Dataset Information

Caries-preventing effect of a hydroxyapatite-toothpaste in adults: a 18-month double-blinded randomized clinical trial.

ABSTRACT:

Background

Dental caries is a worldwide challenge for public health. The aim of this 18-month double-blinded, randomized, clinical trial was to compare the caries-preventing effect of a fluoride-free, hydroxyapatite toothpaste (test) and a toothpaste with sodium fluoride (1450 ppm fluoride; positive control) in adults.

Methods

The primary endpoint was the percentage of subjects showing no increase in overall Decayed Missing Filled Surfaces (DMFS) index. The study was designed as non-inferiority trial. Non-inferiority was claimed if the upper limit of the exact one-sided 95% confidence interval for the difference of the primary endpoint DMFS between test and control toothpaste was less than the predefined margin of non-inferiority (Δ ≤ 20%).

Results

In total, 189 adults were included in the intention-to-treat (ITT) analysis; 171 subjects finished the study per protocol (PP). According to the PP analysis, no increase in DMFS index was observed in 89.3% of subjects of the hydroxyapatite group and 87.4% of the subjects of the fluoride group. The hydroxyapatite toothpaste was not statistically inferior to a fluoride toothpaste with regard to the primary endpoint.

Conclusion

Hydroxyapatite was proven to be a safe and efficient anticaries agent in oral care.

Clinical trial registration

NCT04756557.

SUBMITTER: Paszynska E

PROVIDER: S-EPMC10393266 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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Publications

Caries-preventing effect of a hydroxyapatite-toothpaste in adults: a 18-month double-blinded randomized clinical trial.

Paszynska Elzbieta E Pawinska Malgorzata M Enax Joachim J Meyer Frederic F Schulze Zur Wiesche Erik E May Theodor W TW Amaechi Bennett T BT Limeback Hardy H Hernik Amadeusz A Otulakowska-Skrzynska Justyna J Krahel Anna A Kaminska Inga I Lapinska-Antonczuk Joanna J Stokowska Ewa E Gawriolek Maria M

Frontiers in public health 20230718

<h4>Background</h4>Dental caries is a worldwide challenge for public health. The aim of this 18-month double-blinded, randomized, clinical trial was to compare the caries-preventing effect of a fluoride-free, hydroxyapatite toothpaste (test) and a toothpaste with sodium fluoride (1450 ppm fluoride; positive control) in adults.<h4>Methods</h4>The primary endpoint was the percentage of subjects showing no increase in overall Decayed Missing Filled Surfaces (DMFS) index. The study was designed as n ...[more]

PMID: 37533523

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Project description:(1) Background: Dental calculus works as a niche wherein pathogenic bacteria proliferate in the oral cavity. Previous studies revealed the anticalculus activity of pyrophosphates, however there was no clinical study that evaluated microbiome changes associated with calculus inhibition. Therefore, the aim of this randomized clinical trial was to evaluate the calculus inhibition of pyrophosphate-containing toothpaste and its effect on oral microbiome changes. (2) Methods: Eighty subjects with a calculus index ≥2 on the lingual of the mandibular anterior tooth were randomly allocated to the test group that pyrophosphate-containing toothpaste was given to or the placebo control group. Full mouth debridement and standardized tooth brushing instruction were given before the allocation. Plaque index, gingival index, calculus index, probing depth, and bleeding on probing were measured at the baseline, and at 4, 8 and 12 weeks. Genomic DNA was extracted from the plaque samples collected at the baseline and at 12 weeks, and 16S ribosomal RNA gene amplicon sequencing was applied for microbiome analysis. (3) Results: None of the clinical parameters showed significant differences by visits or groups, except the plaque index of the test group, which reduced significantly between 4 and 12 weeks. A significant difference of microbiome between the baseline and 12 weeks was observed in the test group. Between baseline and 12 weeks, the proportion of Spirochetes decreased in the control group, and the proportions of Proteobacteria, Fusobacteria and Spirochetes in the phylum level and the proportions of Haemophilus, Fusobacterium and Capnocytophaga in the genus level decreased in the test group. In the test group, as plaque index decreased, Streptococcus increased, and Fusobacterium and Haemophilus parainfluenza decreased. (4) Conclusion: The use of pyrophosphate-containing toothpaste effectively inhibited the dysbiosis of the oral microbiome and the proliferation of pathogenic species in periodontal disease. Clinically, plaque formation in the pyrophosphate-containing toothpaste group was effectively decreased, however there was no significant change in calculus deposition.

Project description:BackgroundModern toothbrushes origin can be traced to plant-derived chewing sticks, which were documented to be used Babylonians as early as 3500 BC. Chewing sticks are routinely used for cleaning teeth in Asia, Africa, South America, and the Middle East. The aim of the current study was to evaluate the antibacterial effect of miswak herbal toothpaste compared to fluoride toothpaste using a normal toothbrush, against Streptococcus mutans in high caries risk patients.Material and methodsA total of 32 participants were recruited to the current clinical trial using convenience sampling randomly either to miswak or fluoride toothpastes groups (n=16). The bacterial count represented as colony-forming units per milliliter (CFU/ml) was assessed at baseline and after 1 week, 1 month and 3 months. Moreover, the ion release for silicone, calcium, phosphorus, and fluoride from both toothpastes was analyzed in addition to the pH of both toothpastes and their supernatants. Intergroup comparison was performed using independent t test, while intragroup comparison was performed using repeated measures ANOVA followed by tukey post-hoc test and paired t test when appropriate.ResultsThere was no statistically significant difference between both toothpastes for the S. mutans count within each follow up period, however the bacterial count significantly decreased over time in both groups. Signal Fluoride toothpaste exhibited statistically significant higher ion release when compared to the Dabur Miswak toothpaste. There was no statistically significant difference between either toothpastes regarding pH (P = 0.5368), while comparison between supernatants of toothpastes have shown statistically significant difference (P = 0.0194), with a higher pH in miswak toothpaste.ConclusionsMiswak herbal toothpaste possesses a potent antibacterial effect, yet its remineralization potential is questionable due to its inferior ion release that will affect the ion substantivity in saliva, which is an important factor in remineralization. Key words:High caries risk, Miswak, Fluoride, Antibacterial, Streptococcus mutans.

Dataset Information

Caries-preventing effect of a hydroxyapatite-toothpaste in adults: a 18-month double-blinded randomized clinical trial.

Background

Methods

Results

Conclusion

Clinical trial registration

Publications

Caries-preventing effect of a hydroxyapatite-toothpaste in adults: a 18-month double-blinded randomized clinical trial.

Similar Datasets

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