Cold Plasma for Dental Restoration and Caries Prevention
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Dental Restoration Caries |
Other: Composite restoration and tooth cleaning Procedure: Plasma treatment |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Development of a Miniature Plasma Brush for Dental Clinical Applications |
- caries development [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- restoration failure rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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.
|
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.
Other Name: Standard composite filling and preventive treatment
|
|
Experimental: 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.
|
Procedure: Plasma treatment
plasma treatment after preparation and for caries prevention
Other Name: Plasma treatment and standard preventive treatment
|
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| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Contact: Liang Hong | 901-457-2369 | lhong2@uthsc.edu |
| United States, Tennessee | |
| University of Tennessee Health Science | Not yet recruiting |
| Memphis, Tennessee, United States, 38163 | |
| Contact: Liang Hong 901-448-2369 lhong2@uthsc.edu | |
| Principal Investigator: | Liang Hong, DDS, Ph.D | The University of Tennessee Health Science Center |
More Information
No publications provided
| Responsible Party: | Liang Hong, Associate Professor and Director, University of Tennessee |
| ClinicalTrials.gov Identifier: | NCT01529606 History of Changes |
| Other Study ID Numbers: | 5R44DE019041, 5R44DE019041 |
| Study First Received: | February 3, 2012 |
| Last Updated: | February 8, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by Nanova, Inc:
|
dental restoration dental caries tooth cavity |
Additional relevant MeSH terms:
|
Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013