N/A
N=100
Efficacy of an Antibacterial Toothpaste and Patients' Satisfaction
Caries · Gingivitis
Bottom Line
View on ClinicalTrials.gov: NCT05569850 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Bacterial Count of Streptococcus Mutans (S. Mutans) — 4.261; 4.277 log CFU/ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Brushing (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Bologna
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bacterial Count of Streptococcus Mutans (S. Mutans) |
4.261; 4.277 | — |
| SECONDARY Plaque Index |
0.1; 0.17 | — |
| SECONDARY Gingival Index |
0; 0 | — |
| SECONDARY Dentin Hypersensitivity |
0.19; 0.2 | — |
| SECONDARY Tooth Colour |
8; 7.8 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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;
- Use of antibiotics in the last 3 months;
- Use of antibacterial mouth rinses in the last 3 months;
- Potential allergies;
- Drug and alcohol abuse;
Data sourced from ClinicalTrials.gov (NCT05569850). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.