CariesNCT05569850
Efficacy of an Antibacterial Toothpaste and Patients' Satisfaction
A study testing Brushing in people with Caries and Gingivitis, run by University of Bologna at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries, Gingivitis
- What is being tested?
- Brushing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2022to 15 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with minimum 20 teeth;
- Good oral hygiene level (gingival bleeding index not exceeding 20%)
- Patients willing to participate in the study and able to sign an informed consent
Who cannot join
- Tooth anomalies (amelogenesis imperfecta, dentinogenesis imperfecta etc.);
- Intrinsic stain (fluorosis);
- Caries lesions;
- Advanced periodontal disease (probing >2, spontaneous gum bleeding, tooth mobility >1);
- Smokers;
- Use of orthodontic devices;
Show all 10Show fewer
- Use of antibiotics in the last 3 months;
- Use of antibacterial mouth rinses in the last 3 months;
- Potential allergies;
- Drug and alcohol abuse;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Vivo Evaluation of Antibacterial Toothpaste Efficiency and Patients' Satisfaction: a Double-blind Randomised Controlled Trial
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.
- Conditions
- Caries, Gingivitis
- Being tested
- Brushing
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrushingOther
Brushing the teeth 2x a day for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Recently introduced toothpaste | Experimental | Brushing twice a day with a recently introduced toothpaste. Receives: Other: Brushing |
| Commercial toothpaste | Active comparator | Brushing twice a day with a commercially available toothpaste. Receives: Other: Brushing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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;
Measured: 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"
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start1 Dec 2022
- Primary completion15 Jul 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Collaborators
- Unilever R&D
- Responsible party
- Principal investigator, Lorenzo Breschi, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569850
- Sponsor's protocol ID
- 2.2022.
- Status last verified
- Apr 2025
- First submitted
- 27 Sep 2022
- Last updated
- 29 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Josic U, Maravic T, Mazzitelli C, Rinaldi L, D'Alessandro C, D'Urso D, Pellegrino G, Mazzoni A, Breschi L. The clinical and microbiological efficacy of a zinc-citrate/hydroxyapatite/potassium-citrate containing toothpaste: a double-blind randomized controlled clinical trial. Clin Oral Investig. 2024 Nov 22;28(12):652. doi: 10.1007/s00784-024-06052-z.
PubMed 39572408
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Evaluation of Antibacterial Toothpaste Efficiency and Patients' Satisfaction: a Double-blind Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05569850
- Acronym / sponsor ID
- 2.2022.
- Conditions
- Caries, Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Collaborators
- Unilever R&D
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 6 Oct 2022 (actual)
- Results
- Posted 29 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recently introduced toothpaste | Experimental | Other: BrushingBrushing twice a day with a recently introduced toothpaste. |
| Commercial toothpaste | Active comparator | Other: BrushingBrushing twice a day with a commercially available toothpaste. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with minimum 20 teeth;
- Good oral hygiene level (gingival bleeding index not exceeding 20%)
- Patients willing to participate in the study and able to sign an informed consent
Key exclusion criteria (10 listed)
- Tooth anomalies (amelogenesis imperfecta, dentinogenesis imperfecta etc.);
- Intrinsic stain (fluorosis);
- Caries lesions;
- Advanced periodontal disease (probing >2, spontaneous gum bleeding, tooth mobility >1);
- Smokers;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrushingBrushing the teeth 2x a day for 4 weeks. | Other | Commercial toothpaste, Recently introduced toothpaste |
Primary outcome
Bacterial Count of Streptococcus Mutans (S. Mutans)
Time frame: 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.
4 secondary outcomes
Plaque Index
Time frame: 4 weeks
Gingival Index
Time frame: 4 weeks
Dentin Hypersensitivity
Time frame: 4 weeks
Tooth Colour
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39572408Josic U, Maravic T, Mazzitelli C, Rinaldi L, D'Alessandro C, D'Urso D, Pellegrino G, Mazzoni A, Breschi L. The clinical and microbiological efficacy of a zinc-citrate/hydroxyapatite/potassium-citrate containing toothpaste: a double-blind randomized controlled clinical trial. Clin Oral Investig. 2024 Nov 22;28(12):652. doi: 10.1007/s00784-024-06052-z.
- Individual participant dataSharing planned: Undecided
Related trials for Caries
Active, not recruiting
Trial With Two New Tooth-colored Restorative Materials in Class I/II Cavities
Caries, Defective Restorations
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruitingObservational study
Diagnostic Performance of Ai vs Junior Dentists
Diagnosis
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brushing in people with Caries and Gingivitis, run by University of Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial Count of Streptococcus Mutans (S. Mutans) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05569850, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.