Dental Tribune United Kingdom Edition

Product recall of Sensodyne Repair & Protect Batch No 031G only GlaxoSmithKline Consumer Healthcare is taking the precautionary measure to recall Batch No 031G of Sensodyne Repair & Protect, a dentine tubule occluding toothpaste for the treatment of dentine hypersensitivity. It has come to our attention through consumer reports and now from our own thorough investigations that this batch contains some larger (1 – 2 mm) particles of the occluding material (calcium sodium phosphosilicate – NovaMin™– normal particle size range typically less than 75 microns).These larger particles are noticeable by the end user. GSK’s investigation concluded that these larger particles may scratch the gums when brushing, which may cause the gums to bleed.Therefore GSK will be taking the precautionary measure to recall this batch. Only a very small number of such cases have been reported. Patients have been advised to contact their dentist if they experience bleeding from the gums after using this product. We regret any inconvenience this may cause. What you/your patients should do: • If you/your patient have a pack of Sensodyne Repair & Protect please check to see if it is Batch No 031G • If you have Batch No 031G please stop using it and return any packs (used or unused) to the following address for a refund: Consumer Affairs Dept (Sensodyne) GlaxoSmithKline Consumer Healthcare Brentford TW8 9GS • Please enclose your contact details in the envelope • If you have any questions please call the freephone number below • If the batch code is NOT 031G then you do not need to take any action Freephone helpline: 0800 652 4500 8.30am-6pm Monday to Friday with an answer phone outside of these hours Consumer health and safety is of upmost importance to GSK. LOT031G EXP 2012 12 LOT031G P1 OR LOT031G P2 7OpinionMay 23-29, 2011United Kingdom EditionUnited Kingdom Edition T his may seem like a strange question, be- cause of course anything that raises awareness to and im- proves oral healthcare must be good, right? I mean, who could argue with the mountain of evi- dence supporting fluoridated toothpastes in reducing caries rates, or even the efficacy of anti plaque agents such as chlorhexi- dine in reducing plaque levels? Now the manufacturers of many of these products are very quick to promote their semi-medici- nal nature, but unlike regulated medicines, very little emphasis is given to the risks. ‘Sufficient evidence’ A literature review by McCul- lough and Farah (Dental Journal of Australia, 2008) concluded that there is “sufficient evidence” that “alcohol-containing mouthwash- es contribute to the increased risk of development of oral cancer”. The authors also state that the risk of acquiring cancer rises al- most five times for users of alco- hol-containing mouthwash who neither smoke nor drink (with a higher rate of increase for those who do). Whilst this was disputed by Yinka Ebo of Cancer Research UK, who concluded that “there is still not enough evidence to sug- gest that using mouthwash that contains alcohol will increase the risk of mouth cancer”, many brands have now introduced al- cohol-free ranges. Whilst the risk of oral cancer has been much debated, concerns have also been raised about the effects of dryness when using an alcohol containing mouthwash and the actual effectiveness at combating halitosis. Leaving the content of the products aside, what exactly is their contribution towards oral health? Of course many brands heavily promote clinical stud- ies that clearly point to improve- ments in gingival health, but these tend to be for patients with- out severe periodontal disease (a fact often omitted) and often slogans such as ‘nothing is more effective for gum problems’ and ‘kills 99.9 per cent of bacteria’ strongly imply that patients may be able to effectively self treat. The US Food and Drugs Agency (FDA) seem to disagree with many of the claims made by the manufacturers and the FDA has warned manufacturers such as Walgreen Co Johnson & Johnson, and CVS Corp to stop making unproven claims that their mouth rinse products can reduce plaque above the gum line, promote gum health, and prevent gum disease. The com- panies claim their mouthwash- es are effective in preventing gum disease, but according to the FDA no such benefit has been demonstrated. On a different note, it is worth questioning whether the ter- minology used by mouthwash brands helps or hinders the population’s ability to maintain their own oral hygiene. Consider for instance the slogan ‘bleeding gums are bad’. At first glance this seems hard to argue against, but if we look at when people actually see their gums bleed, ie during brushing and interspace clean- ing, all of a sudden this state- ment takes a different turn. Could these sorts of messages hinder our patients from decent gingival brushing when cleaning? And if, so do the benefits of using a mouthwash outweigh the risks of poor tooth brushing? Why use it? So why do we all use mouth- wash? Well I often use mouth- wash during the day, but mostly to freshen my breath either after lunch or if I am in a rush. Many people use mouthwash after brushing their teeth, but in the process however wash off much of the proven benefits of their fluoridated toothpaste. Others purposefully buy mouthwash on the basis of improving their breath, especially on waking up, to get rid of the so called ‘morn- ing breath’. A panel compiled by the FDA reported that bad breath in the morning is something most people have, but it doesn’t indi- cate an oral disease. According to the panel, most people can solve their breath problems by rinsing their mouths with water, brush- ing their teeth, flossing, or simply eating breakfast. Now of course, this doesn’t detract from the many of the ad- vances made with anti-plaque and anti-gingivitis agents such as with chlorhexidine, essential oils, triclosan etc; but how effective are these products when stacked up against thorough cleaning? Are they actually needed or help- ful in the presence of decent oral cleaning? Furthermore, if it is not as helpful to our patients as the claims suggest, could this hinder some of our patients’ oral hygiene routine by convincing them that they are doing everything they can to look after their teeth and leading them to a cost ineffective dependency? Child ranges Many leading manufacturers are introducing children’s ranges of mouthwashes, again with much of the same rhetoric around kill- ing bacteria and carefully worded implications surrounding pre- venting oral health problems. Many of the studies used by the mouthwash manufacturers point to improvements when looking at mouthwashes being used as an adjunct to decent oral clean- ing, but there is very little evi- dence supporting the use in the presence of poor cleaning or as a substitute for good oral hygiene. Whilst the ‘help’ that they claim to offer to families is heavily ad- vertised, perhaps mouth washing post brushing (hence rinsing of fluoridated toothpaste) for a high caries risk child may actually be a hindrance. Whilst organisations such as the FDA have acted to rep- rimand companies for making false claims, this in itself does not prove harm or a causal link to those patients to choose to stay away from gingival brushing and flossing because they mis- interpret slogans such as ‘bleed- ing gums are bad’ or ‘cleans the whole mouth’. However, this does lead me back to the original ques- tion: are mouthwashes actually a help or a hindrance? Of course, in some situations they can be very useful and many dentists often recommend these products with good results, but this is marred by a plethora of quasi-scientific claims which, rather than em- phasise their limited usefulness, imply to many that they are a ad- equate replacement to decent oral cleaning. DT Mouthwashes: help or hindrance? Neel Kothari discusses the contribution of mouthwashes to oral health About the author Neel Kothari qualified as a den- tist from Bristol University Dental School in 2005, and currently works in Sawston, Cam- bridge as a princi- pal dentist at High Street Dental Prac- tice. He has com- pleted a year-long postgraduate certifi- cate in implantology and is currently undertaking the Diploma in Implantol- ogy at UCL’s Eastman Dental Institute. ‘It is worth questioning whether the termi- nology used by mouthwash brands helps or hinders the population’s ability to maintain their own oral hygiene’