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

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ClinicalTrials.gov Identifier: NCT01369108
Recruitment Status : Completed
First Posted : June 8, 2011
Results First Posted : November 9, 2017
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
3M

Brief Summary:

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 or disease Intervention/treatment Phase
Dental Caries Device: Flowable composite Device: Conventional composite restorative Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Study Start Date : January 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Clinical Performance by Cvar & Ryge Scores [ Time Frame: baseline, 6, 12 and 24 months ]

    Clinical performance reported on 6 parameters as the % of teeth with perfect scores ("A" rating).

    Cvar & Ryge scores measure 6 parameters: Anatomic form (rated A,B= satisfactory, C=unsatisfactory); Color Match (A=match, B=mismatch, but within normal, C=mismatch outside normal); Marginal Adaptation (A=no visible crevice, B=no exposure of dentin, C=defect to enamel-dentine junction, D= fracture, missing); Marginal Discoloration (A=none, B= marginal discoloration, C=marginal discoloration to pulpal direction); Surface Integrity (A=smooth, B=slight rough, C=Pitted, D=fracture)'Secondary caries (A=none, D=present).


  2. Clinical Performance by VAS (Pain Scale) [ Time Frame: baseline, 6, 12 and 24 months ]
    Sensitivity to cold was measured by applying a cotton pellet soaked with pulp vitality refrigerant spray (Endo Ice, Coltene/ Whaledent, Cuyahoga Falls, OH, USA) to the tooth for three seconds. Sensitivity to biting was measured by having the patient bite on a cotton roll for five seconds. After each test, the subject was asked to place an ''X'' on a 10-mm line labeled ''1'' on the left and ''10'' on the right. Patients were told that a ''10'' represents the worst pain they can imagine (ie, childbirth, major surgery, or kidney stone) and that ''1'' represents no sensation at all.



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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 Temporomandibular Joint (TMJ) related therapy
  • is pregnant at time of screening or tooth restoration
  • has known sensitivity to acrylates or related materials

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
Birmingham, Alabama, United States, 35233-2005
Sponsors and Collaborators
3M
Investigators
Principal Investigator: John O Burgess, DDS, MS Unversity of Alabama at Birmingam Dental School

Publications of Results:
Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT01369108     History of Changes
Other Study ID Numbers: CR-10-013
First Posted: June 8, 2011    Key Record Dates
Results First Posted: November 9, 2017
Last Update Posted: November 9, 2017
Last Verified: November 2017

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