Trial Outcomes & Findings for Cold Plasma for Dental Restoration and Caries Prevention (NCT NCT01529606)
NCT ID: NCT01529606
Last Updated: 2020-04-16
Results Overview
Number of decayed, missing and filling teeth (DMFT) during 12 months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
102 participants
Primary outcome timeframe
12 months
Results posted on
2020-04-16
Participant Flow
Two more patients were recruited because patients received recruitment information and requested participation in the study.
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
47
|
|
Overall Study
COMPLETED
|
34
|
29
|
|
Overall Study
NOT COMPLETED
|
21
|
18
|
Reasons for withdrawal
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
21
|
18
|
Baseline Characteristics
Cold Plasma for Dental Restoration and Caries Prevention
Baseline characteristics by cohort
| Measure |
Standard Care
n=55 Participants
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.
|
Plasma Treatment
n=47 Participants
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
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
55 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
27.9 years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
27.7 years
STANDARD_DEVIATION 4.6 • n=7 Participants
|
27.8 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
39 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
47 participants
n=7 Participants
|
102 participants
n=5 Participants
|
|
Education level
High school or below
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Education level
Some college
|
18 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Education level
4 year college
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Education level
Graduate or professional school
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Income level
<$20,000
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Income level
$20,000-$39,999
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Income level
$40,000-$59,999
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Income level
$60,000 or more
|
9 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Health Insurance
Yes
|
42 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Health Insurance
No
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Tooth brushing
>=3 times per day
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Tooth brushing
Twice per day
|
31 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Tooth brushing
Once per day
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Tooth brushing
<one time per day
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Number of decayed, missing and filling teeth
|
6.09 tooth
STANDARD_DEVIATION 4.22 • n=5 Participants
|
5.00 tooth
STANDARD_DEVIATION 4.55 • n=7 Participants
|
5.54 tooth
STANDARD_DEVIATION 4.38 • n=5 Participants
|
|
Number of decayed and filling surfaces (DMFS)
|
8.27 tooth surface
STANDARD_DEVIATION 8.28 • n=5 Participants
|
6.89 tooth surface
STANDARD_DEVIATION 7.50 • n=7 Participants
|
7.58 tooth surface
STANDARD_DEVIATION 7.76 • n=5 Participants
|
|
Number of decayed surfaces (DS)
|
2.06 tooth surface
STANDARD_DEVIATION 6.57 • n=5 Participants
|
0.66 tooth surface
STANDARD_DEVIATION 1.73 • n=7 Participants
|
1.57 tooth surface
STANDARD_DEVIATION 3.48 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 34 participants in standard care group and 29 in plasma group
Number of decayed, missing and filling teeth (DMFT) during 12 months
Outcome measures
| Measure |
Standard Care
n=34 Participants
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.
|
Plasma Treatment
n=29 Participants
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
|
|---|---|---|
|
Number of Decayed, Missing and Filling Teeth (DMFT)
|
6.29 teeth
Standard Deviation 4.07
|
5.14 teeth
Standard Deviation 4.70
|
PRIMARY outcome
Timeframe: 12 monthsNumber of decayed and filling surfaces
Outcome measures
| Measure |
Standard Care
n=34 Participants
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.
|
Plasma Treatment
n=29 Participants
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
|
|---|---|---|
|
Decayed and Filling Surfaces
|
9.03 tooth surface
Standard Deviation 8.14
|
7.72 tooth surface
Standard Deviation 8.16
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 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.
Composite restoration evaluation for fracture or loss of filling partially or completely, with or without recurrent caries.
Outcome measures
| Measure |
Standard Care
n=67 composite fillings
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.
|
Plasma Treatment
n=54 composite fillings
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
|
|---|---|---|
|
Restoration Failure Rate
|
2 composite fillings
|
0 composite fillings
|
Adverse Events
Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Plasma Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place