Clinical trial NCT01529606: Cold Plasma for Dental Restoration and Caries Prevention
Official title: Development of a Miniature Plasma Brush for Dental Clinical Applications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Restoration
Caries
Keywords: dental restoration
dental caries
tooth cavity
Lead sponsor: Nanova, Inc
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2012-02-09
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Decayed, Missing and Filling Teeth (DMFT)
timeFrame: 12 months
measure: Decayed and Filling Surfaces
timeFrame: 12 months
measure: Restoration Failure Rate
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: University of Tennessee Health Science
state: Tennessee
Study officials:
affiliation: The University of Tennessee Health Science Center
name: Liang Hong, DDS, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: