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.: PACTR201307000584171 Date of Approval: 08/07/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Vertical Ridge Augmentation in Anterior Esthetic Zone using Customized Titanium Mesh Versus Inlay Bone Grafting : A Randomized Clinical Trial.
Official scientific title Vertical Ridge Augmentation in Anterior Esthetic Zone using Customized Titanium Mesh Versus Inlay Bone Grafting : A Randomized Clinical Trial.
Brief summary describing the background and objectives of the trial Techniques to improve bone regeneration of segmental defects in the atrophic or dysmorphic (post-oncological) maxilla and mandible have been widely described since the 1990s. Distraction osteogenesis, splitting osteotomy, lateral ridge augmentation, and guided bone regeneration are the most commonly applied methods. One of the main disadvantages of these techniques is the lack of containment of the particulate graft, primarily due to the collapse of the soft tissue during function. During the
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health,Pre-implant surgical grafting procedures,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 11/07/2013
Actual trial start date 11/07/2013
Anticipated date of last follow up 11/07/2013
Actual Last follow-up date 11/07/2013
Anticipated target sample size (number of participants) 14
Actual target sample size (number of participants) 14
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 coin-tossing or dice rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Vertical Ridge Augmentation in Anterior Esthetic Zone using Inlay Bone Grafting tech. One surgical procedure is needed 6 months(follow up) Vertical Ridge Augmentation in Anterior Esthetic Zone using Inlay Bone Grafting tech. 7 Historical
Experimental Group Vertical Ridge Augmentation in Anterior Esthetic Zone using Customized Titanium Mesh One surgical procedure is needed 6 months(follow up) Vertical Ridge Augmentation in Anterior Esthetic Zone using Inlay Bone Grafting tech. 7
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients suffering from vertical ridge deficiency in anterior maxilla that cannot be a candidate for classical implant placement (requiring grafting procedure) 2. Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome. 3. No intraoral soft tissue defect that would render primary closure of the intraoral wound difficult to achieve. 4. Good oral hygiene and teeth bounding the alveolar ridge is not periodontally affected 1. Patients with any systemic disease that may affect normal healing 2. Patients with severely atrophic ridges requiring a staged grafting procedure. 3. Intra oral soft tissue defect that would affect the closure of the intra oral wound. 4. Patient with bad oral hygiene 17 Year(s) 50 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 09/07/2013 Ethics Committee of Scientific Research - faculty of oral and dental medicine ¿ Cairo university
Ethics Committee Address
Street address City Postal code Country
12 saray el manial street Cairo 11361 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome final vertical bone gain Immediate postoperative (1 week) and after 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
outpatient clinic of the oral and maxillofacial surgery department ¿ Cairo university 12 saray el manial street Cairo 11361 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funding 12 saray el manial street Cairo 11361 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Oral surgery depart. Cairo university 12 saray el manial st Cairo 11361 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ibrahim ezzat shindy 12 mesadak street, el doky Giza 11253 Egypt
Adel hamdy abou el fetouh 5 mesadak street , el doky Giza 11253 Egypt
Samy mounir shaker 38 abdalla abo el seoud street ,heliopolis Cairo 11366 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Samy MounirShaker mouniroma@hotmail.com 00201001505798 38 abdalla abou el seoud Heliopolis
City Postal code Country Position/Affiliation
Cairo 11366 Egypt Assistant Lecturer
Role Name Email Phone Street address
Public Enquiries Samy Mounir Shaker mouniroma@hotmail.com 00201001505798 38 abdalla abou el seoud Heliopolis
City Postal code Country Position/Affiliation
Cairo 11366 Egypt Assistant Lecturer
Role Name Email Phone Street address
Scientific Enquiries Samy Mounir Shaker mouniroma@hotmail.com 00201001505798 38 abdalla abou el seoud Heliopolis
City Postal code Country Position/Affiliation
Cairo 11366 Egypt Assistant Lecturer
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information