Lithium Disilicate (CAD/CAM) Fixed Partial Dentures (FPD) Clinical Study

NCT ID: NCT03036566

Last Updated: 2024-07-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2020-03-05

Brief Summary

This investigation will be a clinical trial to study the performance of a high strength ceramic material for bridges to replace missing teeth. The ceramic material has been approved by the FDA for patient treatment. A computer technique will be used to make the bridges. The bridges will be cemented using an adhesive resin cement (MultiLink Automix/Ivoclar). The bridges are planned be evaluated for clinical performance at 6 months, 1 year, 2 years, 3 years, and if funding permits, 4 years, and 5 years. The purpose of the study is to measure how well the high strength bridges function over an extended period of time.

Detailed Description

The study will be composed of 30 bridges placed in adult patients that have been identified as requiring replacement of a single tooth. All the bridges will be made from the same high strength ceramic material (emaxCAD/Ivoclar) using a computer to make the entire bridge. All the crowns will be cemented using the most current marketed version of the manufacturer's adhesive resin cement (MultiLink Automix/Ivoclar). At each recall appointment an evaluation of the bridge will be completed as well as clinical photographs, an intraoral digital scan, and impression of the bridge. The purpose of the study is to measure how well the high strength bridges function over an extended period of time.

Conditions

Missing Tooth

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bridge

Three unit high strength ceramic (lithium disilicate/emaxCAD by Ivoclar) bridges replacing a single tooth.

Group Type: EXPERIMENTAL

Lithium disilicate ceramic (Ivoclar)

Intervention Type: DEVICE

Three unit high strength ceramic bridges replacing a single tooth.

Interventions

Lithium disilicate ceramic (Ivoclar)

Three unit high strength ceramic bridges replacing a single tooth.

Intervention Type: DEVICE

Other Intervention Names

fixed partial denture

Eligibility Criteria

Inclusion Criteria

• missing one anterior or premolar tooth that is appropriate for replacement with a bridge. The second premolar tooth will be the most distal tooth acceptable as a pontic for inclusion in the study.
• healthy periodontal status for the adjacent abutment teeth with 1:1 crown:root ratio
• abutment teeth must be asymptomatic prior to treatment
• Endodontically treated teeth will be acceptable for abutments as long as nonmetallic cores can be placed to retain the FPD since the lithium disilicate will be bonded to the abutments.
• no more than one bridge will be placed per patient. If a patient presents with more than one missing teeth acceptable for the study, premolar teeth will be included prior to anterior teeth. Each bridge will be three units and include only one missing tooth.

Exclusion Criteria

• sensitive abutment teeth
• teeth with a history of direct or indirect pulp capping procedures
• patients with significant untreated dental disease to include periodontitis and caries
• pregnant or lactating women
• patients with allergies to any material in the study
• patients unable to return for recall appointments

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ivoclar Vivadent AG

INDUSTRY

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Dennis J. Fasbinder, DDS

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dennis J Fasbinder, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HUM00081086

Identifier Type: -

Identifier Source: org_study_id