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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04378140
Other study ID # 1164902
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 5, 2017
Est. completion date December 20, 2030

Study information

Verified date April 2024
Source Roseman University of Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 8
Est. completion date December 20, 2030
Est. primary completion date December 20, 2030
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
zirconia wing bridge
The zirconia wing bridge consists of an artificial tooth made out of zirconia and porcelain on the front side with two zirconia wings that are bonded (glued) onto the back of the two adjacent teeth in the patient's mouth.

Locations

Country Name City State
United States Roseman University of Health Sciences South Jordan Utah

Sponsors (1)

Lead Sponsor Collaborator
Roseman University of Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with bridges still bonded to the teeth (retention) Determines how long the bridge stays bonded to the patient's teeth 2 years observation
Secondary Number of participants with bridges that have no fractures (durability) Determine if there is any fracturing of the zirconia 2 years observation
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