Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01060644 |
| Other study ID # |
CMC-08-0015-CTIL |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
January 31, 2010 |
| Last updated |
November 20, 2013 |
| Start date |
March 2011 |
| Est. completion date |
January 2013 |
Study information
| Verified date |
November 2013 |
| Source |
Carmel Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Institutional Review Board |
| Study type |
Observational
|
Clinical Trial Summary
The present study describes and evaluates the surgical protocol for sinus mucosal lining
elevation of the maxillary sinus for Dental Implant Insertion without Bone grafting
Underneath the Sinus Membrane.
Description:
Restoration of lost dentition in the severely atrophic posterior maxilla has for the last 2
decades been successfully treated with various sinus augmentation techniques and
installation of dental implants. The use of graft material is anticipated to be necessary;
however, recent studies have demonstrated that the mere lifting of the sinus mucosal lining
and simultaneous placement of implants result in bone formation. This study was conducted in
order to evaluate simultaneous sinus mucosal lining elevation and installation of dental
implants without any graft material.
The present study describes and evaluates a modification of the surgical protocol for sinus
mucosal lining elevation and simultaneous installation of osseointegrated implants with a
MIS implant system (Seven ™) ,in 20 patients.
Preoperative Examination: (Screening):
1. Medical History
2. Clinical Examination
1. Oral hygiene.
2. Oral mucosa condition.
3. Number of missing teeth in the posterior maxilla.
3. Radiographic Examination (CT and Panoramic X-ray)
1. Sinus Maxillary condition.
2. Sub-antral bone height.
3. Bone jaw condition. Selected patients under the "inclusion criteria" will be
included in the study after they will have explanation and signed on informed
consent.
Surgery:
All patients will be operated on under local anesthesia (2% Xylocaine Dental with
epinephrine 1:100,000;) or General anesthesia ( the type of the anesthesia will be decided
by the patients) at Carmel medical center Haifa.. Preoperative antibiotics will orally
administered 45 minutes before surgery; patients routinely received 2 g of Augmentin or 600
mg of clindamycin (when allergic to penicillin).and 6mg of Dexamethasone 1 hour before
surgery.
Surgical Technique:
The posterior maxillary edentulous area and the maxillary sinus wall will be exposed via a
crestal incision and a buccal muco-periosteal flap will be raised. Osteotomy in a oval or
rectangular fashion will be made with round Drill 5 mm radius in the anterior wall of the
sinus, 5 to 6 mm cranial to the intended implant site (Fig 1). With small sharp elevators
the cortical bony window will be pulled in the sinus cavity.
Perforations of various sizes of the sinus mucosal lining will be treated by drilling small
holes in the bone above the cortical window to elevate and suture the mucosal lining to that
level using absorbable sutures (Vicryl 6-0). If there is success in this technique we will
use a small piece of periosteum (taken from the buccal flap) which will be placed as a lid
over a perforation of the sinus mucosal lining. If the perforations are so small (less than
1 mm) then further dissection of the mucosal lining and "tenting" by the implants will be
considered satisfactory for a blood clot to form around the implants.
After the elevation, implants will be installed in the residual sub-antral bone. The
remaining bone height will be recorded with a depth gauge during surgery. Primary implant
stability will be noted manually at installation. A stabilizing wrench will be used when
removing the implant carrier in all cases.
To achieve implant stability in the cases of small remaining levels of vertical subantral
bone, the protocol of installing the MIS system dental implant was modified in its last
preparation step. The final conical burr was leveled into the bone 1 to 2 mm less than the
recommended standard protocol in cases with only 2 to 3 mm residual bone. Thus, a slightly
smaller hole for the implant was prepared and the implant could be placed with better
primary stability, utilizing the effect of the conical design and the retention of the
microthreads in the superior part, adding an extra effect to the placement and thereby
achieving sufficient primary stability. The compartment around the implants under the sinus
mucosal lining in the sinus floor will be filled with blood from surrounding bleeding (Fig
2), and dental membrane (Zimmer Ltd.) will be placed on the open window, then the incision
will be closed with resorbable sutures (Vicryl 3/0. Ethicon Inc
Postoperative Care:
Analgesics will be prescribed with Optalgin or with a nonsteroidal anti-inflammatory drug
for 1 to 2 weeks following the surgery. Antibiotic treatment will be continue for 10 days
postoperatively with Augmentin 875mg Twice a day (or clindamycin, 300 mg 3 times daily for
penicillin allergic patients). Patients should be instructed not to blow their nose and to
use nasal spray saline for 14 days after surgery. Wearing dentures will not be allowed for
10 days following the surgery.
Patients will be reviewed and sutures taken out after 7 to 10 days. Clinical and
Radiological Follow-up The patient will be recalled to the out patient clinic in Carmel
Medical Center, for a follow up. All patients will be checked in the surgery site and x-ray
radiograph will be made.
Radiological follow up:
Periapical radiographs and Panoramic X-ray will be used for measurements of 1) the height of
the residual alveolar bone at each implant site, and 2) the height of newly formed bone in
the maxillary sinus in relation to each implant. Measurements will be made manually with a
millimeter scale. The cervical micro-threaded area of the implant will be used as a
reference point during measurement.
Criteria for considering the procedure as successful:
1. Successful implants ( no pain, no infection, stable implants) at the uncovering
procedure.
2. Periapical and panoramic x-ray at the endpoint shows a bone formation around the
implant inside the maxillary sinus.
Uncovering of the implant will be done 6 month after the surgery. All patients will be
operated on under local anesthesia (2% Xylocaine Dental with epinephrine 1:100,000;) the
implant instillation area and the maxillary sinus wall will be exposed via a crestal
incision and a buccal mucoperiosteal flap will be raised.
1. A healing cap will be inserted in the implant.
2. A punch of 2mm biopsy will be take from the maxillary wall. The incision will be closed
with resorbable sutures (Vicryl 3/0. Ethicon Inc) around the healing cap.
The referring dentists will carried out the prosthetic rehabilitation after two weeks for
the uncovering procedure. All patients will be recalled for follow up after the prosthetic
rehabilitation 2 and 4 months in our out patients clinic.
Statistics Descriptive statistics will be used and the correlation of results will be
confirmed with linear regression analysis.
