Tufts University School of Dental Medicine. Oregon Health and Science University. Washington University School of Medicine. University of Connecticut Health Center. CaroMont Regional Medical Center. Comprehensive Cancer Centers of Nevada - Henderson. University of Maryland, School of Dentistry. University of California at Los Angeles. The Christ Hospital. Colorado Cancer Research Program.
Providence Regional Cancer Partnership. University of Iowa Hospitals and Clinics. Willis Knighton Cancer Center. East Carolina University. Florida Hospital.
University of Iowa. University of Michigan School of Dentistry. Vanderbilt University Medical Center. University of Washington, School of Dentistry. Stanford University. Connecticut Children's Medical Center. University of Miami. Federal Correction Institution Butner. Graduate Endodontic Clinic. Harvard School of Dental Medicine.
Marc Lemchen. Nemours Children's Specialty Care, Jacksonville. University of North Carolina at Chapel Hill. University of Minnesota School of Dentistry. The University of California Irvine. A stiffer material theoretically gives possibilities for implants installations without bone augmentation in cases with reduced bone volumes.
An alternative implant material which has reached the clinic is titanium-zirconium alloy. It has been shown to have an increased rigidity in comparison with titanium and comparable biological characteristics but the documentation consists mainly of animal studies and short term clinical follow-up in the form of case-series.
Since it has been demonstrated that the choice of implant material may influence osseointegration, it is necessary to evaluate the implants made of titanium-zirconium in a clinical controlled study with long-term follow-up in which the emphasis is put on the clinical outcome.
The aim of the study is to compare the clinical outcome of implants made of titanium-zirconium with a proven implants made of titanium. The scientific question in this project is if there are differences in the clinical outcomes of an implant made of titanium and a corresponding implants in titanium-zirconium alloy. Two groups, matched for age and gender, will be defined after block randomisation for smoking. The test group will receive titanium-zirconium implants and the control group titanium implants.
The data collection is completed when the number of patients has been reached. The evaluation will involve no additional clinical or radiological examinations as compared to the usual procedures. No additional time or costs arises in connection with participation in the study, the cost of both groups are equivalent. National guidelines will be followed regarding possible need of antibiotic prophylaxis. Registration will be done with regard to history of periodontal disease, smoking, medication, and implant position in the jaw.
The data collection will take place at four different times: in connection with the placement of the prosthetic construction baseline and after 1. Standard x-ray examinations will be carried out to check the marginal bone level which will take place through individualized x-ray holders that will be produced by impression material Putty.
Registration of pocket depth, bleeding on probing, amount of keratinized mucosa and measurements on x-ray will be done by the same person. Prosthetic complications and possible total implant loss will be registered. The marginal bone level for each implant will be presented as the average of the mesial and distal bone level primary outcome. The mean value of pocket depth will be recorded for each implant at a 4-point measurement.
The hypothesis is to be tested with the independent samples t-test. The impact of restoration distance from the bone level, the effect of implant type, margin bone level, bleeding on probing and pocket depth will be controlled using regression analysis.
SPSS is used for statistical analysis. The hypothesis is that there are no differences in the clinical outcomes between the two types of implants. The investigators can conclude that the materials are equivalent if there is no difference between implant types available.
Since, titanium-zirconium alloy has a higher stiffness than titan, the investigators will be able to provide patients with thinner implant and thus costly and painful treatments to optimize the width of the bone in the installation area should be avoided.
From a social perspective, if it turns out that titan-zirconium have equal or better clinical performance than titanium, can unnecessary healthcare costs for surgery for modulation of the surgical site in the form of augmentation or sinus elevation associated with implant treatment should be avoided.
If optimizing surgery can be avoided, this means even shorter therapy times and increased availability by the released health time which can be used to more quickly treat other patients as possible had standing in line for their treatment. Limits can be found in the study's applicability in general dentistry because all operations are carried out at specialist clinic in which case the patient clientele and the processor's level of expertise is not fully comparable with the general dentist.
Treatment with dental implants in titanium is a known treatment that has helped to restore good chewing function for many patients and years all over the world and can be thought of as a safe treatment with high success rates. The study protocol calls for no difference in the x-ray examination or the surgical protocol as compared to the procedures followed in regular treatment basis.
In previous studies, there is no listing of suspected allergy to titanium-zirconium alloy. Patient information and storage of personal data in accordance with the recommendations of the Board of ethical review. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Try the modernized ClinicalTrials.
Learn more about the modernization effort. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.
Search for terms. Save this study. Warning You have reached the maximum number of saved studies A Clinical Trial of Dental Implants in Titanium-zirconium Alloy The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Mary L. Coe ppdi.
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