Cold Plasma for Dental Restoration and Caries Prevention

April 6, 2020 updated by: Liang Hong, Nanova, Inc

Development of a Miniature Plasma Brush for Dental Clinical Applications

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • University of Tennessee Health Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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 Names:
  • Standard composite filling and preventive treatment
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.
Procedure: Plasma treatment
plasma treatment after preparation and for caries prevention
Other Names:
  • Plasma treatment and standard preventive treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Decayed, Missing and Filling Teeth (DMFT)
Time Frame: 12 months
Number of decayed, missing and filling teeth (DMFT) during 12 months
12 months
Decayed and Filling Surfaces
Time Frame: 12 months
Number of decayed and filling surfaces
12 months
Restoration Failure Rate
Time Frame: 12 months
Composite restoration evaluation for fracture or loss of filling partially or completely, with or without recurrent caries.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanova, Inc

Collaborators

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

  • Principal Investigator: Liang Hong, DDS, Ph.D, The University of Tennessee Health Science Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

February 3, 2012

First Submitted That Met QC Criteria

February 8, 2012

First Posted (Estimate)

February 9, 2012

Study Record Updates

Last Update Posted (Actual)

April 16, 2020

Last Update Submitted That Met QC Criteria

April 6, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 5R44DE019041 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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