compare the prevalence of the upper respiratory tract and oral microbial flora on the two commercially available forms of PEEK (the conventional press form and the CAD-CAM form) in comparion to the gold standard polymethylmethacrylate (PMMA).
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: Other
Anticipated trial start date 01/06/2017
Actual trial start date 01/06/2017
Anticipated date of last follow up 31/03/2018
Actual Last follow-up date 30/06/2018
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants) 48
Recruitment status Completed
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 Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group CAD CAM PEEK 72 hours of incubation. Milled specimens incubated for biofilm establishment 12
Experimental Group Press form PEEK 72 hours of incubation. Pressed specimens incubated for biofilm establishment 12
Control Group Polished surface PMMA 72 hours of incubation Polished PMMA specimens incubated for biofilm establishment 12 Active-Treatment of Control Group
Control Group Fitting surface PMM 72 hours of incubation PMMA specimens without polishing incubated for biofilm establishment 12 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Normal laboratory tests of (Urea, Creatinine, liver enzymes, CBC, Urine analysis). Smoking Under antibiotic treatment Under any medications Adult: 19 Year-44 Year 25 Year(s) 35 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 24/01/2017 IRB Faculty of Dentistry Alexandria University
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
Secondary Outcome Biofilm formation After 72 hours of incubation
Primary Outcome Surface roughness At the end of experiment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Maxillofacial Department Faculty of Dentistry Alexandria University Champolion St., Azarita Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Dentistry Alexandria University Champolion St., Azarita Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Faten Salah Eldin Champolion St., Azarita Alexandria 21521 Egypt
Showikar Mahmoud Abdel Salam Champolion St., Azarita Alexandria 21521 Egypt
Nourhan Samy Abdelazeem Emam Champolion St., Azarita Alexandria 21521 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Faten Salah eldeen . Faten_salah@Hotmail.com 00201155252515 Champollion St., Azarita
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor at removable prosthodontics
Role Name Email Phone Street address
Scientific Enquiries Showikar AbdelSalam shouikarabdelsalam@gmail.com 00201099671431 Champollion St., Azarita
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor at microbiology and immunology department Faculty of Medicine
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
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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