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: www.pactr.org Trial no.: PACTR201303000518124 Date registered: 2013/03/13 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 Purpose of the trial Treatment Anticipated trial start date 2013-06-01 Actual trial start date 2013-07-12 Anticipated date of last follow up 2014-03-11 Actual date of last follow up 2015-05-06 Anticipated target sample size (number of participants) 6    Actual target sample size (number of participants) 6    Recruitment status Open to recruitment: actively recruiting participants Secondary Ids Issuing authority/Trial register Links to Secondary ID 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 Min age Max 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 Years 80 Years 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 2013/03/11 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 Fax Principal Investigator Dr khaled selim khaledselim77@gmail.com 01006218050 27031599 Street address City Postal code Country Position / Affiliation 45 A , nirco , maadi district cairo 002 Egypt assistant lecturer at periodontics department Role Name Email Phone Fax Public Enquiries Dr amr el khadem amrelkhadem@gmail.com 01001162401 23787774 Street address City Postal code Country Position / Affiliation 9 zahraa road maadi district cairo 002 Egypt lecturer at prosthodontic department Role Name Email Phone Fax Scientific Enquiries Dr ahmed el khadem khaledselim77@gmail.com 01227520298 23787774 Street address City Postal code Country Position / Affiliation 9 zahraa road maadi district cairo 002 Egypt head of evidence based comittte- cairo univ