Back to resultsClinical Study on a New Flowable Composite as a Restorative in Adult Teeth
Primary Purpose
Dental Caries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Flowable composite
Conventional composite restorative
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries focused on measuring small Class I, molar and premolar, low stress flowable composite, adult, Restoration, small caries lesions
Eligibility 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
Sites / Locations
- University of Alabama at Birmingham School of Dentistry, 605 School of Dentistry Building, 1919 7th Avenue South
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Flowable composite
Conventional composite
Arm Description
Flowable composite
Highly filled conventional composite restorative
Outcomes
Primary Outcome Measures
Clinical Performance by Cvar & Ryge Scores
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).
Clinical Performance by VAS (Pain Scale)
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01369108
Brief Title
Clinical Study on a New Flowable Composite as a Restorative in Adult Teeth
Official Title
Clinical Evaluation of a Low Shrinkage Flowable Resin Composite in Adult Teeth
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3M
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
small Class I, molar and premolar, low stress flowable composite, adult, Restoration, small caries lesions
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Flowable composite
Arm Type
Experimental
Arm Description
Flowable composite
Arm Title
Conventional composite
Arm Type
Active Comparator
Arm Description
Highly filled conventional composite restorative
Intervention Type
Device
Intervention Name(s)
Flowable composite
Other Intervention Name(s)
Filtek Supreme Ultra Flowable Restorative 3M ESPE)
Intervention Description
Restoration of small Class V and I cavities in molar and premolar teeth
Intervention Type
Device
Intervention Name(s)
Conventional composite restorative
Intervention Description
Restoration of small Class V and I cavities in molar and premolar teeth
Primary Outcome Measure Information:
Title
Clinical Performance by Cvar & Ryge Scores
Description
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).
Time Frame
baseline, 6, 12 and 24 months
Title
Clinical Performance by VAS (Pain Scale)
Description
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.
Time Frame
baseline, 6, 12 and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John O Burgess, DDS, MS
Organizational Affiliation
Unversity of Alabama at Birmingam Dental School
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham School of Dentistry, 605 School of Dentistry Building, 1919 7th Avenue South
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233-2005
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26237643
Citation
Lawson NC, Radhakrishnan R, Givan DA, Ramp LC, Burgess JO. Two-year Randomized, Controlled Clinical Trial of a Flowable and Conventional Composite in Class I Restorations. Oper Dent. 2015 Nov-Dec;40(6):594-602. doi: 10.2341/15-038-C. Epub 2015 Aug 3.
Results Reference
result
Learn more about this trial
Clinical Study on a New Flowable Composite as a Restorative in Adult Teeth
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