NCT04378140

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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
56mo left

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress66%
May 2017Dec 2030

Study Start

First participant enrolled

May 5, 2017

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2030

Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

13.6 years

First QC Date

May 4, 2020

Last Update Submit

April 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of participants with bridges that have no fractures (durability)

    2 years observation

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roseman University of Health Sciences

South Jordan, Utah, 84095, United States

Location

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • David G McMillan, DDS

    Roseman University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 4, 2020

First Posted

May 7, 2020

Study Start

May 5, 2017

Primary Completion (Estimated)

December 20, 2030

Study Completion (Estimated)

December 20, 2030

Last Updated

April 11, 2024

Record last verified: 2024-04

Locations