CATEGORY 58 AUSTRALASIAN DENTIST Reconstitution of botulinum toxin is often treated as a routine step in clinical practice. However, what you reconstitute with – and how you choose your dilution – has direct implications for patient comfort, product longevity, and clinical outcomes. While the process may appear simple, it sits at the intersection of regulatory guidance, scienti c evidence, and evolving community standards. Understanding this distinction is essential for any practitioner aiming to practise safely, e ectively, and with con dence. Why Do Manufacturers Recommend Non-Preserved Saline? All botulinum toxin products approved by the TGA and FDA – such as Botox, Xeomin, Letybo, and Nuceiva – recommend reconstitution with non-preserved (plain) 0.9% saline. is is clearly stated in the product information and package inserts. en if we look at Daxxify and Dysport, they have entirely di erent recommendations. It is important to note that many dentists are currently unknowingly reconstituting Dysport in an o -label way, and not consenting their patients accordingly. e reason for this is not necessarily because non-preserved saline is superior, but because this is what was used in the original clinical trials submitted for regulatory approval. Pharmaceutical companies are legally bound to provide guidance that re ects the conditions under which their products were studied. ey are not permitted to recommend alternative methods that fall outside of their approved data, even if subsequent research supports those methods. is means that while clinicians often ask, “Why don’t manufacturers recommend bacteriostatic saline?”, the answer lies in regulatory limitation – not clinical inferiority. The Role of Community Standard Once a product enters the market, the scienti c community begins to build upon the initial data. is includes large-scale, peer-reviewed, randomised controlled trials that explore variations in technique, dosing, and reconstitution. Over time, when consistent ndings emerge and are supported by robust evidence, these practices become part of the community standard. is is precisely what has occurred with the use of 0.9% bacteriostatic saline for toxin reconstitution. Why Most Practitioners Use Bacteriostatic Saline In contemporary practice, many clinicians preferentially use sterile 0.9% bacteriostatic saline rather than non-preserved saline. is is supported by both evidence and practical considerations. One of the most immediate and clinically relevant bene ts is reduced injection pain. Bacteriostatic saline contains a small amount of benzyl alcohol, which acts as a local anaesthetic. Studies have demonstrated that patients consistently report less discomfort when toxin is reconstituted with bacteriostatic saline compared to non-preserved saline. In fact, early consensus work and comparative studies showed that up to 100% of patients preferred injections with preserved saline, with the majority reporting a noticeable reduction in pain. From a patient experience perspective, this is a meaningful advantage. Longevity and Practical Use in Clinic Another key consideration is product stability after reconstitution. When non-preserved saline is used, the general recommendation is that the toxin should be used within 24 hours, with any remaining product discarded thereafter. is recommendation is largely driven by concerns around sterility rather than loss of e cacy. In contrast, when bacteriostatic saline is used, evidence suggests that the toxin remains viable for up to 28 days when stored appropriately. Importantly, studies indicate that the toxin does not lose clinical e cacy over this period. e limiting factor is not degradation of the neurotoxin, but rather the risk of bacterial contamination over time. For many practices – particularly those with lower patient volumes – this extended usability is highly practical. It reduces wastage, improves cost e ciency, and allows for more exible treatment scheduling. However, it is critical to emphasise that this extended timeframe is contingent on maintaining strict aseptic technique and appropriate storage conditions. Additionally that are a number of variables that can make this timeframe not reliable, such as fridge temperature, handling of the product and saline viability. Reconstituting Botulinum Toxin: What to use, why it matters, and how to do it well CLINICAL Dr Giulia D’Anna By Dr Giulia D’Anna Founder, Dermal Distinction Academy Complications Expert – Aesthetic Medical Emergency Team (AMET)
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