Clinical Study on a New Flowable Composite as a Restorative in Adult Teeth

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-12-31

Brief Summary

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Study hypothesis: a new, low polymerization stress flowable composite performs no differently to a conventional, highly filled composite filling material when used as a restorative in small cavities in back teeth.

Study will evaluate the clinical performance of a low shrinking flowable composite filling material, compared with a conventional, highly filled composite restorative when used to permanently fill small cavities in molar and premolar teeth in adult patients.

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Detailed Description

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The study will evaluate clinical performance of a low shrink flowable composite filling material and compare it with a conventional, highly filled composite. The study materials will be used to restore small cavities in molar and premolar teeth in adult patients.

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Flowable composite

Group Type EXPERIMENTAL

Flowable composite

Intervention Type DEVICE

Restoration of small Class V and I cavities in molar and premolar teeth

Conventional composite

Highly filled conventional composite restorative

Group Type ACTIVE_COMPARATOR

Conventional composite restorative

Intervention Type DEVICE

Restoration of small Class V and I cavities in molar and premolar teeth

Interventions

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Flowable composite

Restoration of small Class V and I cavities in molar and premolar teeth

Intervention Type DEVICE

Conventional composite restorative

Restoration of small Class V and I cavities in molar and premolar teeth

Intervention Type DEVICE

Other Intervention Names

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Filtek Supreme Ultra Flowable Restorative 3M ESPE)

Eligibility Criteria

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Inclusion Criteria

* 19 years or older
* must give written consent
* be in good general health
* be available for required follow-up visits
* have at least 28 teeth

Exclusion Criteria

* has rampant, uncontrolled caries
* has advanced, untreated periodontal disease
* heavy use of smoking tobacco (2 packs or equivalent a day)or chewing tobacco
* has systemic or local disorders that contra-indicate the dental procedures needed in this study
* has evidence of xerostomia
* has evidence of severe bruxing or clenching, or in need of Temporomandibular Joint (TMJ) related therapy
* is pregnant at time of screening or tooth restoration
* has known sensitivity to acrylates or related materials

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No