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.: PACTR201303000518124 Date of Approval: 13/03/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparing peri-implant biological complications in the edenteluous patients receiving screw retained fixed restorations and removable overdentures
Official scientific title Comparing peri-implant biological complications in the edenteluous patients receiving screw retained fixed restorations and removable overdentures
Brief summary describing the background and objectives of the trial the research is targeting edentelous patients , 2 groups are to be designed , one group will recieve a screw retained resoration , the other one will recieve a telescopic overdenture .. a comparision of periimplantitis condition ( mainly crestal bone loss ) & oral hygiene status is going to be done during a period of 18 months
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied dental implants,Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/06/2013
Actual trial start date 12/07/2013
Anticipated date of last follow up 11/03/2014
Actual Last follow-up date 06/05/2015
Anticipated target sample size (number of participants) 6
Actual target sample size (number of participants) 6
Recruitment status 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 computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group overdenture fabrication every 1 month 18 monhs crestal bone loss 3 Dose Comparison
Experimental Group screw retained fixed bridge every 1 m 18 m crestal bone loss 3
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Completely edentulous patients Adequate zone of keratinized mucosa Adequate inter-arch space ( 15mm ) -Any previous surgical intervention ( sinus lifting , ridge augmentation )- -In need of any soft / hard tissue augmentation / grafting - Heavy smokers 30 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 11/03/2013 post graduate ethics committe
Ethics Committee Address
Street address City Postal code Country
cairo university - dental school cairo 002 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome crestal bone loss every 3 months
Secondary Outcome plaque&gingival index Plaque and Bleeding indices ( Mombelli et al , 1987 ) score 0 NO plaque / bleeding score1 Plaque and bleeding detected by running a probe across the smooth marginal surface of the implant score 2 plaque/bleeding seen by viusal inscpection score 3 lots of plaque / spontaneous bleeding
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
cairo university dental school manyal - giza Cairo 002 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
cairo university dental school-prosthesis department manyal - giza cairo 00202 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor evidence based committee cairo university - dental school cairo 002 Egypt University
Primary Sponsor cairo university - dental school manyal - giza cairo 002 Egypt University
Primary Sponsor periodontology and prosthesis department manyal - giza cairo 002 Egypt University
Secondary Sponsor research committe manyal - giza cairo 002 Egypt University
COLLABORATORS
Name Street address City Postal code Country
mahmoud el refai 12 syria street - mohandeseen district cairo 002 Egypt
ahmed reda 54 lebanon street - mohandeseen district cairo 002 Egypt
amr el khadem 9 zahraa road maadi district cairo 002 Egypt
khaled selim 45 A , nirco , maadi distirict cairo 002 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator khaled selim khaledselim77@gmail.com 01006218050 45 A , nirco , maadi district
City Postal code Country Position/Affiliation
cairo 002 Egypt assistant lecturer at periodontics department
Role Name Email Phone Street address
Public Enquiries amr el khadem amrelkhadem@gmail.com 01001162401 9 zahraa road maadi district
City Postal code Country Position/Affiliation
cairo 002 Egypt lecturer at prosthodontic department
Role Name Email Phone Street address
Scientific Enquiries ahmed el khadem khaledselim77@gmail.com 01227520298 9 zahraa road maadi district
City Postal code Country Position/Affiliation
cairo 002 Egypt head of evidence based comittte- cairo univ
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information