Cold Plasma for Dental Restoration and Caries Prevention

Study Overview
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Brief Summary
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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
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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.

Official Title
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Development of a Miniature Plasma Brush for Dental Clinical Applications

Conditions
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Dental Restoration, Caries

Intervention / Treatment
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* Other: Composite restoration and tooth cleaning
* Procedure: Plasma treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard care<br>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. | Other: Composite restoration and tooth cleaning<br>* 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.<br>* Other names: Standard composite filling and preventive treatment;|
| Experimental: Plasma treatment<br>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. | Procedure: Plasma treatment<br>* plasma treatment after preparation and for caries prevention<br>* Other names: Plasma treatment and standard preventive treatment;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental restoration, dental caries, tooth cavity