Partial Edentulism Clinical Trial
Official title:
Evaluation of Topical Application of Alendronate Sodium In-situ Gel and Recombinant Human Bone Morphogenic Protein 2 on Dental Implant Stability and Crestal Bone Level: A Randomized Controlled Clinical Study
Verified date | October 2019 |
Source | University of Baghdad |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Iraq | College of dentistry, University of Baghdad | Baghdad | Bab-Almoadham |
Lead Sponsor | Collaborator |
---|---|
University of Baghdad |
Iraq,
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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