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Randomized Controlled Trial
. 2024 Nov 22;28(12):652.
doi: 10.1007/s00784-024-06052-z.

The clinical and microbiological efficacy of a zinc-citrate/hydroxyapatite/potassium-citrate containing toothpaste: a double-blind randomized controlled clinical trial

Uros Josic  1 , Tatjana Maravic  1 , Claudia Mazzitelli  1 , Lorenzo Rinaldi  1 , Carlo D'Alessandro  1 , Diego D'Urso  1 , Gerardo Pellegrino  1 , Annalisa Mazzoni  1 , Lorenzo Breschi  2
Affiliations
Randomized Controlled Trial

The clinical and microbiological efficacy of a zinc-citrate/hydroxyapatite/potassium-citrate containing toothpaste: a double-blind randomized controlled clinical trial

Uros Josic et al. Clin Oral Investig. .

Abstract

Objectives: To evaluate the antibacterial efficacy of two fluoride-containing (1450 ppm F) toothpastes with or without zinc-citrate (ZCT), hydroxyapatite (HAP) and potassium-citrate (KCit); to assess and compare their clinical effects in terms of tooth sensitivity, plaque accumulation and gingivitis, as well as patients' satisfaction.

Materials and methods: Healthy, adult patients were selected and randomly assigned to two groups (n = 50): Experimental: ZCT-, HAP-, KCit- and fluoride-containing toothpaste; Control: fluoride-containing toothpaste. Salivary counts of Streptococcus mutans (S. mutans), plaque and gingival index, as well as clinically diagnosed sensitivity were recorded at baseline, and after 4 weeks. A custom-made questionnaire was used to assess patients' self-reported sensitivity (baseline and after 4 weeks) and overall satisfaction with the tested toothpastes. Data were statistically analyzed (α = 0.05).

Results: After 4 weeks, a statistically significant salivary reduction of S. mutans was observed in both groups (p = 0.001). Furthermore, the percentage of S. mutans decrease was significantly higher in Experimental group (p = 0.014). There were no statistically significant differences between the groups in terms of plaque and gingival index (p > 0.05). After 4 weeks, the self-reported tooth sensitivity was lower in Experimental group (p < 0.001).

Conclusions: Both toothpastes showed good antimicrobial effect after 4 weeks; however, the toothpaste containing ZCT, HAP, KCit and fluoride was found to be more effective in reducing the salivary counts of S. mutans than the product containing fluoride alone.

Clinical relevance: Toothpaste containing ZCT, HAP, KCit and fluoride can be recommended for patients at risk for developing caries and may also be beneficial for individuals experiencing dental sensitivity.

Keywords: Antimicrobial; Dentin sensitivity; Fluoride; Hydroxyapatite; Randomized clinical trial; Toothpaste; Zinc citrate.

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Conflict of interest statement

Declarations. Ethical approval: The study protocol was reviewed and approved by the University of Bologna Ethics Committee (793/2022/SPER/AUSLBO). Informed consent: A written informed consent was obtained from patients before their enrollment in the study. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Study flowchart
Fig. 2
Fig. 2
Demographic characteristics of patients enrolled in the study
Fig. 3
Fig. 3
CONSORT 2010 flow diagram
Fig. 4
Fig. 4
Mean amount of change in the logarithm of colony-forming units per milliliter (log CFU/mL) of S. mutans in salivary samples at baseline and at the end of the follow-up (4 weeks)
Fig. 5
Fig. 5
The percentage of S. mutans reduction (shown as purple) in salivary samples of patients in experimental and control toothpaste groups. In case of statistically significant differences between the groups (p < 0.05), an asterisk was placed next to the significantly higher value for the outcome
See this image and copyright information in PMC

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