Innovation often starts at the coalface and usually in general practice. My story is to explain how difficult it is for a general practitioner to put innovation on a sound, scientific basis. If you want to know more, here is my story:
After having established that the Dentalfacelift procedure could rejuvenate the whole face, I observed that my patients’ faces continued to improve even years after treatment. Facelift dentistry is however an invasive and costly procedure. At the same time, I was observing that my patients’ faces were improving just by wearing the Oralift device before any work was done on the teeth. I was starting to doubt the need to embark on the invasive work on the teeth required for the Dentalfacelift. If the patient’s face could improve just by wearing the device, it seemed unjustifiable.
As with my previous work, it was paramount for me to put these findings on a scientific basis. In 2005, I started collecting data from fifty of my patients. When I showed their before and after photographs to a member of the panel who had been involved in the 2002 paper, she pointed out that because the changes were more subtle than the Dentalfacelift, it was important to further standardise my photography. As a general practitioner, I was not familiar with the protocol and strict standardisation required for measuring the changes to the skin.
Since I also own the patents of the device, I was concerned that my findings could be regarded as biased. My ideal way forward was to get a University to agree to a scientific trial but sadly, I failed. Each time I approached a professor, the answer was the same….it wasn’t their speciality. It seems that innovative work sometimes requires the creation of a speciality. Eventually, I did the secure the agreement of a consultant at King’s College Dental School to work with me. He would use his specialist knowledge of 3D imaging to measure changes on the face while I did the treatment on the patients. I believed I was moving towards the goal of an independent scientific study. The cost involved however meant that I could only do a pilot study.
Having completed the study, the next step was to write a paper with the aim of getting it published in a peer reviewed journal. Writing the paper raised another issue. I was told that I should have obtained ethical approval for this study. Clearly such issues are routine for the academic who is doing research in a university, but to me this presented a huge hurdle. I contacted the Chairman of the Ethics Committee who fortunately was able to assure me that this was not necessary as it was a regarded as a continuation of my previous work. A huge sigh of relief and the paper was then written. Little did I know that there were further hurdles ahead.
I soon became aware of the difficulties within the peer review system. In theory, peer review is excellent because the experts in the field are asked to look at the study, but when it is an entirely innovative treatment, where are the experts to be found? When I submitted my paper to various journals, the feedback that I received was that my work was not dentistry…and that a full double blind randomised controlled trial was needed. This had always been my aim but such a trial can cost hundreds of
Rather than continuing to try to get the paper published, I decided that perhaps the only way forward for such an innovative treatment was to find a way to secure the funding for a full trial. I knew from my experience with my first paper that it can be extremely difficult to secure funding.
Since I had the patents, I thought a partnership with a multinational might be the best option to secure funding. I approached a multinational who assured me that they would fund a trial. After four years of negotiations, it was clear that this was not going to be possible.
My quest to put this treatment on a scientific basis continued and during this time, I came to realise how the involvement of multinationals is compromising the research that is being done. This is happening not just in dentistry but in all scientific research. Scientific research has until recently been put on a pedestal by society, but now people are beginning to doubt the validity of so-called scientific trials that one day tell us we should drink x amount of alcohol, which soon afterwards is contradicted by some other trial.
Let me give a prime example of this. The control of gum disease is a crucial element of dentistry. We now know that unhealthy gums can play a significant part in a number of diseases and conditions. In the 1980’s I realised that our aim as dentists should be to eliminate all inflammation of the gums. My own anecdotal evidence had led me to conclude that this could be achieved by using interdental brushing alongside normal tooth brushing. I had found the use of dental floss to be inadequate. I was dismayed when the Cochrane Report of 2012 recommended flossing, as Cochrane was set up to evaluate the weight of research findings and provide health professionals and the public with the best advice.
I was encouraged when the European Federation of Periodontology published their report in 2015 concluding that daily interdental brushing rather than flossing was recommended.
How is a patient or indeed a dentist supposed to make an informed decision about which is more effective with such conflicting evidence? Television advertising would further have us believe that using certain tooth pastes and mouthwashes will eliminate gum disease. I have become a strong believer in restoring the independence of scientific research. It should not be compromised by tainted money.
My aim became two fold : to try to get the paper published and to think of a way how I could become involved in restoring the independence in scientific research.
Although my first paper had been published in 1996, and the technique has gathered momentum, it has not been universally adopted. It is frequently stated that innovative research takes an average of seventeen years before it reaches clinical practice. I believe this is not helped by the fact that the traditional peer reviewed journals are confined to subscribing members. I recently became aware of the steady growth of the open access journals and believed that this could be a means to accelerate the process. Acceptance of my paper by the Open Dentistry Journal concludes my story to date, but it has not finished. https://goo.gl/3Zn51u The Oralift Academy has been established to enable this treatment to be accessible to dentists worldwide, but also with the long term aim of helping to restore independence to scientific research by funding a programme of research.
I was fortunate to recently have the opportunity to work with Newable and the DIT who understood my passion and determination to continue with further research. I applied for a UK government Innovate UK smart grant but this was not successful, despite the support of the Universities of Birmingham and Oxford. I will not give up on this and my aim to develop an Oralift Medi version of the device.
We have recently launched a DIY Oralift with a connected App to guide the user through the treatment journey. This means that Oralift has the potential to be available anywhere in the world.
We recently did a trial with Cutest Ltd. This was a 2 week trial with 20 users. Conducting the trial was Stewart Long FRSC, a former President of the Society of Cosmetic Scientists conducted the trial. The findings are summarised here:
The undersigned hereby declare that this study was performed under our direction and in accordance with the procedures and undertakings specified in the study protocol. This report is a true and accurate record of the results obtained.
The practices and procedures adopted during the conduct of this study were consistent with the principles of ICH GCP and the guidelines for phase I clinical trials published by the Association of the British Pharmaceutical Industry (2007). All routine activities conducted during the course of the study were performed in accordance with Cutest Systems Ltd Standard Operating Procedures.
The primary objective of the study was to investigate the effects of using a facial rejuvenation device over a period of two weeks using instrumental, clinical and photographic assessments. The main questions being asked were:
The changes that are of relevance are the changes from Baseline to Baseline plus 15 minutes and the changes from Baseline to Plus two weeks. The statistically significant changes for these comparisons are as follows:
|Parameter||Baseline versus Baseline plus 15 minutes||Baseline versus Plus two weeks||% change baseline – 2 weeks|
|Canfield Wrinkles||Not significant||Significant||12.5%|
|Canfield Texture||Not significant||Significant||5%|
|Canfield Porphyrins||Significant (p = 0.0014)||Significant||3%|
|Canfield Red Areas||Not significant||Significant||9%|
|Canfield Brown Spots||Not significant||Significant||5%|
|Cutometer R5||Not significant||Significant||17%|
|Cutometer R7||Not significant||Significant||20%|
There was a noteworthy significant difference in several parameters associated with skin firmness, wrinkles and texture, indicating that long term use might lead to significant visible improvements. There were large changes in wrinkles of 12.5% and skin elasticity of 20% after only 2 weeks use of the product.
The Oralift device is intended to be a long term aid to improving facial appearance, including reducing some signs of premature aging. This pilot study has demonstrated some interesting benefits. Skin turnover is naturally around 4 weeks, therefore significant changes in skin appearance and physiology would be expected to be seen in timescales of 4-12 weeks for topical treatments. In this study, we saw that the initial use of the device (15 minutes after first use) led to a range of changes that suggest blood flow and skin physiological changes could have occurred. The study demonstrated a visible improvement in under eye wrinkles and some changes in skin elasticity, consistent with such a change. Furthermore, volunteers reported changes in skin firmness and to the under eye region (as well as other parameters) that are in agreement with the main clinical findings. Only two volunteers showed any signs of over use of the device, confirming that it is suitable for use by the majority of consumers without risk.
In conclusion, this study has shown some interesting evidence of changes in skin physiology that have led to improvement wrinkles, texture, skin elasticity and other parameters in a 2-week study, suggesting that long term use of the device may provide visible improvements in the signs of skin ageing.