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| ID | Type | Description | Link |
|---|---|---|---|
| 5R44DE019041 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care | Active Comparator | 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. |
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| Plasma treatment | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Composite restoration and tooth cleaning | 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. |
| 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 |
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Inclusion Criteria:
They must also agree to follow study instructions.
The patients must meet the following specific entry criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liang Hong, DDS, Ph.D | The University of Tennessee Health Science Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tennessee Health Science | Memphis | Tennessee | 38163 | United States |
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Two more patients were recruited because patients received recruitment information and requested participation in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. Plasma treatment: plasma treatment after preparation and for caries prevention |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Care | Fifty five patients were 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Decayed, Missing and Filling Teeth (DMFT) | Number of decayed, missing and filling teeth (DMFT) during 12 months | 34 participants in standard care group and 29 in plasma group | Posted | Mean | Standard Deviation | teeth | 12 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Care | Fifty five patients were 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. 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. |
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No limitation is reported
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor | UTHSC | 901-448-2369 | lhong2@uthsc.edu |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D000093522 | COVID-19 Serotherapy |
| ID | Term |
|---|---|
| D019264 | Adoptive Transfer |
| D007116 | Immunization, Passive |
| D007114 | Immunization |
| D007167 | Immunotherapy |
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| Plasma treatment | Procedure | plasma treatment after preparation and for caries prevention |
|
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| BG001 | Plasma Treatment | Forty seven patients were 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. Plasma treatment: plasma treatment after preparation and for caries prevention |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Education level | Count of Participants | Participants |
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| Income level | Count of Participants | Participants |
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| Health Insurance | Count of Participants | Participants |
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| Tooth brushing | Count of Participants | Participants |
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| Number of decayed, missing and filling teeth | Mean | Standard Deviation | tooth |
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| Number of decayed and filling surfaces (DMFS) | Mean | Standard Deviation | tooth surface |
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| Number of decayed surfaces (DS) | Mean | Standard Deviation | tooth surface |
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Forty seven patients were 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. Plasma treatment: plasma treatment after preparation and for caries prevention |
|
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| Primary | Decayed and Filling Surfaces | Number of decayed and filling surfaces | Posted | Mean | Standard Deviation | tooth surface | 12 months |
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| Primary | Restoration Failure Rate | Composite restoration evaluation for fracture or loss of filling partially or completely, with or without recurrent caries. | After 12 months, in standard care group, we had 27 participants remaining and lost 28 participants; in plasma treatment group, we had 21 participants remaining and lost 26 participants. Units of analysis for composite restoration failure is number of composite restorations in each group. A participant may have more than one composite restoration. | Posted | Number | composite fillings | 12 months | composite fillings | composite fillings |
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|
| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Plasma Treatment | Forty seven patients were 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. Plasma treatment: plasma treatment after preparation and for caries prevention | 0 | 47 | 0 | 47 | 0 | 47 |
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| D056747 |
| Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |