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.: PACTR202402846281250 Date of Approval: 02/02/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluation of the Resection plane three-dimensional positional accuracy using a Resection Guide Directional Guidance slot. A randomized clinical trial.
Official scientific title Evaluation of the Resection plane three-dimensional positional accuracy using a Resection Guide Directional Guidance slot. A randomized clinical trial.
Brief summary describing the background and objectives of the trial Background: Patients with malignant and benign disease abutting or invading the mandible often undergo segmental resection of the mandible. To restore continuity of the mandible and associated function and aesthetics, reconstruction with a titanium plate in combination with an osseous free flap is performed in the majority of cases (1,2). The resection planes of the involved part of the mandible must be determined accurately to ensure adequate and free margins, but also to allow precise placement of bone segments, enabling the contour of the neomandible to match the native resected mandible (1,2). The exact location of the resection planes, as well as the reconstruction after resection, can be prepared with virtual surgical planning (VSP) (3). Using this technique, three-dimensional (3D) rendered models of the mandible and graft are constructed from a preoperative computed tomography (CT) scan. The 3D models are used to perform a virtual (segmental) mandibulectomy and to virtually segment the graft to match the defect. To translate the position of the resection planes from the virtual surgical plan to the clinical situation in the operating room, patient-specific cutting guides and fixation plates are designed and manufactured using computer-aided design/computer-aided manufacturing (CAD/CAM) techniques. These cutting guides enable the surgeon to perform the surgical procedure more accurately, while significantly shortening the operating time (4–6). Postoperative CT imaging has been used to verify how precise the virtual surgical plan has been translated during surgery. Several studies have evaluated the accuracy of translation by comparing the location and orientation of the planned resection plane with the plane of the actual osteotomy performed. El-Mahallawy et al. introduced a landmark based postoperative accuracy assessment methodology to get the deviation of the actual postoperative outcome from the virtual plan (7). De Maesschalck et al. and Roser et al. used a s
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial accuracy of computer assisted surgery
Anticipated trial start date 01/09/2023
Actual trial start date 01/09/2023
Anticipated date of last follow up 31/10/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 14
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 randomization using a randomization table created by a 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 Computer assisted mandibular resection using a resection guide with no directional guidance slot during surgery Computer assisted mandibular resection using a resection guide with no directional guidance slot 7 Active-Treatment of Control Group
Experimental Group Computer assisted mandibular resection using a resection guide with directional guidance slot during surgery Computer assisted mandibular resection using a resection guide with a directional guidance slot 7
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients with segmental mandibular continuity defect, not involving the condyle. 2. Patients suffering from lesions that are invasive to the lower border of the mandible. 3. Patients dealing with osteomyelitis that’s indicated for sequestrectomy. 1. Medically compromised patients contradicting operation 2. Patients with a composite mandibular defect with soft tissue deficiency after resection. 3. Patients with lateral segmental mandibular defect involving the condyle. 4. Patients with an active infection at the site of resection. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 1 Year(s) 70 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 24/09/2023 the scientific research ethics committe at the faculty of dentistry Alexandria university
Ethics Committee Address
Street address City Postal code Country
champlion st, Azarita Alexandria 21523 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Accuracy of Mandible Resection-Osteotomy Guides immediate postoperative
Secondary Outcome Accuracy of the Planned Bone Graft/flap Position immediate postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
alexandria university teaching hospital Chmplion st, Azarita Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
yehia ahmed smouha Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of dentistry Alexandria university champlion st, Azarita Alexandria Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Yehia Elmahallawy yehia.el-mahallawy@alexu.edu.eg +2034226087 Smouha
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer
Role Name Email Phone Street address
Principal Investigator Haytham AlMahalawy Has05@fayoum.edu.eg 01007217014 smouha
City Postal code Country Position/Affiliation
alexandria Egypt Associate Professor of Oral and Maxillofacial Surgery
Role Name Email Phone Street address
Public Enquiries Noha Dessoky dr_nohayoussry@hotmail.com +201270060160 346 st
City Postal code Country Position/Affiliation
Alexandria Egypt lecturer of Oral and Maxillofacial Surgery
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification will be available (including data dictionaries) Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date Anyone who wishes to access the data for Any purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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