Clinical Trials Logo

Clinical Trial Summary

Insertion of a metal implant is considered one of the most common surgeries for fracture treatment, joint replacement, and dental implants. The success rate of these implants depends on their fixation which is in turn related primarily on the strength of the bone holding them. Studies evaluating the influence of local application of antiresorptive drugs, like bisphosphonates, on implanted endoprostheses whether orthopedic or dental is increasing annually with more and more experimental studies as well as clinical trials worldwide. On the other hand implants that release medications that enhance bone formation will lead to improved implant fixation and success. The objective of this study was to evaluate the effect of topical application of alendronate sodium gel and recombinant human bone morphogenic protein 2 on dental implant stability and crestal bone level.


Clinical Trial Description

Bisphosphonates (BPs), which are so called because they have two phosphonate (PO3) groups, are structurally similar to natural pyrophosphate (PP), a normal product of human metabolism that has a calcium chelating property. They are used to treat bone metastases, osteoporosis, Paget's disease, and other skeletal disorders.

During bone remodeling, osteoclast bone resorptive action is impeded by BPs which are released into the resorption lacunae. These cells take up BPs from resorption lacunae and the BPs then trigger the osteoclasts to undergo apoptosis. It has been found that an adjunct treatment of implant site with BPs solution might be beneficial to initial osseointegration of immediately or delayed loaded dental implants without interfering significantly with peri-implant bone remodeling over time.

Oral or intravenous administrations are the classical BPs treatment modalities with many studies show their positive effect on peri-implant bone. More efficient delivery systems to the target sites have been investigated to minimize BPs side effects and alter their biodistribution in order to improve their bioavailability; one of those new systems is topical application. Topical application of BPs enhances osseointegration, promote implant-bone contact and increase the amount of bone peripheral to dental implants. Minimal amounts of bisphosphonates was found to improve early implant fixation and to be less prone to cause osteonecrosis of the jaw, this might lead to new possibilities for orthopedic surgery in osteoporotic bones and for dental implants with a smaller risk of such complication in comparison with systemic treatment.

In order to maximize anabolism and minimize catabolism, new coating strategies have been evolved to enhanced bone formation onto the implant surface which is more desired than only reduce bone resorption around it. So to improve implant osseointegration, a dedicated drug-loading ability to locally target bone disorders has been developed to combine antiresorptive and anabolic agents, such as bone morphogenic protein, which for instance and in osteoporotic bone, will improve bone healing process.

With a view to diminishing the side effects caused by the systemic use of BPs, such as oesophagitis and osteonecrosis of the jaw, and to maximize anabolism and minimize catabolism, recent studies have sought alternative systems for local delivery of these agents with or without bone forming agent, either by means of immobilizing on the implant surface (coating or immersion in BPs solution), or by applying the drug directly to the surgical site before implant insertion either as an irrigant or gel. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04140006
Study type Interventional
Source University of Baghdad
Contact
Status Enrolling by invitation
Phase Phase 1/Phase 2
Start date July 1, 2019
Completion date July 1, 2020

See also
  Status Clinical Trial Phase
Completed NCT00713206 - Prospective Study of NanoTite Implants Placed Into Fresh Sinus-Lift Augmentation Sites (VSSL) N/A
Completed NCT03283241 - Zolidd One ExHex Dental Implant Compared to Uncoated One ExHex Dental Implant in Subjects With Partial Edentulism N/A
Completed NCT00728884 - Study of Certain Prevail Implants Used to Treat All Types of Edentulism in the Maxilla and Mandible
Completed NCT01529775 - Randomized Study of Osseotite Certain Tapered Prevails vs. Osseotite Certain Tapered N/A
Completed NCT03934853 - Study to Confirm Accuracy and Safety of the Inliant Surgical Navigation System N/A
Completed NCT03769376 - Histologic Comparison of Healing After Tooth Extraction With Ridge Preservation Using Two Different Xenografts N/A
Completed NCT01953991 - OHQoL With Removable Partial Dentures; a Pilot Study N/A
Completed NCT02387970 - Immediate or Delayed Provisionalization in Posterior Healed Sites N/A
Completed NCT02158377 - TM vs TSV Implants Loaded Early vs Conventional in Anterior and Posterior Areas N/A
Completed NCT01324778 - Multi Centre Study Comparing OsseoSpeed TX With OsseoSpeed N/A
Terminated NCT02188212 - Nobel Procera Crown Shaded Zirconia and NobelProceraTM Full Contour Crown IPS e.Max CAD N/A
Completed NCT00728962 - A Study of Osseotite Certain Prevail Implants Used to Support Short Fixed Bridges With Immediate Occlusal Loading.
Completed NCT00728754 - A Study of Certain Prevail Implants Used for the Preservation of Crestal Bone in Short Fixed Bridge Cases. N/A
Active, not recruiting NCT03558347 - CF41102 5-year Clinical Evaluation of Conelog® Implant With 7 mm Length N/A
Withdrawn NCT02590861 - Improving Oral Health Function With Implant Supported Partial Dentures N/A
Completed NCT02507661 - Effect of Alveolar Ridge Preservation on Implant Esthetic Outcomes Phase 4
Completed NCT02404649 - Comparing Conventional Dental Implants and Trabecular Metalâ„¢ Dental Implants After Sinus Floor Elevation N/A
Completed NCT02703168 - Long-term Performance of SLActive Implants After Immediate or Early Loading N/A
Completed NCT01529814 - Assessment of Integration Success of an Implant System With a Novel Abutment Attachment Design in Early Loaded Cases N/A
Completed NCT00782171 - Evaluation of Immediate Versus Delayed Loading of Dental Implants With a Modified Surface Phase 4