Cold Plasma for Dental Restoration and Caries Prevention

Nanova

Status: Completed

Conditions: Dental Restoration; Caries

Treatments: Procedure: Plasma treatment; Other: Composite restoration and tooth cleaning

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT01529606

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

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

102 participants in 2 patient groups

Standard care

Active Comparator group

Description:

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.

Treatment:

Other: Composite restoration and tooth cleaning

Plasma treatment

Experimental group

Description:

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.

Treatment:

Procedure: Plasma treatment