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.: PACTR201901914716040 Date of Approval: 23/01/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Effect of Two Zirconia Surface Treatments on the Immediate Placement and Loading of CAD/CAM Root Analogue Zirconia Implants
Official scientific title The Effect of Two Zirconia Surface Treatments on the Immediate Placement and Loading of CAD/CAM Root Analogue Zirconia Implants (In Vivo and In Vitro Study
Brief summary describing the background and objectives of the trial Replacement of the badly destructed teeth by a novel root analogue zirconia implant (RAZI), in attempt to decrease the surgical intervention, and facilitate the process of immediate placement into a fresh extraction sockets.it may be beneficial especially in multirooted teeth that share the maximum load during function. This study will be an attempt to evaluate the clinical success of immediate placement root analogue zirconia implants having two different surface treatments.
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: Devices
Anticipated trial start date 01/01/2016
Actual trial start date 01/10/2016
Anticipated date of last follow up 01/10/2017
Actual Last follow-up date 01/10/2017
Anticipated target sample size (number of participants) 14
Actual target sample size (number of participants) 14
Recruitment status Stopped early/ terminated
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 Zirconia discs 1 year Two surface treatments were used untreated, Air abrasion and air abrasion+ ultraviolet treatment 7
Control Group Root analogue zirconia implant 1 year Two groups with surface treatments as in the laboratory part 7 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Edentulous Patients Systemic diseases affect osseointegration. Smoking. Large periapical radiolucency. Insufficient bone quantity & quality. History of drugs or alcohol abuse. Periodontal pocket ≥ 5 mm Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 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 28/09/2015 IRB Faculty of Denistry Alexandria University
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street El Messalah Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Success of RAZI, as a substitute for titanium implant. Clinical evaluation and radiographic evaluation at 3, 6, and 12 months
Primary Outcome Effectiveness of the surface treatments used in the laboratory part At 3, 6, and 12 months
Secondary Outcome Decrease the risk for surgical interventions. At 3, 6, and 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Conservative Dentistry Faculty of Dentistry Alexandria University Champilon street, Azarita Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Yasser Mohamed Champollion St. , El Azareta - Alexandria - Egypt. Alexandria 21521 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Conservative Dentistry Faculty of Dentistry Alexandria University Champilon street, Azarita Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Yasser Mohamed Champollion St. , El Azareta - Alexandria - Egypt. Alexandria 21521 Egypt
Yousreya Shalaby Champollion St. , El Azareta - Alexandria - Egypt. Alexandria 21521 Egypt
Rania abdelaziz Champollion St. , El Azareta - Alexandria - Egypt. Alexandria 21521 Egypt
Dawlat Mostafa Champollion St. , El Azareta - Alexandria - Egypt. Alexandria 21521 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Yousreya Shalaby Yousreya_Shalaby@gmail.com 00201002333413 Champollion St. , El Azareta - Alexandria - Egypt.
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Removable Prosthodontics Faculty of Dentistry Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Rania Abdelaziz Raniaabdelaziz72@hotmail.com 00201552510658 Champollion St. , El Azareta - Alexandria - Egypt.
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Assistant Professor of Removable 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
No
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