International Clinical Trials Day 2021

We take a look at some of the funded clinical trials the School of Clinical Dentistry and Sheffield Teaching Hospital are involved in.

Dental School building

Today is International Clinical Trials Day, an annual celebration of what is believed to be the date when the first controlled clinical trial was conducted by James Lind in 1747.

Trials to prevent and manage tooth decay

BRIGHT Trial: Brushing RemInder 4 Good oral HealTh: the clinical and cost-effectiveness of a Short Messaging Service behaviour change programme to improve the oral health of young people living in deprived areas 

Run in secondary schools in areas of deprivation, BRIGHT will test whether a lesson about dental health followed by a series of text messages to young people aged 11-13 years reduces tooth decay, increases how often (and how well) they brush their teeth and would be of enough benefit to ensure it was worth the cost of running it. https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3538-6

SCRIPT Trial: Selective Caries Removal in Permanent Teeth 

There are different ways of treating tooth decay, with the most common being to take away all the decay and replacing it with a filling.  This can cause serious damage to the nerve, which may result if root canal treatment or tooth removal.  Dentists are researching new methods of treating tooth decay and SCRIPT compares partial with complete removal of tooth decay in adult teeth, and the effect the treatment has on the tooth’s health, need for further treatment, cost, pain experience and impact on patients quality of life.  

PIP Trial: Pulpotomy for the management of irreversible pulpitis in mature teeth (Pulpotomy for Irreversible Pulpitis - PIP Trial) 

When tooth decay spreads deep into a tooth it can cause irreversible damage, resulting in costly and timely root canal treatment.  An alternative to root canal treatment is a pulpotomy which involves only the damaged part of the nerve being removed and the tooth being sealed, a much quicker and easier treatment.  PIP aims to investigate pulpotomy versus root canal treatment and the effect on patients’ pain and anxiety, treatment satisfaction and cost.   

Trials to reduce anxiety

MAGIC Trial: The MAGIC trial (Melatonin for Anxiety prior to General anaesthesia In Children): A Multicentre, Parallel Randomised Controlled Trial of Melatonin Versus Midazolam in the Premedication of Anxious Children Attending for Elective Dental and ENT Surgery Under General Anaesthesia 

The MAGIC trial is comparing melatonin with midazolam as a premedication in anxious children undergoing general anaesthetic. Children with high levels of anxiety are currently offered midazolam as a premedication to reduce anxiety ahead of surgery, however it can have side effects including loss of coordination, risks to breathing and causes some children to become overexcited.  Melatonin, offers the same calming effects without the undesirable side effects, and the aim of MAGIC is to determine whether melatonin offers a better premedication than midazolam.  

CALM Trial: The CALM trial: the clinical and cost-effectiveness of a guided self-help cognitive behavioural therapy intervention to reduce dental anxiety in children

Around one in three children are scared of going to the dentist and end up with toothache, dental infections and tooth decay. CALM, starting in September 2021, will involve 600 children from 30 dental practices/clinics across England and Wales. CALM will examine whether specially developed, child friendly resources for children, parents and dental professionals will help reduce children’s dental anxiety, enable them to complete their dental treatment at their family practice rather than requiring specialist services for sedation or general anaesthetic. 

Both MAGIC and CALM are led from the School of Clinical Dentistry and sponsored by Sheffield Teaching Hospital.

Support stopping smoking

ENHANCE-D Trial: ENHANCing smoking cEssation interventions in Dentistry 

Smoking affects both general and oral health, and is one of the main risk factors for gum disease (periodontitis) and mouth and throat cancers.  Affecting 1 in 10 adults in the UK, periodontitis often leads to tooth loss, however smoking cessation can greatly improve oral health and dental treatments. ENHANCE-D, starting in the summer of 2021, aims to investigate whether the level of support (very brief advice) and smoking cessation medication (nicotine replacement therapy or e-cigarette) patients receive improves smoking quit rates and oral health, and whether providing this support is cost effective. 

Treat mucosal conditions

A Randomized, Double-blind, Placebo-controlled, Parallel Group Clinical Study to Assess the Safety and Efficacy of Three Doses of Clobetasol Propionate when Administered Intra-orally Twice Daily in Patients with Oral Lichen Planus (OLP) using Rivelin®-CLO Patches 

Phase two clinical trials have recently been completed investigating whether a unique plaster developed through a close collaboration between School of Clinical Dentistry scientists, Sheffield Teaching Hospital clinicians and colleagues at AFYX Therapeutics, are successful at treating the mucosal condition oral lichen planus.  

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