Caries, Dental Restoration
Conditions
Keywords
dental restoration, dental caries, tooth cavity
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.
Interventions
OTHERComposite 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.
PROCEDUREPlasma treatment
plasma treatment after preparation and for caries prevention
Sponsors
National Institute of Dental and Craniofacial Research (NIDCR)
Nanova, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Decayed, Missing and Filling Teeth (DMFT) | 12 months | Number of decayed, missing and filling teeth (DMFT) during 12 months |
| Decayed and Filling Surfaces | 12 months | Number of decayed and filling surfaces |
| Restoration Failure Rate | 12 months | Composite restoration evaluation for fracture or loss of filling partially or completely, with or without recurrent caries. |
Countries
United States
Participant flow
Recruitment details
Two more patients were recruited because patients received recruitment information and requested participation in the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 55 |
| 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 | 47 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 21 | 18 |
Baseline characteristics
| Characteristic | Standard Care | Plasma Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 55 Participants | 47 Participants | 102 Participants |
| Age, Continuous | 27.9 years STANDARD_DEVIATION 4.4 | 27.7 years STANDARD_DEVIATION 4.6 | 27.8 years STANDARD_DEVIATION 4.6 |
| Education level 4 year college | 8 Participants | 12 Participants | 20 Participants |
| Education level Graduate or professional school | 19 Participants | 16 Participants | 35 Participants |
| Education level High school or below | 10 Participants | 8 Participants | 18 Participants |
| Education level Some college | 18 Participants | 11 Participants | 29 Participants |
| Health Insurance No | 13 Participants | 17 Participants | 30 Participants |
| Health Insurance Yes | 42 Participants | 30 Participants | 72 Participants |
| Income level <$20,000 | 23 Participants | 22 Participants | 45 Participants |
| Income level $20,000-$39,999 | 21 Participants | 19 Participants | 40 Participants |
| Income level $40,000-$59,999 | 2 Participants | 5 Participants | 7 Participants |
| Income level $60,000 or more | 9 Participants | 1 Participants | 10 Participants |
| Number of decayed and filling surfaces (DMFS) | 8.27 tooth surface STANDARD_DEVIATION 8.28 | 6.89 tooth surface STANDARD_DEVIATION 7.5 | 7.58 tooth surface STANDARD_DEVIATION 7.76 |
| Number of decayed, missing and filling teeth | 6.09 tooth STANDARD_DEVIATION 4.22 | 5.00 tooth STANDARD_DEVIATION 4.55 | 5.54 tooth STANDARD_DEVIATION 4.38 |
| Number of decayed surfaces (DS) | 2.06 tooth surface STANDARD_DEVIATION 6.57 | 0.66 tooth surface STANDARD_DEVIATION 1.73 | 1.57 tooth surface STANDARD_DEVIATION 3.48 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 39 Participants | 27 Participants | 66 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 20 Participants | 36 Participants |
| Region of Enrollment United States | 55 participants | 47 participants | 102 participants |
| Sex: Female, Male Female | 35 Participants | 32 Participants | 67 Participants |
| Sex: Female, Male Male | 20 Participants | 15 Participants | 35 Participants |
| Tooth brushing >=3 times per day | 8 Participants | 5 Participants | 13 Participants |
| Tooth brushing Once per day | 13 Participants | 10 Participants | 23 Participants |
| Tooth brushing <one time per day | 3 Participants | 0 Participants | 3 Participants |
| Tooth brushing Twice per day | 31 Participants | 32 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 47 |
| other Total, other adverse events | 0 / 55 | 0 / 47 |
| serious Total, serious adverse events | 0 / 55 | 0 / 47 |
Outcome results
Primary
Decayed and Filling Surfaces
Number of decayed and filling surfaces
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Decayed and Filling Surfaces | 9.03 tooth surface | Standard Deviation 8.14 |
| Plasma Treatment | Decayed and Filling Surfaces | 7.72 tooth surface | Standard Deviation 8.16 |
Primary
Number of Decayed, Missing and Filling Teeth (DMFT)
Number of decayed, missing and filling teeth (DMFT) during 12 months
Time frame: 12 months
Population: 34 participants in standard care group and 29 in plasma group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Number of Decayed, Missing and Filling Teeth (DMFT) | 6.29 teeth | Standard Deviation 4.07 |
| Plasma Treatment | Number of Decayed, Missing and Filling Teeth (DMFT) | 5.14 teeth | Standard Deviation 4.7 |
Primary
Restoration Failure Rate
Composite restoration evaluation for fracture or loss of filling partially or completely, with or without recurrent caries.
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Care | Restoration Failure Rate | 2 composite fillings |
| Plasma Treatment | Restoration Failure Rate | 0 composite fillings |