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Clinical Investigation of a New Bulk Fill Composite Resin in the Restoration of Posterior Teeth

NCT ID: NCT02572570

Last Updated: 2020-12-19

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2019-12-05

Brief Summary

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Polymerization shrinkage remains one of the primary disadvantages of composite resin restorative materials (tooth-colored fillings). To minimize the effects of polymerization shrinkage in the restorative treatment, the 3M ESPE company has developed a composite resin called Filtek Bulk Fill Posterior Restorative. Its decreased polymerization shrinkage and properties allow the material to be inserted in one single increment, expediting treatment. This clinical trial is designed to evaluate the performance of the new bulk fill composite resin in Class II (two-surface posterior) fillings.

Detailed Description

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Conditions

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Dental Restoration Failure of Marginal Integrity Dental Caries Unrepairable Overhanging of Dental Restorative Materials Poor Aesthetics of Existing Restoration Secondary Dental Caries Associated With Failed or Defective Dental Restorations Fractured Dental Restorative Materials Without Loss of Materials Fracture of Dental Restorative Materials With Loss of Material

Keywords

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Adult dental care

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Posterior Composite Resin Restoration

Participants will receive two commercially available tooth-colored restorative materials used for direct restoration as per manufacturer's instructions.

Group Type EXPERIMENTAL

Filtek Bulk Fill Posterior

Intervention Type DEVICE

Tooth (teeth) affected by dental caries or with an existing defective filling restored using the materials listed (Filtek Bulk Fill Posterior). Procedures done using local anesthesia and following ordinary restorative techniques.

Filtek Supreme Ultra

Intervention Type DEVICE

Tooth (teeth) affected by dental caries or with an existing defective filling restored using the materials listed (Filtek Supreme Ultra). Procedures done using local anesthesia and following ordinary restorative techniques.

Interventions

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Filtek Bulk Fill Posterior

Tooth (teeth) affected by dental caries or with an existing defective filling restored using the materials listed (Filtek Bulk Fill Posterior). Procedures done using local anesthesia and following ordinary restorative techniques.

Intervention Type DEVICE

Filtek Supreme Ultra

Tooth (teeth) affected by dental caries or with an existing defective filling restored using the materials listed (Filtek Supreme Ultra). Procedures done using local anesthesia and following ordinary restorative techniques.

Intervention Type DEVICE

Other Intervention Names

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Dental filling Dental filling

Eligibility Criteria

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Inclusion Criteria

* Be 18 years of age and older
* Have a pair of similar cavities or failed dental fillings in vital permanent posterior teeth requiring treatment
* Be capable of giving written informed consent.

Exclusion Criteria

* Have a self-reported history of any adverse reaction to materials of the types to be evaluated
* Have a medical or dental history that could possibly complicate the provision of the proposed treatment and/or influence the behavior and performance of the treatment in clinical service.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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3M ESPE

INDUSTRY

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rick Walter, DDS

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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University of North Carolina at Chapel Hill School of Dentistry

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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14-3097

Identifier Type: -

Identifier Source: org_study_id