Initial Stability of Posterior Maxillary Implants With Bicortical Fixation
| Status: | Completed |
|---|---|
| Conditions: | Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/13/2018 |
| Start Date: | September 2010 |
| End Date: | October 2018 |
Comparison of Initial Implant Stability of Posterior Maxillary Implants With Bicortical Fixation to Implants Engaging Only the Alveolar Crest
The primary purpose of this study is to
1. determine whether dental implant engaging both the alveolar crest cortical bone and
sinus floor using vertical stopper drill and self-threading concept (bi-cortical
fixation) increases initial implant stability compared to the short implants engaging
only alveolar crest cortical bone (uni-cortical fixation) and/or ones engaging both
crest and sinus floor but with green stick fracture (indirect sinus lift technique),
2. study whether different surgical techniques, residual bone height, bone density, and
length and width of the implants used affect initial implant stability in posterior
maxilla. In addition, this study will continue to
3. compare secondary implant stability of implants fixed bi-cortically, uni-cortically and
with indirect sinus lift technique at 2nd stage surgery/6 month healing and 1 year
follow-up from the restoration and
4. measure amount of endo-sinus bone formation from the 1- year follow up CT (computer
tomogram) scan and evaluate safety and potential post-operative complications of
bi-cortical fixation and indirect sinus lift technique reported throughout the follow up
periods.
1. determine whether dental implant engaging both the alveolar crest cortical bone and
sinus floor using vertical stopper drill and self-threading concept (bi-cortical
fixation) increases initial implant stability compared to the short implants engaging
only alveolar crest cortical bone (uni-cortical fixation) and/or ones engaging both
crest and sinus floor but with green stick fracture (indirect sinus lift technique),
2. study whether different surgical techniques, residual bone height, bone density, and
length and width of the implants used affect initial implant stability in posterior
maxilla. In addition, this study will continue to
3. compare secondary implant stability of implants fixed bi-cortically, uni-cortically and
with indirect sinus lift technique at 2nd stage surgery/6 month healing and 1 year
follow-up from the restoration and
4. measure amount of endo-sinus bone formation from the 1- year follow up CT (computer
tomogram) scan and evaluate safety and potential post-operative complications of
bi-cortical fixation and indirect sinus lift technique reported throughout the follow up
periods.
The clinical trial will evaluate initial implant stability as a primary outcome measured by
resonance frequency analysis (RFA) employing dental implants surgically placed in posterior
maxillary bone by engaging alveolar crest and the sinus floor using vertical stopper drill
and self-threading concept (bi-cortical fixation), engaging only the alveolar crest
(uni-cortical fixation), and engaging alveolar crest and the sinus floor using indirect sinus
lift technique (indirect sinus lift technique). The surgical procedures compared in this
experiment include 3 groups:
- Group 1 (15 implants) Short implants placed in proximity of the sinus without sinus
floor involvement (unicortical fixation)
- Group 2 (15 implants) Implants placed using indirect sinus lift technique (indirect
sinus lift technique)
- Group 3 (15 implants) Bi-cortically fixed implants intentionally engaging sinus floor
beyond up to 1-2mm without graft but using stopper drill and self-threading concept
(bi-cortical fixation)
resonance frequency analysis (RFA) employing dental implants surgically placed in posterior
maxillary bone by engaging alveolar crest and the sinus floor using vertical stopper drill
and self-threading concept (bi-cortical fixation), engaging only the alveolar crest
(uni-cortical fixation), and engaging alveolar crest and the sinus floor using indirect sinus
lift technique (indirect sinus lift technique). The surgical procedures compared in this
experiment include 3 groups:
- Group 1 (15 implants) Short implants placed in proximity of the sinus without sinus
floor involvement (unicortical fixation)
- Group 2 (15 implants) Implants placed using indirect sinus lift technique (indirect
sinus lift technique)
- Group 3 (15 implants) Bi-cortically fixed implants intentionally engaging sinus floor
beyond up to 1-2mm without graft but using stopper drill and self-threading concept
(bi-cortical fixation)
Inclusion Criteria:
- Eligible volunteers must be at least 18 years old, partially edentulous in maxillary
posterior region with 7-11 mm residual bone height under the sinus floor and be
indicated for CBCT scan for diagnosis and treatment planning, and of a medical risk of
ASA I or II classification to participate.
Exclusion Criteria:
- Patients with bone pathology, sinus infection, and who are pregnant will be excluded.
Implants requiring tapping, site of an implant replacement, and implant with
dehiscence and/or fenestration will be excluded.
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