N/A
N=102
Cold Plasma for Dental Restoration and Caries Prevention
Dental Restoration · Caries
Bottom Line
View on ClinicalTrials.gov: NCT01529606 ↗Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Number of Decayed, Missing and Filling Teeth (DMFT) — 6.29; 5.14 teeth
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Composite restoration and tooth cleaning (Other); Plasma treatment (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Nanova, Inc
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Decayed, Missing and Filling Teeth (DMFT) |
6.29; 5.14 | — |
| PRIMARY Decayed and Filling Surfaces |
9.03; 7.72 | — |
| PRIMARY Restoration Failure Rate |
2; 0 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01529606). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.