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.: PACTR201603000652225 Date of Registration: 21/09/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Implant retained overdenture
Official scientific title The Effect of Using Thermo-plastic Acrylic Denture Base versus Conventional Acrylic Denture Base on The Supporting Structures in Implant Retained Mandibular Over-denture: A Randomized Clinical Trial
Brief summary describing the background and objectives of the trial This study is conducted to Compare the effect of using the thermo-plastic acrylic denture base versus using the conventional acrylic denture base on the supporting structures in implant retained mandibular overdenture.
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 01/01/2014
Actual trial start date 01/01/2014
Anticipated date of last follow up 30/09/2014
Actual Last follow-up date
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 12
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 Each participant will be randomly assigned following simple randomization procedure by using closed white envelops (12 closed white envelopes) which assign the group to be followed. Those closed envelops includes 6 paper charts (fig. 1) and 6 paper charts (fig. 2), which are folded three times not to show its contents to assure random assignment. Simple randomisation using by using procedures such as coin-tossing or dice-rolling Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Each participant will be randomly assigned following simple randomization procedure by using closed white envelops (12 closed white envelopes) which assign the group to be followed. Those closed envelops includes 6 paper charts (fig. 1) and 6 paper charts (fig. 2), which are folded three times not to show its contents to assure random assignment. Simple randomisation using by using procedures such as coin-tossing or dice-rolling Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Thermoplastic acrylic denture base material" Versacryl" thermoplastic denture base material 6
Control Group Conventional acrylic denture base 6 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Patients are free from any medical, physical or mental handicapping condition. ¿ Ages range from 45-60 years. ¿ Completely edentulous and accept to wear implant overdenture. Any known sensitivity or adverse reactions to the methaymethacrylate . 45 Year(s) 60 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
No 01/08/2013 Post graduate ethics committee
Ethics Committee Address
Street address City Postal code Country
cairo university,Manyal -Giza cairo 002 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1ry outcome: Patient satisfaction Questionnaire Scores M3 M6 M9
Secondary Outcome Bone height around miniimplat, device M3 M6 M9
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo Univesity Manyal - Giza Cairo 002 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funding 27 Ismael Helmy st, Smouha Alexandria 002 03 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University Manyal - Giza Cairo 002 Egypt University
Primary Sponsor Evidence Based Committee Cairo University, dental school, Manyal -Giza Cairo 002 Egypt University
Primary Sponsor Prosthesis department Cairo uinversity, dental school, Manyal-Giza Cairo 002 Egypt University
Secondary Sponsor Research committee Cairo university, dental school, Manyal -Giza Cairo 002 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Alaa Aboul Ela Cairo 002 Egypt
Mahmoud Salloum 17 Ahmed Sedeek st, Sidi Gaber Alexandria 002 03 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Miran Sultan miran_sultan@hotmail.com 002 012 27550596 27 Ismael Helmy st, Smouha
City Postal code Country Position/Affiliation
Alexandria 002 03 Egypt Researcher
Role Name Email Phone Street address
Public Enquiries Mahmoud Salloum mahmoud.salloum@pua.edu.eg 002 010 01633507 17 Ahmed Sedeek st, Sidigaber
City Postal code Country Position/Affiliation
Alexandria 002 03 Egypt Lecturer at prosthodontic department
Role Name Email Phone Street address
Scientific Enquiries Alaa Aboul ela dr_alaa_aboulela@hotmail.com 002 01222151949 Faculty of dentistry, Cairo university. Manyal ,Giza
City Postal code Country Position/Affiliation
Cairo 002 Egypt professor at prosthodontic department
REPORTING
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