Trial Outcomes & Findings for Reducing Bacteria That Cause Tooth Decay (NCT NCT03062605)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

48 participants

Primary outcome timeframe

Baseline, 12 weeks

Results posted on

2019-12-24

Participant Flow

Participant milestones

Participant milestones
Measure	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	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)
Overall Study STARTED	25	23
Overall Study COMPLETED	14	13
Overall Study NOT COMPLETED	11	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age of one female in Treatment arm and one male in Control arm were unknown

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment(TX) n=25 Participants 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	Control (CT) n=23 Participants 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)	Total n=48 Participants Total of all reporting groups
Age, Continuous	40.4 years STANDARD_DEVIATION 10.2 • n=24 Participants • Age of one female in Treatment arm and one male in Control arm were unknown	38.2 years STANDARD_DEVIATION 6.6 • n=22 Participants • Age of one female in Treatment arm and one male in Control arm were unknown	39.4 years STANDARD_DEVIATION 8.6 • n=46 Participants • Age of one female in Treatment arm and one male in Control arm were unknown
Sex: Female, Male Female	15 Participants n=25 Participants	18 Participants n=23 Participants	33 Participants n=48 Participants
Sex: Female, Male Male	10 Participants n=25 Participants	5 Participants n=23 Participants	15 Participants n=48 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	25 participants n=25 Participants	23 participants n=23 Participants	48 participants n=48 Participants

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Population: Number analyzed includes participants retained in the study for whom CRT results were available

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.

Outcome measures

Outcome measures
Measure	Treatment(TX) n=25 Participants 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	Control (CT) n=23 Participants 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)
Microbial Levels Strep Mutans >10^5 at Baseline	11 Participants	7 Participants
Microbial Levels Lactobacillus >10^5 at Baseline	15 Participants	15 Participants
Microbial Levels Strep Mutans >10^5 at 12 Weeks	2 Participants	5 Participants
Microbial Levels Lactobacillus >10^5 at 12 Weeks	5 Participants	4 Participants

Adverse Events

Treatment(TX)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control (CT)

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

Dr. Vladimir W. Spolsky

UCLA

Phone: 310-794-0700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place