Cold Plasma for Dental Restoration and Caries Prevention

Caries Clinical Trial

Official title:

Development of a Miniature Plasma Brush for Dental Clinical Applications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01529606
• Other study ID #: 5R44DE019041
• Secondary ID: 5R44DE019041
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: June 2014

Study information

• Verified date: April 2020
• Source: Nanova, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caries
• Dental Restoration

Intervention

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.

Procedure:
• Plasma treatment
plasma treatment after preparation and for caries prevention

Locations

Country	Name	City	State
United States	University of Tennessee Health Science	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Nanova, Inc	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

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