Cold Plasma for Dental Restoration and Caries Prevention

NCT ID: NCT01529606

Last Updated: 2020-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-06-30

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.

Conditions

Dental Restoration; Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Composite restoration and tooth cleaning

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Plasma treatment

Intervention Type: PROCEDURE

plasma treatment after preparation and for caries prevention

Interventions

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.

Intervention Type: OTHER

Plasma treatment

plasma treatment after preparation and for caries prevention

Intervention Type: PROCEDURE

Other Intervention Names

Standard composite filling and preventive treatment; Plasma treatment and standard preventive treatment

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: collaborator

Nanova, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Liang Hong

Associate Professor and Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liang Hong, DDS, Ph.D

Role: PRINCIPAL_INVESTIGATOR

The University of Tennessee Health Science Center

Locations

University of Tennessee Health Science

Memphis, Tennessee, United States

Countries

United States

Other Identifiers

5R44DE019041

Identifier Type: NIH

Identifier Source: secondary_id

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5R44DE019041

Identifier Type: NIH

Identifier Source: org_study_id

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