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Completed

NCT Number: NCT01529606

Cold Plasma for Dental Restoration and Caries Prevention

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Tennessee Health Science

Memphis, Tennessee, 38163, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Composite restoration and tooth cleaning

Other

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

Plasma treatment

Procedure

plasma treatment after preparation and for caries prevention

Other names: Plasma treatment and standard preventive treatment

Primary outcomes

  1. Number of Decayed, Missing and Filling Teeth (DMFT)

    Time frame: 12 months

    Number of decayed, missing and filling teeth (DMFT) during 12 months

  2. Decayed and Filling Surfaces

    Time frame: 12 months

    Number of decayed and filling surfaces

  3. Restoration Failure Rate

    Time frame: 12 months

    Composite restoration evaluation for fracture or loss of filling partially or completely, with or without recurrent caries.

Sponsors and collaborators

Lead sponsor

Nanova, Inc

Industry

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study title

Development of a Miniature Plasma Brush for Dental Clinical Applications

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 9, 2012
Registry last updated
Apr 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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