Clinical trial NCT04378140: Retention and Durability of the Anterior Zirconia Wing Bridge
Official title: Retention and Durability of the Anterior Zirconia Wing Bridge
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Missing Teeth
Partial-edentulism
Lead sponsor: Roseman University of Health Sciences
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of both genders, ages 18 and above with one missing anterior teeth that has periodontal pockets of no more than 4 mm with abutment teeth being non-restored or minimally restored.

Brief 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with bridges still bonded to the teeth (retention)
timeFrame: 2 years observation
Secondary outcomes:
measure: Number of participants with bridges that have no fractures (durability)
timeFrame: 2 years observation
Other outcomes:
Locations:
city: South Jordan
country: United States
facility: Roseman University of Health Sciences
state: Utah
Study officials:
affiliation: Roseman University of Health Sciences
name: David G McMillan, DDS
role: PRINCIPAL_INVESTIGATOR
References: