ReviewInternational endodontic journal2025
Regulatory issues related to the use of sodium hypochlorite solutions in endodontics.
Review in International endodontic journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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.
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
3 citing papers in PubMed.
- Postoperative pain after single visit root canal treatment using domestic vs. medical grade sodium hypochlorite: a randomized controlled trial.BMC oral health · 2026Trial
- Dissolution versus dislodgment of dentin debris by pulsed erbium-doped yttrium aluminum garnet laser-activated endodontic irrigants.Lasers in medical science · 2026Article
- Regulatory issues related to the use of sodium hypochlorite solutions in endodontics.International endodontic journal · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimTo assess the regulation of sodium hypochlorite (NaOCl) solutions for endodontic usage in some of the world's main dental markets, in view of the European Union's recent move to classify antimicrobial root canal irrigants as high-risk devices under their Medical Device Regulation (MDR). METHODOLOGY: The authors consulted legal texts available online and communicated with local health authorities wherever necessary to assess into which medical device category NaOCl solutions intended for endodontic application were subsumed. Furthermore, it was investigated whether there were sources outside the dental market to obtain NaOCl solutions for root canal treatments.
resultsUpon completion of this text (mid 2024), NaOCl solutions for root canal irrigation had not been classified in the US and Canada, whilst in the European Union, they had just been upgraded to high-risk medical devices, with all the consequences for the dental supply market. This MDR rule was adopted by the EU's close trading partners, the United Kingdom, Switzerland and Turkey. In Japan, the legal hurdles were already high for manufacturers and importers of endodontic NaOCl solutions. Conversely, in China, these solutions were down-graded from a high-risk to a medium-risk status in 2017. A low-medium risk category was applied in the other countries under investigation, that is, Australia, India and Brazil. In some countries there was a possibility for dentists to procure plain NaOCl solutions from pharmacies. An alternative route to avoid buying NaOCl from dental suppliers was to use (household) bleach solutions for root canal irrigation wherever this practice was not prohibited explicitly.
conclusionsThe legal situation to produce, import and use NaOCl solutions for root canal irrigation differs vastly around the globe. A sensible approach to regulate (yet not over-regulate) endodontic NaOCl solutions appears to be timely and necessary.
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Identifiers
What OpenQuestion holds
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.