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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01369108
First Posted: June 8, 2011
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
3M
  Purpose

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.


Condition Intervention
Dental Caries Device: Flowable composite Device: Conventional composite restorative

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of a Low Shrinkage Flowable Resin Composite in Adult Teeth

Resource links provided by NLM:


Further study details as provided by 3M:

Primary Outcome Measures:
  • Clinical performance [ Time Frame: 24 months ]
    Efficiency of flowable composite in clinical service in restoration of small Class I lesions over a 24 month time frame


Enrollment: 60
Study Start Date: January 2011
Study Completion Date: December 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Flowable composite
Flowable composite
Device: Flowable composite
Restoration of small Class V and I cavities in molar and premolar teeth
Other Name: Filtek Supreme Ultra Flowable Restorative 3M ESPE)
Active Comparator: Conventional composite
Highly filled conventional composite restorative
Device: Conventional composite restorative
Restoration of small Class V and I cavities in molar and premolar teeth

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 TMJ related therapy
  • is pregnant at time of screening or tooth restoration
  • has known sensitivity to acrylates or related materials
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01369108


Locations
United States, Alabama
University of Alabama at Birmingham School of Dentistry, 605 School of Dentistry Building, 1919 7th Avenue South
Birmingam, Alabama, United States, 35233-2005
Sponsors and Collaborators
3M
Investigators
Principal Investigator: John O Burgess, DDS, MS Unversity of Alabama at Birmingam Dental School
  More Information

Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT01369108     History of Changes
Other Study ID Numbers: CR-10-013
First Submitted: June 7, 2011
First Posted: June 8, 2011
Last Update Posted: October 12, 2017
Last Verified: July 2013

Keywords provided by 3M:
small Class I
molar and premolar
low stress flowable composite
adult
Restoration
small caries lesions

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases