Trial Outcomes & Findings for Efficacy of an Antibacterial Toothpaste and Patients' Satisfaction (NCT NCT05569850)

Results Overview

Agar Mitis salivarius with tellurium and bacitracin (MSTB) will be used for S. mutans isolation. The 0.1 ml saliva sample will be diluted with 0.9 ml of sterile normal saline; next, decimal dilutions of saliva will be made up to 10-3. Each medium plate will be cultured from 0.1 ml of the previously diluted sample to 10-3; then, the sample will be uniformly spread on the agar plates. Finally, the plates will be sealed. They will be incubated for 48 hours at 37°C. The bacterial colonies will be observed under a stereo microscope and identified by morphology and color. The CFU will be multiplied by the number of times the sample was originally diluted and expressed as the number of colony forming units per millilitre (CFU/mL) of saliva.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

4 weeks

Results posted on

2025-04-29

Participant Flow

Participant milestones

Participant milestones
Measure	Recently Introduced Toothpaste Brushing twice a day with a recently introduced toothpaste. Brushing: Brushing the teeth 2x a day for 4 weeks.	Commercial Toothpaste Brushing twice a day with a commercially available toothpaste. Brushing: Brushing the teeth 2x a day for 4 weeks.
Overall Study STARTED	50	50
Overall Study COMPLETED	46	39
Overall Study NOT COMPLETED	4	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Recently Introduced Toothpaste n=50 Participants Brushing twice a day with a recently introduced toothpaste. Brushing: Brushing the teeth 2x a day for 4 weeks.	Commercial Toothpaste n=50 Participants Brushing twice a day with a commercially available toothpaste. Brushing: Brushing the teeth 2x a day for 4 weeks.	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=100 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=50 Participants	50 Participants n=50 Participants	100 Participants n=100 Participants
Age, Categorical >=65 years	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=100 Participants
Age, Continuous	25.7 years STANDARD_DEVIATION 0.3 • n=50 Participants	25.3 years STANDARD_DEVIATION 0.4 • n=50 Participants	25.5 years STANDARD_DEVIATION 0.35 • n=100 Participants
Sex: Female, Male Female	29 Participants n=50 Participants	26 Participants n=50 Participants	55 Participants n=100 Participants
Sex: Female, Male Male	21 Participants n=50 Participants	24 Participants n=50 Participants	45 Participants n=100 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Italy	46 participants n=46 Participants • There was a drop-out of patients.	39 participants n=39 Participants • There was a drop-out of patients.	85 participants n=85 Participants • There was a drop-out of patients.

PRIMARY outcome

Timeframe: 4 weeks

Agar Mitis salivarius with tellurium and bacitracin (MSTB) will be used for S. mutans isolation. The 0.1 ml saliva sample will be diluted with 0.9 ml of sterile normal saline; next, decimal dilutions of saliva will be made up to 10-3. Each medium plate will be cultured from 0.1 ml of the previously diluted sample to 10-3; then, the sample will be uniformly spread on the agar plates. Finally, the plates will be sealed. They will be incubated for 48 hours at 37°C. The bacterial colonies will be observed under a stereo microscope and identified by morphology and color. The CFU will be multiplied by the number of times the sample was originally diluted and expressed as the number of colony forming units per millilitre (CFU/mL) of saliva.

Outcome measures

Outcome measures
Measure	Recently Introduced Toothpaste n=46 Participants Brushing twice a day with a recently introduced toothpaste. Brushing: Brushing the teeth 2x a day for 4 weeks.	Commercial Toothpaste n=39 Participants Brushing twice a day with a commercially available toothpaste. Brushing: Brushing the teeth 2x a day for 4 weeks.
Bacterial Count of Streptococcus Mutans (S. Mutans)	4.261 log CFU/ml Standard Deviation 0.0867	4.277 log CFU/ml Standard Deviation 0.0931

SECONDARY outcome

Timeframe: 4 weeks

The plaque will be disclosed using a disclosing solution and recorded as follows: score 0 = absence of plaque; score 1 = separate flecks of plaque on the cervical margin; score 2 = a thin, continuous band of plaque \[up to 1 mm\] at the cervical margin of the tooth; score 3 = a band of plaque wider than 1 mm, but covering less than one-third of the tooth crown; score 4 = plaque covering at least one-third, but less than two-third of the crown of the tooth; score 5 = plaque covering 2/3-crown or more of the crown of the tooth.

Outcome measures

Outcome measures
Measure	Recently Introduced Toothpaste n=46 Participants Brushing twice a day with a recently introduced toothpaste. Brushing: Brushing the teeth 2x a day for 4 weeks.	Commercial Toothpaste n=39 Participants Brushing twice a day with a commercially available toothpaste. Brushing: Brushing the teeth 2x a day for 4 weeks.
Plaque Index	0.1 score on a scale Standard Deviation 0.05	0.17 score on a scale Standard Deviation 0.1

SECONDARY outcome

Timeframe: 4 weeks

A North Carolina periodontal probe (Hu-Friedy, Chicago, IL, USA) will be used for determine gingival index according to the following scale: score 0 = absence of inflammation; score 1 = mild inflammation-slightly slight change in color and little change in texture; score 2 = moderate inflammation-moderate glazing, redness, edema, and hypertrophy; score 3 = severe inflammation-marked redness and hypertrophy.

Outcome measures

Outcome measures
Measure	Recently Introduced Toothpaste n=46 Participants Brushing twice a day with a recently introduced toothpaste. Brushing: Brushing the teeth 2x a day for 4 weeks.	Commercial Toothpaste n=39 Participants Brushing twice a day with a commercially available toothpaste. Brushing: Brushing the teeth 2x a day for 4 weeks.
Gingival Index	0 score on a scale Standard Deviation 0	0 score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: 4 weeks

Patients with self-reported dentin hypersensitivity will be considered. A 1-s air blast from approximately 1 cm distance will be applied onto exposed dentine. The participant's response will be assessed using the 4-point Schiff Sensitivity Scale (from 0: participant does not respond, to 3: participant responds to stimulus, considers it painful, and requests discontinuation;

Outcome measures

Outcome measures
Measure	Recently Introduced Toothpaste n=46 Participants Brushing twice a day with a recently introduced toothpaste. Brushing: Brushing the teeth 2x a day for 4 weeks.	Commercial Toothpaste n=39 Participants Brushing twice a day with a commercially available toothpaste. Brushing: Brushing the teeth 2x a day for 4 weeks.
Dentin Hypersensitivity	0.19 units on a scale Standard Deviation 0.1	0.2 units on a scale Standard Deviation 0.1

SECONDARY outcome

Timeframe: 4 weeks

Participants' satisfaction before and after treatment will be recorded and the difference will be assessed. In order to obtain the data concerning patients' satisfaction with tooth color, a questionnaire containing aesthetic numeric visual-analogue scale ranging from 1 to 10 will be given to the subjects. 1 = "Not satisfied at all" and 10 = "Very satisfied"

Outcome measures

Outcome measures
Measure	Recently Introduced Toothpaste n=46 Participants Brushing twice a day with a recently introduced toothpaste. Brushing: Brushing the teeth 2x a day for 4 weeks.	Commercial Toothpaste n=39 Participants Brushing twice a day with a commercially available toothpaste. Brushing: Brushing the teeth 2x a day for 4 weeks.
Tooth Colour	8 units on a scale Standard Deviation 0.5	7.8 units on a scale Standard Deviation 0.5

Adverse Events

Recently Introduced Toothpaste

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Commercial Toothpaste

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

Prof. Lorenzo Breschi

DIBINE, University of Bologna

Phone: +393482210664

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place