Evidence map›Paper›PMID 38762482›Full record

Trial reportBMC oral health2024

Quantitative analysis of the effects of essential oil mouthrinses on clinical plaque microbiome: a parallel-group, randomized trial.

Kyungrok Min, Andrew J Glowacki, Mary Lynn Bosma, James A McGuire, Sandy Tian, Kathleen McAdoo, Alicia DelSasso, Tara Fourre, Robert J Gambogi, Jeffery Milleman and 1 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC oral health, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04921371 (Six Week Safety and Clinical Efficacy of Experimental Mouth Rinses), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
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.

NCT04921371 phase1completednot on this map

Six Week Safety and Clinical Efficacy of Experimental Mouth Rinses: Effect on Gingivitis and Plaque

TypeinterventionalSponsorJohnson & Johnson Consumer Inc. (J&JCI)Ran2019 to 2019Enrolled157ConditionsGingivitis, PlaqueArmsColgate® Cavity Protection Toothpaste, Listerine® Cool Mint®, Concept Curve Winter Series Toothbrush, 5% Hydroalcohol Mouthrinse, Mouthrinse Prototype 1
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
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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

11 authors.

Kyungrok MinJohnson & Johnson Consumer Inc, Skillman, NJ, USA. kmin4@kenvue.com.
Andrew J GlowackiJohnson & Johnson Consumer Inc, Skillman, NJ, USA.
Mary Lynn BosmaJohnson & Johnson Consumer Inc, Skillman, NJ, USA.
James A McGuireJohnson & Johnson Consumer Inc, Skillman, NJ, USA.
Sandy TianJohnson & Johnson Consumer Inc, Skillman, NJ, USA.
Kathleen McAdooJohnson & Johnson Consumer Inc, Skillman, NJ, USA.
Alicia DelSassoJohnson & Johnson Consumer Inc, Skillman, NJ, USA.
Tara FourreJohnson & Johnson Consumer Inc, Skillman, NJ, USA.
Robert J GambogiJohnson & Johnson Consumer Inc, Skillman, NJ, USA.
Jeffery MillemanSalus Research Inc, Fort Wayne, IN, USA.
Kimberly R MillemanSalus Research Inc, Fort Wayne, IN, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe rich diversity of microorganisms in the oral cavity plays an important role in the maintenance of oral health and development of detrimental oral health conditions. Beyond commonly used qualitative microbiome metrics, such as relative proportions or diversity, both the species-level identification and quantification of bacteria are key to understanding clinical disease associations. This study reports the first-time application of an absolute quantitative microbiome analysis using spiked DNA standards and shotgun metagenome sequencing to assess the efficacy and safety of product intervention on dental plaque microbiome.

methodsIn this parallel-group, randomized clinical trial, essential oil mouthrinses, including LISTERINE® Cool Mint Antiseptic (LCM), an alcohol-containing prototype mouthrinse (ACPM), and an alcohol-free prototype mouthrinse (AFPM), were compared against a hydroalcohol control rinse on clinical parameters and the oral microbiome of subjects with moderate gingivitis. To enable a sensitive and clinically meaningful measure of bacterial abundances, species were categorized according to their associations with oral conditions based on published literature and quantified using known amounts of spiked DNA standards.

resultsMultivariate analysis showed that both LCM and ACPM shifted the dysbiotic microbiome composition of subjects with gingivitis to a healthier state after 4 weeks of twice-daily use, resembling the composition of subjects with clinically healthy oral conditions recruited for observational reference comparison at baseline. The essential oil-containing mouthrinses evaluated in this study showed statistically significant reductions in clinical gingivitis and plaque measurements when compared to the hydroalcohol control rinse after 6 weeks of use.

conclusionsBy establishing a novel quantitative method for microbiome analysis, this study sheds light on the mechanisms of LCM mouthrinse efficacy on oral microbial ecology, demonstrating that repeated usage non-selectively resets a gingivitis-like oral microbiome toward that of a healthy oral cavity.

trial registrationThe trial was registered on ClinicalTrials.gov on 10/06/2021. The registration number is NCT04921371.

Indexed as

Dental PlaqueGingivitisMicrobiotaMouthwashesOils, VolatileAdultAnti-Infective Agents, LocalDrug CombinationsFemaleHumansMaleMiddle AgedSalicylatesTerpenesYoung AdultAnti-Infective Agents, LocalDrug CombinationsListerineMouthwashesOils, VolatileSalicylatesTerpenesEssential oilGingivitisListerineMouthrinseOral MicrobiomeQuantitative Microbiome

Identifiers

PMID38762482
PMCPMC11102605

What OpenQuestion holds

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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.