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.: PACTR201512001348246 Date of Approval: 15/11/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title immediate implant using nanobone versus autogenous bone for treatment of patients with unrestorable single tooth.
Official scientific title evaluation of surgical time, post-operative pain and marginal bone loss in immediate implant using "nanobone" versus "autogenous bone" for treatment of patients with unrestorable single tooth.
Brief summary describing the background and objectives of the trial A successful implant therapy require appropriate hard and soft tissue, perfect implant position, appropriate alveolar ridge architecture and integration of the implant. after tooth extraction bone resorption takes place and affect the quantity and quality of the bone resulting in inadequate bone volume for implant placement and future prosthetic restoration and impair the esthetic, so insertion of implant immediately following tooth extraction reduce bone loss and enhance esthetics.the fresh socket of extracted tooth is wider than the implant diameter and the distance between the implant and the bone called Peri-implant gap which influence the stability, osseointegration of the implants and esthetics. using bone graft in this gap between bone and implant enhance osseointegration and post-operative healing. autogenous bone graft considered the gold standard graft material for filling defects as it is osteogenic,osseoconductive and osseoinductive, however this approach obtained from the primary donor site for harvesting bone in the oral cavity which requires longer surgical procedure and produce not enough bone volume. there are several post-operative complication may happen as donor site morbidity and swelling,discomfort and pain, so alternative treatment has been suggested using biomaterials to fill the gap and reduce adverse effect of autogenous grafts.Several studies evaluate the success rate of implants with "autogenous" bone graft versus other synthetic guided bone regeneration materials. Nano porous grafting material as a new synthetic material "nanobone" nanocrystalline hydroxyapatite embedded in a porous silica gel matrix has oseoconductive and biomimetic properties integrate with the host bone. the sub-micron modification in bone substitutes enhance osteogenic property. the objective of this study is to measure surgical time, pain, implant stability and marginal bone loss in immediate implant placement with using autogenous bone graft versus nanobone graft.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Unrestorable single tooth, fracture tooth in esthetic zone
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/01/2016
Actual trial start date 01/01/2016
Anticipated date of last follow up 01/01/2018
Actual Last follow-up date 01/01/2018
Anticipated target sample size (number of participants) 18
Actual target sample size (number of participants) 18
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 Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group nanobone graft at surgery nano hydroxy apatite graft harvested from donor site and fil the defect between the implant and bone wall 9
Control Group autogenous bone graft at surgery autogenous bone graft harvested from from donor site and fill the gap between the implant and bone wall 9 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients suffering from unrestorable tooth. Good oral hygiene. Candidate for classical implant placement. Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome. Patients with severely atrophic ridges requiring a staged grafting procedure. Intra oral soft tissue defect that would affect the closure of the intra oral wound. Patients with any systemic disease that may affect normal healing. Patient with bad oral hygiene. 18 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
Yes 08/07/2015 Research ethics committee faculty of oral and dental medicine faculty
Ethics Committee Address
Street address City Postal code Country
11 el-saraya street al manyal, cairo Cairo 11553 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Surgical pain During 3 days after surgery.
Primary Outcome Intra operative time . During surgery.
Secondary Outcome Marginal bone loss Pre-surgery. Reentry stage.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient clinic of the oral medicine and periodontology department 11 el-saraya street almanyal Cairo 11553 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Samar ahmed nouby adam 79 bostan street sheikh zayed. Cairo 12588 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of oral and dental medicine. 11 el-saraya street almanyal Cairo 11553 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Not applicable
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator samar nouby samarnouby.perio@gmail.com +201001752693 79 bostan street sheikh zayed
City Postal code Country Position/Affiliation
cairo 12588 Egypt assistant lecturer in faculty of oral and dental medicine.
Role Name Email Phone Street address
Scientific Enquiries Azza Elarab azza_ezzelarab@yahoo.com +201002500455 elsaraya street elmanyal
City Postal code Country Position/Affiliation
cairo 11553 Egypt
Role Name Email Phone Street address
Scientific Enquiries Azza Elarab azza_ezzelarab@yahoo.com +201002500455 11 elsaraya street elmanyal
City Postal code Country Position/Affiliation
cairo 11553 Egypt professor in oral and dental medicine faculty
REPORTING
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