Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06089928 |
| Other study ID # |
segmental osteotomy |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2024 |
| Est. completion date |
January 30, 2026 |
Study information
| Verified date |
October 2023 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The atrophatic anterior maxilla present a considerable challenge for both surgical and
prosthetic rehabilitation, as it may require bone augmentation to enable implant placement.
The techniques proposed for vertical augmentation of the alveolar ridge include distraction
osteogenesis, only grafting, and sandwich osteoplasty. Sandwich osteotomy is reported to
provide more stable and predictable results with respect to the height of the alveolar ridge.
The main advantage of osteotomy techniques that employ Interpositional bone grafts is
reported to be the improved blood supply in the augmented region.
Description:
the investigators aim to evaluate the radiographical, clinical differences of newly formed
bone following vertical maxillary ridge augmentation using sandwich inlay with autogenous
bone block from the rums without fixation (study group I) compared to same procedure with
fixation (micro plates and screw) (control group).
description of intervention:
1) diagnostic procedure:
- All Participant will be selected according to inclusion and exclusion criteria.
- Comprehensive clinical examination and understanding of patient's chief complaints will
be carried out.
- All participants will be informed about the surgical treatment procedure and will
provide their written consent to participate in the study.
- Preoperative panoramic radiograph will be requested prior as general screening for any
pathosis and primary maxillary anterior residual bone height assessment.
- A (CBCT) scan will be requested for each patient to confirm amount of horizontal and
vertical bone, to exactly measure the amount of bone height and to plan and guide
surgical procedures of block graft.
- Alginate Impressions of upper & lower jaws will be taken for acquiring diagnostic dental
casts.
intra-surgical procedure :
Harvesting procedures of the mandibular ramus block graft:
After administering local anesthesia, a soft tissue incision will be made in the posterior
mandible to create an envelope flap similar to that created in a third molar extraction, with
an external oblique incision extending anteriorly into the buccal sulcus of the respective
molar sites. A mucoperiosteal full-thickness flap will be then reflected with a sharp
periosteal elevator, exposing the lateral aspect of the ramus. Osteotomies to take ABB will
be performed in the ramus using trephine drills. The size of the block depended on the size
of the graft needed. The size of the graft will be adjected with diamond discs under saline
irrigation. Donor sites will be closed after the bone graft procedure will be completed.
Recipient site preparation:
Following the administration of local anesthesia, a soft tissue incision will be performed.
After a full-thickness mucoperiosteal flap will be reflected, the alveolar bone exposed. The
edentulous area and the residual bone ridge will be prepared carefully to receive the bone
graft; the defect dimensions will be measured with a periodontal probe to determine the
approximate size of the block graft to be harvested or amount of particle bone graft needed.
Three full-thickness bony cuts will be performed. Two vertical stop cuts will be made using a
tungsten carbide disc at the distal ends of the mid-crestal bony cut on the facial surface of
alveolar ridge; the vertical cuts will be 3 mm from the neighboring teeth. The
above-described cuts will be revised using ridge-splitting osteotomes (fine chisels) of
sequential width (2 mm, 3 mm) and a lightweight mallet. The rectangular bony segment
(transport segment) will be mobilized occlusally and be pedicled on the palatal
mucoperiosteum. The autogenous blocks will be fitted between the mobilized segment and the
basal bone, and the remining gap will be filled with particulated autogenous bone, in test
group; there is no mean of fixation will be used while in the control group the segment will
be fixed using micro-plates and screws. Scoring will be done to allow tension-free closure.
