Ridge Augmentation
Conditions
Brief summary
10 Patients having horizontally deficient anterior maxillary areas will be recruited and a preoperative CBCT will be done. The plan is to graft the defective ridges with simultaneously placing dental implants using a PEEK shell that will be specifically designed, constructed and 3D printed to act as a surgical guide for osteotomy drilling and implant placement as well as housing both the implant and the sticky bone (using a mixture of autogenous bone harvested from the symphysis area and xenograft both mixed with plasmatic matrix); that will be added to augment the defective ridge; the PEEK shell will also act as a barrier membrane for Guided Bone Regeneration and will add more stability to the placed implants that will be fixed to the PEEK shell occlusally with a Ti - based abutment. Primary stability will be measured using Ostell and an immediate postoperative CBCT will be done and superimposed on the preoperative CBCT and an accuracy of plan transfer will be measured to make sure the planning was followed accurately. Then 6 months later, another CBCT will be done to check the bone gain and quality and a second surgery will be done to remove the PEEK shell and proceed with the conventional implant prosthetic phase.
Interventions
PROCEDUREsticky bone housed in PEEK Shell
Patient specific Sticky Bone/Implant housing PEEK shell in Anterior Atrophic Maxilla
Sponsors
Cairo University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients with Multiple missing Maxillary Anterior Teeth with horizontally defective ridges having adequate soft tissue ample. * Patients who already gave their consent for this trial. * Males and females both will be included.
Exclusion criteria
* Patients on bisphosphonates or drugs altering bone metabolism, within 2 months before initiating the study. * Subjected to irradiation in the head and neck region within the last year * Patients allergic to drugs used in the study like ( Articaine, Lidocaine, * Patients having a history of a major medical condition (ASA 3,4) * Untreated periodontitis. * Poor oral hygiene and motivation. * Uncontrolled diabetes. * Pregnant or nursing. * Substance abuse. * Psychiatric problems or unrealistic expectations. * Severe bruxism or clenching. * Immunosuppressed or immunocompromised. * Treated or under treatment with intravenous amino-bisphosphonates. * Active infection or severe inflammation in the area intended for implant placement. * Unable to open mouth sufficiently to accommodate the surgical tooling. * Patients participating in other studies, if the present protocol could not be properly followed. * Referred only for implant placement or unable to attend a 5-year follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone gain | T0 before surgery, T1 immediately after surgery and T2 after 6 months | Serial CBCT images (T0 before surgery, T1 immediately after surgery and T2 after 6 months) measuring bone gain in mm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinically successful osseointegrated implant | At the day of the surgery and 6 months after first surgery | measuring primary stability immediately after implant placement and in the second surgery using Ostell device |
| Accuracy of Plan Transfer | 1-3 days postoperatively | superimposing the preoperative CBCT and the immediately postoperative CBCT to measure the accuracy of the procedure compared to the plan done |
| Bone Quality | 0 before surgery, T1 immediately after surgery and T2 after 6 months | Serial CBCT images (T0 before surgery, T1 immediately after surgery and T2 after 6 months) measuring bone quality in Hounsfield units |
Countries
Egypt
Contacts
Primary ContactMohamed MS Bahgat, BDS
Outcome results
None listed