Efficacy of Antiresorptive and Bone Forming Material on Dental Implants

Phase 1

• Conditions: Partial Edentulism
• Interventions: Drug: Control; Drug: BMP Gel; Drug: ALN Gel; Drug: Mixed Gel

• Registration Number: NCT04140006
• Lead Sponsor: University of Baghdad

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2019-06-26
• Study Start: 2019-07-01
• Status Verified: 2019-10
• Study First Submitted QC: 2019-10-24
• Last Update Submitted: 2019-10-24
• Study First Posted: 2019-10-25
• Last Update Posted: 2019-10-25
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Control	Control	After preparation, the fixture will be inserted without topical application of any medication (20 fixtures)
Bone Morphogenic Protein Gel (BMP)	BMP Gel	After preparation, 0.05 ml of the gel containing 100 µg of BMP will be injected in the osteotomy site immediately before fixture insertion (20 fixtures)
Alendronate Gel (ALN)	ALN Gel	After preparation, 0.05 ml of the gel containing 100 µg of ALN will be injected in the osteotomy site immediately before fixture insertion (20 fixtures)
Mixture Gel of ALN and BMP	Mixed Gel	After preparation, 0.05 ml of mixture gel containing 50 µg of ALN and 50 µg of BMP will be injected in the osteotomy site immediately before fixture insertion (20 fixtures)

Primary Outcome Measures

Name	Time	Method
Implant stability	12 weeks post loading	Mean implant stability between different comparators following implants loading by using resonance frequency analysis scaled from 1 to 100
Crestal bone level	12 weeks post loading	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

Secondary Outcome Measures

Name	Time	Method
Bone density around dental implant	12 weeks post loading	Mean difference in bone density around dental implants between different comparators following implants loading by using cone beam computerized tomography with hounsfield unit

Trial Locations

Locations (1)

College of dentistry, University of Baghdad; 🇮🇶 Baghdad, Bab-Almoadham, Iraq