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.: PACTR201305000527245 Date of Approval: 05/04/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Computer-guided mandibular segmental resection and immediate reconstruction using patient specific titanium devices versus conventional techniques: R
Official scientific title Computer-guided mandibular segmental resection and immediate reconstruction using patient specific titanium devices versus conventional techniques: Randomized Control clinical trial.
Brief summary describing the background and objectives of the trial The rehabilitation of patients affected by defects of the mandible after tumor resection is still very challenging. Resection can lead to significant facial deformity, impaired oral functions such as speech, swallowing, saliva retention, and concomitant psychological problems. Moreover, the loss of teeth and the alveolar and basal jaw bone can lead to significant impairment of mastication. There are different methods of reconstruction of such defects. Autogenous bone grafts or revascularized fr
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,Mandibular tumors requiring segmental resection,Oral Health,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 10/06/2013
Actual trial start date 22/04/2013
Anticipated date of last follow up 02/06/2014
Actual Last follow-up date
Anticipated target sample size (number of participants) 10
Actual target sample size (number of participants) 10
Recruitment status Not yet 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 Sealed opaque enbvelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Computer-guided segmental resection Once Immediate segmental mandibular reconstruction using 3D patient specific titanium device 5
Control Group Immediate reconstruction using reconstruction plates Once Immediate segmental mandibular reconstruction using reconstruction plates 5 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Patients with benign or locally agressive Lesions affecting mandible that requires segmental resection. ¿ Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome. ¿ No intraoral soft tissue defect that would render primary closure of the intraoral wound difficult to achieve. ¿ Patients with any systemic disease that may affect normal healing ¿ Patients with any malignant lesions affecting the mandible requiring composite resection ¿ Intra oral soft tissue defect that would affect the closure of the intra oral wound. 5 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
No 11/03/2013 Ethics Committee of Scientific Research
Ethics Committee Address
Street address City Postal code Country
Cairo University Cairo Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Soft tissue contour and bilateral symmetry Numerical Score Millimeters from the midline
Primary Outcome Intraoperative Time Minutes
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo Univ Maxillofacial Surg Department Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Mounir Ahmed 38 Abdulla Aboul seoud (Heliopolis Cairo 11361 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Mohamed Mounir Ahmed 38 Abdulla Aboul seoud (Heliopolis Cairo 11361 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr Raggia Mohamed Nounir Cairo University Cairo Egypt
Dr Waleed Ragab EL Beialy Cairo University Cairo Egypt
Dr Adel Hamdy Abou el-Fetouh Cairo University Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Mounir Ahmed mouniroma@hotmail.com (002)01001505798 38 Abdulla Aboul seoud (Heliopolis)
City Postal code Country Position/Affiliation
Cairo 11361 Egypt
Role Name Email Phone Street address
Public Enquiries Mohamed Mounir Ahmed mouniroma@hotmail.com (002)01001505798 38 Adbdulla Aboul seouf (Heliopolis)
City Postal code Country Position/Affiliation
Cairo 11261 Egypt
Role Name Email Phone Street address
Scientific Enquiries Mohamed Mounir Ahmed mouniroma@hotmail.com (002)01001505798 38 Adbdulla Aboul seouf (Heliopolis)
City Postal code Country Position/Affiliation
Cairo 11261 Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information