An interventional study of Brushing in Caries and Gingivitis, sponsored by University of Bologna. Completed at 1 site in Italy. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-29.
Sponsored by University of Bologna · Not applicable, Interventional, and Prevention
The primary objective of this randomized controlled clinical trial (RCCT) will be to compare the efficacy in reducing the quantity of Streptococcus mutans (S. Mutans) in saliva of a recently introduced toothpaste compared to a commercially available toothpaste. The secondary outcomes will be to assess patients' impression of the toothpastes (in terms of taste, satisfaction etc.), and to investigate potential changes in dentin hypersensitivity, plaque formation and gingival inflammation.
590 studies on the registry are indexed under Gingivitis; 104 are open to participants now.
This study's enrollment of 100 is above the median of 64 across 478 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →University of Bologna is the lead sponsor of 153 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Brushing twice a day with a recently introduced toothpaste.
Other: Brushing
Brushing twice a day with a commercially available toothpaste.
Other: Brushing
Brushing the teeth 2x a day for 4 weeks.
Bacterial Count of Streptococcus Mutans (S. Mutans)
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.
Time frame: 4 weeks
Plaque Index
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.
Time frame: 4 weeks
Gingival Index
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.
Time frame: 4 weeks
Dentin Hypersensitivity
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;
Time frame: 4 weeks
Tooth Colour
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"
Time frame: 4 weeks
| Milestone | Recently Introduced Toothpaste | Commercial Toothpaste |
|---|---|---|
| Started | 50 | 50 |
| Completed | 46 | 39 |
| Not completed | 4 | 11 |
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.
| log CFU/ml | Recently Introduced Toothpaste | Commercial Toothpaste |
|---|---|---|
| Bacterial Count of Streptococcus Mutans (S. Mutans) | 4.261 ± 0.0867 | 4.277 ± 0.0931 |
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.
| score on a scale | Recently Introduced Toothpaste | Commercial Toothpaste |
|---|---|---|
| Plaque Index | 0.1 ± 0.05 | 0.17 ± 0.1 |
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.
| score on a scale | Recently Introduced Toothpaste | Commercial Toothpaste |
|---|---|---|
| Gingival Index | 0 ± 0 | 0 ± 0 |
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;
| units on a scale | Recently Introduced Toothpaste | Commercial Toothpaste |
|---|---|---|
| Dentin Hypersensitivity | 0.19 ± 0.1 | 0.2 ± 0.1 |
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"
| units on a scale | Recently Introduced Toothpaste | Commercial Toothpaste |
|---|---|---|
| Tooth Colour | 8 ± 0.5 | 7.8 ± 0.5 |
Collected over Up to 4 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Recently Introduced Toothpaste | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Commercial Toothpaste | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Age, Categorical(Participants) | Recently Introduced Toothpaste | Commercial Toothpaste | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 50 | 50 | 100 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Recently Introduced Toothpaste | Commercial Toothpaste | Total |
|---|---|---|---|
| Mean | 25.7 ± 0.3 | 25.3 ± 0.4 | 25.5 ± 0.35 |
| Sex: Female, Male(Participants) | Recently Introduced Toothpaste | Commercial Toothpaste | Total |
|---|---|---|---|
| Female | 29 | 26 | 55 |
| Male | 21 | 24 | 45 |
| Race and Ethnicity Not Collected(Participants) | Recently Introduced Toothpaste | Commercial Toothpaste | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Recently Introduced Toothpaste | Commercial Toothpaste | Total |
|---|---|---|---|
| Italy | 46 | 39 | 85 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Bologna