Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06221306 |
| Other study ID # |
blt |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 2024 |
| Est. completion date |
April 2026 |
Study information
| Verified date |
February 2024 |
| Source |
Cairo University |
| Contact |
Suzy Naiem, MSc |
| Phone |
+201224785645 |
| Email |
suzy.naiem[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Dental implant treatment, in many cases, may be impeded by anatomical limitations, such as
narrow atrophic ridges. In order to overcome that, additional surgical procedures, such as
guided bone regeneration, are often required to augment the deficient hard tissue. However,
additional surgical procedures often add morbidity to the patient in addition to prolonging
the treatment time and raising the treatment cost.
Hence, simpler, less invasive treatment options are preferred by patients. The use of narrow
diameter implants (NDI) offers the great advantage of eliminating the need for augmentation
procedures.
Description:
Various methods of additional surgical procedures have been introduced to overcome reduced
bone volume situations, relevant to the site, size and nature of the defect such as:
maxillary sinus floor lifting and augmentation, vertical and lateral ridge augmentation by
means of autogenous or bone substitutes, particulate or blocks. Lateral bone augmentation
performed simultaneously with implant placement has been a well-established treatment option
for horizontal ridge deficiencies.
Such additional procedures are associated with longer surgical time, greater morbidity and
greater risk to complications such as: pain, infection, nerve damage, bleeding, wound
dehiscence or even graft or implant failure. In addition to, higher treatment cost and a
longer healing time. Furthermore, an additional surgical procedure should be considered with
caution in medically compromised patients. Moreover, surgical expertise of the operator is
required for performing such procedures.
NDIs showed promising results with reported survival rates 95% - 100%. However, prosthetic
complications such as: abutment fracture, loss of crown retention and screw loosening were
reported.
The successful outcomes of NDI have supported widening the scope to include premolars and
molars, particularly where averting an additional augmentation procedure is favoured.
However, areas of concern remain evident regarding; the impact of loading on a reduced
surface for osseointegration, the increased probability of fracture, the probable prosthetic
complications and the loading stresses affecting crestal bone resorption. In addition to oral
health-related quality of life for the patients. Limited literature is found regarding the
use of NDI to restore posterior mandibular edentulous sites.
Several studies have compared NDI to SDI in pristine bone. To our knowledge few RCTs compared
NDIs to SDI with simultaneous lateral bone augmentation for the treatment of atrophic
posterior mandibular ridges, none assessing both crestal bone resorption in addition to oral
health related quality of life (OHRQoL) assessment.
