Trial reportBMC infectious diseases2017
A multicentre double-blind randomised controlled trial evaluating the efficacy of daily use of antibacterial mouthwash against oropharyngeal gonorrhoea among men who have sex with men: the OMEGA (Oral Mouthwash use to Eradicate GonorrhoeA) study protocol.
Trial report in BMC infectious diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
What it found
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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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 47 citations in OpenAlex.
- An open-label, parallel-group, randomised controlled trial of antiseptic mouthwash versus antibiotics for oropharyngeal gonorrhoea treatment (OMEGA2).Scientific reports · 2020Trial
- Understanding Risk Factors for Oropharyngeal Gonorrhea Among Sex Workers Attending Sexual Health Clinics in 2 Australian Cities: Mixed Methods Study.JMIR public health and surveillance · 2024Article
- Gonorrhea caused due to antimicrobial-resistant bacteriaIn silico pharmacology · 2024Article
- Anti-Virulence Therapeutic Approaches forAntibiotics (Basel, Switzerland) · 2021Review
- Associations between oral sex practices and frequent mouthwash use in heterosexuals: a cross-sectional survey in Melbourne, Australia.BMJ open · 2021Article
- Duration of gargling and rinsing among frequent mouthwash users: a cross-sectional study.BMJ open · 2020Article
- Article
- The frontiers of addressing antibiotic resistance in Neisseria gonorrhoeae.Translational research : the journal of laboratory and clinical medicine · 2020Review
- CommensalPathogens (Basel, Switzerland) · 2020Article
- Construction and optimization of a 'NG Morbidostat' - An automated continuous-culture device for studying the pathways towards antibiotic resistance inF1000Research · 2019Article
- The development of mouthwashes without anti-gonococcal activity for controlled clinical trials: an in vitro study.F1000Research · 2019Article
- Concordance of gonorrhoea of the rectum, pharynx and urethra in same-sex male partnerships attending a sexual health service in Melbourne, Australia.BMC infectious diseases · 2018Article
- Kiss and Tell: Limited Empirical Data on Oropharyngeal Neisseria gonorrhoeae Among Men Who Have Sex With Men and Implications for Modeling.Sexually transmitted diseases · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
23 authors at 8 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundGonorrhoea is one of the most common sexually transmissible infections in men who have sex with men (MSM). Gonorrhoea rates have increased substantially in recent years. There is concern that increasing gonorrhoea prevalence will increase the likelihood of worsening antibiotic resistance in Neisseria gonorrhoeae. A recent randomised controlled trial (RCT) demonstrated that a single-dose of mouthwash has an inhibitory effect against oropharyngeal gonorrhoea. We are conducting the first RCT to evaluate whether daily use of mouthwash could reduce the risk of acquiring oropharyngeal gonorrhoea. METHODS/
designThe OMEGA (Oral Mouthwash use to Eradicate GonorrhoeA) study is a double-blind RCT and will be conducted at several sexual health clinics and high caseload General Practice (GP) clinics in Melbourne and Sydney, Australia. A total of 504 MSM attending the participating sites will be recruited. Participants will be randomised to either using 'Study mouthwash A' or 'Study mouthwash B' for 12 weeks. Study mouthwash A was inhibitory against N. gonorrhoeae in vitro, whereas study mouthwash B was not. Participants will be instructed to rinse and gargle the study mouthwash for 60 seconds every day. The primary outcome is the proportion of participants with oropharyngeal gonorrhoea detected by nucleic acid amplification test by 12 weeks. DISCUSSION: The results from this trial may provide a novel way to reduce gonorrhoea prevalence and transmission without the use of antibiotics that may be associated with development of resistance. If shown to be effective, the widespread use of mouthwash will reduce the prevalence of oropharyngeal gonorrhoea, which plays key role in driving the emergence of gonococcal antimicrobial resistance through DNA exchange with oral commensal bacteria. The anticipated net effect will be interruption of onward transmission of N. gonorrhoeae within high density sexual networks within MSM populations.
trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12616000247471 , registered on 23rd February 2016.
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