Evidence map›Paper›PMID 37533523›Full record

Trial reportFrontiers in public health2023

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

Elzbieta Paszynska, Malgorzata Pawinska, Joachim Enax, Frederic Meyer, Erik Schulze Zur Wiesche, Theodor W May, Bennett T Amaechi, Hardy Limeback, Amadeusz Hernik, Justyna Otulakowska-Skrzynska and 5 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in Frontiers in public health, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04756557 (Caries-preventing Effect of a Hydroxyapatite-toothpaste in Adults), which is not on this map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
5.9field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04756557 nacompletednot on this map

Caries-preventing Effect of a Hydroxyapatite-toothpaste in Adults

TypeinterventionalSponsorPoznan University of Medical SciencesRan2021 to 2023Enrolled192ConditionsDental Caries, Hydroxyapatite, Tooth Decay, Dentin, CariousArmsExperimental., Active comparator
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 27 citations in OpenAlex.

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  15. Caries Etiology and Preventive Measures.European journal of dentistry · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 6 institutions in 4 countries.

Elzbieta PaszynskaDepartment of Integrated Dentistry, Poznan University of Medical Sciences, Poznan, Poland.
Malgorzata PawinskaDepartment of Integrated Dentistry, Medical University of Bialystok, Bialystok, Poland.
Joachim EnaxResearch Department, Dr. Kurt Wolff GmbH & Co. KG, Bielefeld, Germany.
Frederic MeyerResearch Department, Dr. Kurt Wolff GmbH & Co. KG, Bielefeld, Germany.
Erik Schulze Zur WiescheResearch Department, Dr. Kurt Wolff GmbH & Co. KG, Bielefeld, Germany.
Theodor W MaySociety for Biometrics and Psychometrics, Bielefeld, Germany.
Bennett T AmaechiDepartment of Comprehensive Dentistry, School of Dentistry, University of Texas Health San Antonio, San Antonio, TX, United States.
Hardy LimebackFaculty of Dentistry, University of Toronto, Toronto, ON, Canada.
Amadeusz HernikDepartment of Integrated Dentistry, Poznan University of Medical Sciences, Poznan, Poland.
Justyna Otulakowska-SkrzynskaDepartment of Integrated Dentistry, Poznan University of Medical Sciences, Poznan, Poland.
Anna KrahelDepartment of Integrated Dentistry, Poznan University of Medical Sciences, Poznan, Poland.
Inga KaminskaDepartment of Integrated Dentistry, Medical University of Bialystok, Bialystok, Poland.
Joanna Lapinska-AntonczukDepartment of Integrated Dentistry, Medical University of Bialystok, Bialystok, Poland.
Ewa StokowskaDepartment of Gerostomatology, Medical University of Bialystok, Bialystok, Poland.
Maria GawriolekDepartment of Integrated Dentistry, Poznan University of Medical Sciences, Poznan, Poland.
Poznan University of Medical Sciences · PLMedical University of Białystok · PLDr. August Wolff (Germany) · DEThe University of Texas Health Science Center at San Antonio · USUniversity of Toronto · CAZimmer Biomet (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Dental CariesToothpastesAdultCariostatic AgentsDental Caries SusceptibilityDurapatiteFluoridesHumansCariostatic AgentsDurapatiteFluoridesToothpastesadultsDecayed Missing Filled Surfaces (DMFS) indexdental cariesfluoridehydroxyapatitepublic healthrandomized clinical trial (RCT)toothpaste

Identifiers

PMID37533523
PMCPMC10393266
OpenAlexW4384698826

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.