Computer Guided Split Thickness Versus Full Thickness Flap Buccal Bone Lid Approach in Hard Mandibular Pathosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorCairo University
About this trial
* Full thickness Buccal bone lid approach is well known and well reported technique with a superiority on preserving bone volume and better bone healing especially when done using piezoelectrical devices when compared to conventional technique for management of mandibular pathosis, however periosteum disturbance have a negative role regarding vascularity and bone healing, by comparing the split thickness VS full thickness flap design with buccal bone lid approach, this study will highlight if the periosteum preserved attached to the lid improve the healing on mandibular bony pathosis. * Aim of the study:
determine the effect of split thickness flap vs full thickness flap using a guided bone lid in hard mandibular pathosis in term of bone healing.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
No sex predilection.
Age: 18 to 40
mandibular intra-bony hard pathosis with a diameter ≥1cm with a buccal cortex thickness ≥1mm
Disqualifiers
Systemic or local disease/ condition that could affect bone healing
Diabetics
patients on systemic corticosteroid
chemotherapy
Trial design
Design model
Parallel
Treatments tested in this trial
computer guided split thickness flap for buccal bone lid approuch
Procedure/Surgery* After anesthesia administration, a split thickness flap will be elevated. * Guide will be seated according to the pre-planned position. * Periosteal incision will be performed following the external profile of the surgical guide. * The guide will be removed and minimum periosteal reflection will be done. * The guide will be placed again and the bone lid osteotomies will be prepared following the internal profile of the guide using piezoelectrical device. * The guide will be removed again, and the bone lid will be completed and detached with its attached periosteum. * The bony lid with its attached periosteum will be saved in saline solution until fixation. * Pathosis will be removed completely, and the lid will be returned and fixed to its original position using one or more screw. * Suturing with primary closure will be obtained. * Immediate post-operative CBCT will be taken
Treatment groups
26 Participants
are divided into 2 treatment groupsGroup A: computer guided full thickness flap for buccal bone lid approuch in hard mandibular pathosisActive comparator 1 intervention
Group B: computer guided split thickness flap for buccal bone lid approuch in hard mandibular pathosisExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
• bone defect filling
bone healing will be measured with Cone beam CT
Time frame
6 monthsSecondary outcomes
1
• Intra-operative time
Time frame
intra operative time needed for both techniques2
• Pain
• Pain will be measured by visual analogue scale VAS with 0 indicating no pain and 10 indicating the most severe pain. Patients will be asked to score the pain based on severity on the first, third, and seventh days
Time frame
first , third . 7th day post operative3
• Accuracy of transfer of the cutting guide
• Guide/osteotomy accuracy in millimeters, by superimposing the preoperative virtual guide outline based on the preoperative Cone Beam Computer Tomography (CBCT) and the immediate post operative actual osteotomy lines on postoperative CBCT
Time frame
immediate post operative using the post operative CBCTLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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