Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
Study NCT ID:
NCT06221306
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2023-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Crestal Bone Loss Around Narrow Diameter Implants Versus Standard Diameter Implants With Bone Augmentation in Horizontally Deficient Posterior Mandibular Sites.
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Radiographic Evaluation of Crestal Bone Loss Around Narrow Diameter Implants Versus Standard Diameter Implants in Conjunction With Bone Augmentation in Horizontally Deficient Posterior Mandibular Partially Edentulous Sites: A Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: