Caries, Dental, Cariostatic Agents
Conditions
Brief summary
The purpose of the study is to determine the effect of a two-step mouth rinsing procedure on reducing the germs (mutans Streptococci) that cause tooth decay. We hope that the two-step mouth rinse (0.3% NaOCl followed by 10% Povidone Iodine) decreases the tooth causing germs better than the one-step mouth rinse (10% Povidone Iodine). The mouth rinse for both treatment groups is done only once at the beginning of the study after the initial saliva samples are taken, and before a detailed examination of the teeth and gums. It is hypothesized that the treatment group receiving the NaOCl and Povidone iodine will have significantly lower microbial counts than the control group (Povidone iodine) because the NaOCl will disrupt the microbial biofilm and make the Povidone iodine more effective in decreasing the microbes in the biofilm. Microbial counts are made from Salivary samples taken from participants at baseline, one week, one month, two months and three months. The samples are tested by two commercial methods for determining microbial counts. The CariScreen Test is a rapid bioluminescence assay that quantitates the total number of all of the organisms present. The CRT test requires a culture media that is specific for the two germs (S. mutans and Lactobacillus) strongly associated with tooth decay. The results of the CRT Test are read after three days of incubation.
Interventions
DRUGIodine (Betadine)
BIOLOGICALNaOCL
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Masking description
This was a single blind study. The participants knew which one time treatment they were receiving, but the person doing the saliva sampling and testing did not know which treatment the participant was assigned
Intervention model description
Participants were randomly assigned to one of two treatment groups and continued in parallel for the three-month duration of the study.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* being over 20 years of age; * having at least one obviously cavitated tooth; * refraining from smoking, brushing the teeth and using a mouthwash the day of the bacterial sampling; * refraining from using a commercial mouth rinse during the three months of the study; * having any two of the following risk factors in the Caries Management by Risk Assessment (CAMBRA) protocol which qualifies as a high caries risk. The high caries risk factors included: * receiving fillings within the past three years; * snacking frequently between meals; * presenting with hyposalivation due to medication, radiation or systemic conditions; * visual presence of heavy plaque accumulation; * and a minimum of 20 natural teeth.
Exclusion criteria
* using a systemic antibiotic within the past three months; * currently receiving dental treatment or planning to receive treatment within the next three months (emergency treatment allowed); * being pregnant or nursing; * any thyroid disease or sensitivity to iodine; * the use of a commercially available mouth rinse the day of the screening examination; * smoking, brushing the teeth and using a mouth rinse the day of the bacterial sampling; * not being able to make morning examinations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbial Levels | Baseline, 12 weeks | The CRT® Bacteria (Ivoclar Vivadent) saliva sample test is done on culture media that is specific for S. mutans and Lactobacillus. After incubation for 3 days the colonies are compared to photographic standards. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment(TX) Participants were assigned randomly to one of two treatment groups and continued in parallel for the three-month duration of the study. The first treatment group (TX) rinsed with NaOCL (0.3%) for one minute followed by rinsing with iodine (10%) for one minute
Iodine (Betadine)
NaOCL | 25 |
| Control (CT) Participants were assigned randomly to one of two treatment groups and continued in parallel for the three-month duration of the study. The control group (CT) rinsed with iodine (10%) for minute.
Iodine (Betadine) | 23 |
| Total | 48 |
Baseline characteristics
| Characteristic | Control (CT) | Total | Treatment(TX) |
|---|---|---|---|
| Age, Continuous | 38.2 years STANDARD_DEVIATION 6.6 | 39.4 years STANDARD_DEVIATION 8.6 | 40.4 years STANDARD_DEVIATION 10.2 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 23 participants | 48 participants | 25 participants |
| Sex: Female, Male Female | 18 Participants | 33 Participants | 15 Participants |
| Sex: Female, Male Male | 5 Participants | 15 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 23 |
| serious Total, serious adverse events | 0 / 25 | 0 / 23 |
Outcome results
Primary
Microbial Levels
The CRT® Bacteria (Ivoclar Vivadent) saliva sample test is done on culture media that is specific for S. mutans and Lactobacillus. After incubation for 3 days the colonies are compared to photographic standards.
Time frame: Baseline, 12 weeks
Population: Number analyzed includes participants retained in the study for whom CRT results were available
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment(TX) | Microbial Levels | Strep Mutans >10^5 at Baseline | 11 Participants |
| Treatment(TX) | Microbial Levels | Lactobacillus >10^5 at Baseline | 15 Participants |
| Treatment(TX) | Microbial Levels | Strep Mutans >10^5 at 12 Weeks | 2 Participants |
| Treatment(TX) | Microbial Levels | Lactobacillus >10^5 at 12 Weeks | 5 Participants |
| Control (CT) | Microbial Levels | Lactobacillus >10^5 at 12 Weeks | 4 Participants |
| Control (CT) | Microbial Levels | Strep Mutans >10^5 at Baseline | 7 Participants |
| Control (CT) | Microbial Levels | Strep Mutans >10^5 at 12 Weeks | 5 Participants |
| Control (CT) | Microbial Levels | Lactobacillus >10^5 at Baseline | 15 Participants |
Comparison: Strep Mutans, Baseline-12 Weeksp-value: 0.35McNemar
Comparison: Strep Mutans, Baseline-12 Weeksp-value: 0.29McNemar
Comparison: Lactobacillus, Baseline-12 Weeksp-value: 0.09McNemar
Comparison: Lactobacillus, Baseline-12 Weeksp-value: 0.13McNemar