Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05193110 |
| Other study ID # |
A09091019 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 23, 2019 |
| Est. completion date |
December 28, 2021 |
Study information
| Verified date |
December 2021 |
| Source |
Mansoura University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This clinical trial demonstrates prosthetic management of patients complained from lack of
satisfaction and function of maxillary conventional complete denture as a result of severe
maxillary ridge resorption seeking for fixed restoration. They were attended to the
Department of Prosthodontics, Faculty of Dentistry, Mansoura University (Mansoura, Egypt).
They demonstrated sever bone loss especially in the posterior region which complicate
conventional implant placement for full arch prosthesis. Eight PEEK sub-periosteal implants
were surgically placed. Probing depth was measured after three & six months from
sub-periosteal implant placement. Tumor necrosis factor-alpha (TNF-α) & Interleukin-8(IL-8)
Peri-abutment cervicular fluid were measured one month, three months , six months & one year
from sub-periosteal implant placement. Clinical & Radiographic examination (CBCT) was done
two years after sub-periosteal implant placement.
Description:
Panoramic radiograph was done for each patient for diagnostic criteria, to evaluate condition
of the ridge and to be a base line for further radiographic follow up examination .
Fabrication of sub-periosteal implant was done as following: Computed tomography (CT) was
done for each patient while wearing the denture with radio opaque markers and saved as STL
file .CBCT was done for each denture and saved as STL file. Both STL files were aligned
together to obtain a complete virtual model of the patient with all information about bone,
soft tissue and the new prosthesis. This STL file then was processed and printed, in resin,
using powerful rapid prototyping machine. The sub-periosteal implant was designed virtually
on the virtual model by using dental wings(coDiagnostiXTM programme) .Location of the 4
abutments were designed to be on the canines and first molar region. Screws location were
designed to be on compact bone, anterior nasal spine, hard palate and zygomatic bone .Height
of the abutments were 5-6 mm..Thickness of the PEEK was 1.5 mm during construction and after
finishing and polishing become 1.2 mm The sub-periosteal implant was then saved as an STL
file, this file was first printed in resin to verify the accuracy of the fit on the 3D
printed model of the patient . Finishing and polishing was done by PEEK polishing sets then
the framework was decontaminated and packaged for sterilization by autoclave.
The surgery was done by a surgeon under local anaesthesia 4% Articaine with 1:100,000
epinephrine for hemostasis (articaine, Insiba, Spain) to the maxillary arch.The flap was done
using three incision lines. the crestal incision was performed at the crest of the ridge, Two
oblique releasing incisions were done at the distal ends of the crestal incision. Elevating
the flap was done by the mucoperiosteal elevator. Sub-periosteal PEEK implant was placed and
checked for its correct position, after placing the sub-periosteal implant, Fixation was done
by 2mm diameter Fixation screws(AntonHipp,Germany) to the peek framework and bone. Continuous
irrigation was done during drilling to avoid heat generation and bone necrosis. The flap was
closed while the 4 abutments projecting from the flap using 3/0 resorbable vicryl sutures
.1gm Amoxicillin was prescribed twice daily for every patient.Diclofenac potassium was
prescribed to relieve pain.Chlorohexidine mouth wash was prescribed to decrease inflammation
and swelling. Instruction was given to both patients for soft diet for 1 weak, cold
fomentations and not to move the check muscle strongly to avoid releasing of the sutures.
Patients were instructed to periodic recall every 2 week for 6 weeks. The implant was left
for healing then evaluation of soft probing depth around the abutments were done three months
& six months after surgical placement. For all surfaces Buccal(B), Palatal(P), Mesial(M),
Distal(D). (TNF-α) & (IL-8) Peri-abutment cervicular fluid was detected by paper points &
transferred to laboratory, specimens were evaluated by ELISA test one month ,three months ,
six months & 12 months after surgical placement. Clinical & Radiographic (CBCT) examination
was done after 2 years from sub-periosteal implant placement.
After complete healing of the soft tissue, preparation was done to the PEEK abutments under
copious irrigation with saline to avoid heat generation. Finishing and polishing of the PEEK
abutments were done by using composite polishing instruments. Impression was taken to the
maxillary arch using addition silicon impression material (Heavy and light body) in one step.
Proper vertical dimension was recorded, and then Face-bow transfer record was done to orient
the maxillary cast to the semi-adjustable articulator. Horizontal jaw relation was recorded;
centric inter-occlusal record was made. The mandibular denture was mounted on the articulator
using centric inter-occlusal wax record. PEEK framework was done for the abutments; Setting
up all the artificial teeth was made on the articulator. The maxillary PEEK framework with
teeth were tried in the patient's mouth then processed in to final prosthesis .Temporary
cement was used after insertion of the prosthesis to enable peri-implant probing depth &
cerivicular fluid evaluation then final cementation of the fixed prosthesis was done by DTK.
Strict oral hygiene measures & electric water jet irrigator tooth brush was instructed for
each patient
