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Cold Plasma for Dental Restoration and Caries Prevention

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.
 
ClinicalTrials.gov Identifier: NCT01529606
Recruitment Status : Completed
First Posted : February 9, 2012
Results First Posted : April 16, 2020
Last Update Posted : April 16, 2020
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Liang Hong, University of Tennessee

Tracking Information
First Submitted Date  ICMJE February 3, 2012
First Posted Date  ICMJE February 9, 2012
Results First Submitted Date  ICMJE February 28, 2020
Results First Posted Date  ICMJE April 16, 2020
Last Update Posted Date April 16, 2020
Study Start Date  ICMJE September 2012
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2020)
  • Number of Decayed, Missing and Filling Teeth (DMFT) [ Time Frame: 12 months ]
    Number of decayed, missing and filling teeth (DMFT) during 12 months
  • Decayed and Filling Surfaces [ Time Frame: 12 months ]
    Number of decayed and filling surfaces
  • Restoration Failure Rate [ Time Frame: 12 months ]
    Composite restoration evaluation for fracture or loss of filling partially or completely, with or without recurrent caries.
Original Primary Outcome Measures  ICMJE
 (submitted: February 8, 2012)
caries development [ Time Frame: 18 months ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2012)
restoration failure rate [ Time Frame: 18 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cold Plasma for Dental Restoration and Caries Prevention
Official Title  ICMJE Development of a Miniature Plasma Brush for Dental Clinical Applications
Brief Summary The main objective of this entire research project is to develop a miniature atmospheric cold plasma brush (m-ACPB) for dental clinical applications. The objective of the clinical trial portion of the study is to compare the longevity and durability of dental composite restorations created using the plasma brush, to that of the standard care in dentistry for treating dental cavities, and effects on caries prevention.
Detailed Description The study will be a randomized controlled trial (RCT) and be approved by the institute review board of the University of Tennessee Health Science Center. The study subjects will be composed of young adults 18-35 years old in order to control effects of age on caries. Also the subjects must be Caucasian or Africa American. Young adult patients will be recruited from the UTHSC dental clinics.The baseline visit include a dental exam by one of the investigators, standard preventive dental care (e.g cleaning, application of fluoride varnish), anthropometric measurements, oral health interview survey. 100 patients who meet all inclusion and exclusion criteria will be recruited after they sign an informed consent form. These patients will be randomly assigned to 1 of 2 study groups. Randomization assignment will be stratified by age and number of teeth with caries. Two study groups will be: 1.) plasma treatment group and 2) standard treatment group. For patients in standard treatment group, they will receive composite resin restoration for all decayed teeth and standard preventive treatment (cleaning and fluoride varnish application) at baseline. For patients in plasma treatment group, they will receive plasma treatment after cavity preparation, composite resin restoration, standard preventive treatment followed by plasma treatment for non-carious teeth. Standard preventive treatment and plasma treatment will be repeated on semi-annual (6-month) recall visits. All composite restorations will be placed according to the manufacturer's instruction. Only one composite commercially available will be used during the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Dental Restoration
  • Caries
Intervention  ICMJE
  • Other: Composite restoration and tooth cleaning
    Standard preventive treatment will be repeated on semi-annual (6-month) recall visits. All composite restorations will be placed according to the manufacturer's instruction.
    Other Name: Standard composite filling and preventive treatment
  • Procedure: Plasma treatment
    plasma treatment after preparation and for caries prevention
    Other Name: Plasma treatment and standard preventive treatment
Study Arms  ICMJE
  • Active Comparator: Standard care
    Fifty patients will be recruited into standard treatment group and they will receive composite resin restoration for all decayed teeth and standard preventive treatment (cleaning and fluoride varnish application) at baseline.
    Intervention: Other: Composite restoration and tooth cleaning
  • Experimental: Plasma treatment
    Fifty patients will be recruited into plasma treatment group and they will receive plasma treatment after cavity preparation, composite resin restoration, standard preventive treatment followed by plasma treatment for non-carious teeth.
    Intervention: Procedure: Plasma treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 23, 2014)
102
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2012)
100
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • subject must be Caucasian or Africa American, 18-35 years old, have written, completed, informed consent forms;
  • be generally healthy;
  • be able to participate in the study;
  • have no diagnosed periodontitis and pericoronitis;
  • have no active mucosal diseases such as aphthous ulcers and herpetic stomatitis.

They must also agree to follow study instructions.

The patients must meet the following specific entry criteria:

  • 1-5 untreated caries and at least one class II caries.

Exclusion Criteria:

  • each subject must have no diagnosed diabetes mellitus or any other endocrine diseases;
  • no diagnosed cardiovascular diseases;
  • no diagnosed immune-compromised diseases, such as HIV and AIDS;
  • no other serious systemic diseases, such as cancer;
  • no antibiotic therapy in the past 6 months;
  • no use of non-steroidal anti-inflammatory drugs (NSAIDS) in the past 3 months; and
  • no reported use of illicit drugs.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01529606
Other Study ID Numbers  ICMJE 5R44DE019041( U.S. NIH Grant/Contract )
5R44DE019041 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Liang Hong, University of Tennessee
Study Sponsor  ICMJE Nanova, Inc
Collaborators  ICMJE National Institute of Dental and Craniofacial Research (NIDCR)
Investigators  ICMJE
Principal Investigator: Liang Hong, DDS, Ph.D The University of Tennessee Health Science Center
PRS Account Nanova, Inc
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP