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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04140006
Other study ID # 034118
Secondary ID
Status Enrolling by invitation
Phase Phase 1/Phase 2
First received
Last updated
Start date July 1, 2019
Est. completion date July 1, 2020

Study information

Verified date October 2019
Source University of Baghdad
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 20
Est. completion date July 1, 2020
Est. primary completion date July 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria Otherwise healthy patients over 18 years or with systemic diseases that do not interfere with bone healing Having single or multiple missing teeth in maxilla and/or mandible Having an alveolar ridge of sufficient vertical and horizontal dimensions and considered straightforward cases according to SAC classification

Exclusion criteria Patients with active or chronic infection or inflammation in the implant zone History of radiotherapy to the head and neck Past or current treatment with oral/intramuscular/intravenous bisphosphonates or other drugs altering bone metabolism Heavy smokers or with sever periodontitis

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ALN Gel
Flapped surgery for insertion of dental implant with topical application of ALN gel
BMP Gel
Flapped surgery for insertion of dental implant with topical application of BMP gel
Mixed Gel
Flapped surgery for insertion of dental implant with topical application of mixed gel of ALN and BMP
Control
Flapped surgery for insertion of dental implant without topical application of any gel

Locations

Country Name City State
Iraq College of dentistry, University of Baghdad Baghdad Bab-Almoadham

Sponsors (1)

Lead Sponsor Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type Measure Description Time frame Safety issue
Primary Implant stability Mean implant stability between different comparators following implants insertion by using resonance frequency analysis scaled from 1 to 100 8 weeks
Primary Implant stability Mean implant stability between different comparators following implants insertion by using resonance frequency analysis scaled from 1 to 100 12 weeks post surgery
Primary Implant stability Mean implant stability between different comparators following implants loading by using resonance frequency analysis scaled from 1 to 100 12 weeks post loading
Primary Crestal bone level Mean crestal bone level between different comparators following implants insertion by using cone beam computerized tomography measured from the first bone implant contact by millimeters 12 weeks post surgery
Primary Crestal bone level Mean crestal bone level between different comparators following implants loading by using cone beam computerized tomography measured from the first bone implant contact by millimeters 12 weeks post loading
Secondary Bone density around dental implant Mean difference in bone density around dental implants between different comparators following implants insertion by using cone beam computerized tomography with hounsfield unit 12 weeks post surgery
Secondary Bone density around dental implant Mean difference in bone density around dental implants between different comparators following implants loading by using cone beam computerized tomography with hounsfield unit 12 weeks post loading
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