- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04378140
Retention and Durability of the Anterior Zirconia Wing Bridge
This study is a clinical trial to determine the retention and durability of the anterior zirconia wing bridge. The type of zirconia-wing bridge the investigators are researching in this study has two wings which generally have three countersunk holes (meaning that the circumference of the outer portion of the hole is larger than the inner part of the hole). Composite resin (dental filling material) is placed in the holes as well as under and around the wings.
Twelve patients will have bridges placed and be evaluated every 6 months (ideally) to determine if the bridge is staying in place (retention) and if it is resistant to fracture (durability).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
For patients missing an anterior tooth, the treatment options available include a dental implant, a removable partial denture, or a bridge. Some patients may not desire an implant due to the surgical nature, the limited bone available or the high cost. Removable partial dentures are relatively inexpensive but are undesirable for many patients due to the limited esthetics, trouble speaking and annoyance of an oral prosthesis. Traditional bridges use adjacent teeth as abutments and replace the missing tooth. However, these require the removal of 1-2 mm of tooth structure on adjacent teeth provide room for the porcelain of the bridge.
Decades ago, the option for a conservative bridge was primarily found in the Maryland bridge, which had two metal wings that were cemented or bonded on to two abutments. Though conservative, the Maryland Bridge did not enjoy a high reputation because of the high rate of debonding (falling off).
In the last several decades, the use of zirconia as a restorative material in dentistry has dramatically risen due to its toughness, resemblance in color to natural teeth, and affordability. Also, composite resin bonding agents (adhesive for dental fillings) have increased in strength and effectiveness. With these two advancements, the possibility of overcoming the some of the previous shortcomings with the Maryland Bridge is more of a reality.
The type of zirconia-wing bridge we are researching in this study has two wings which generally have three countersunk holes (meaning that the circumference of the outer portion of the hole is larger than the inner part of the hole). Composite resin (dental filling material) is placed in the holes as well as under and around the wings.
In summary, the zirconia-wing bridge presents a desirable alternative to traditional options for missing anterior teeth. With the advancements in resin-bonding and zirconia, this study seeks to examine how these combined elements can be used in the zirconia-wing bridge to maximize durability and retention in clinical scenarios.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Utah
-
South Jordan, Utah, United States, 84095
- Roseman University of Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Registered patient at Roseman University of Health Sciences in South Jordan, Utah who has undergone a health and dental screening
- One missing anterior tooth
- Adjacent teeth to the missing tooth must be non-restored or minimally-restored in with gums that have pockets of 4 millimeters or less
- Fluent in English or Spanish
Exclusion Criteria:
- Patients who are not registered at Roseman University of Health Sciences in South Jordan, Utah
- Patients who are unable to attend 6-month recall appointments
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with bridges still bonded to the teeth (retention)
Time Frame: 2 years observation
|
Determines how long the bridge stays bonded to the patient's teeth
|
2 years observation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with bridges that have no fractures (durability)
Time Frame: 2 years observation
|
Determine if there is any fracturing of the zirconia
|
2 years observation
|
Collaborators and Investigators
Investigators
- Principal Investigator: David G McMillan, DDS, Roseman University of Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1164902
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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