A pilot randomised controlled trial of coventional implants vs mini implants used to retain full lower dentures
|Pilot||Device||Closed||18 and over||Christie|| Eudract No:
Isrctn No: 87342238
There are 3.7 million people in Britain who have no natural teeth and most are over 65. Many of these individuals have difficulty wearing lower dentures, which causes difficulties in chewing and speaking resulting in a significant impact on quality of life, so much so that the World Health Organisation classifies these individuals as having a disability. Titanium implants screwed into the jaw hold lower dentures in place, but implants are costly and require surgery that some patients may not cope with. Mini-implants have recently been developed; they are smaller and cheaper than conventional implants and are much less traumatic to place. However, the long-term costs and benefits of mini-implants have not been compared with conventional implants in high quality clinical trials. High quality clinical trials are expensive and there is a lot of information missing which is needed to make sure a large trial can be completed cost-effectively. We therefore propose to undertake a pilot trial at Manchester University Dental Hospital in which we will sort at random 22 patients to receive mini-implants and 22 to receive conventional implants. We will follow both groups up for 6 months and collect preliminary information on pain, impact on quality of life, ability to chew and costs. This information will tell us how best to measure the costs and effects of dental implants and number of patients we will need in a full trial. The pilot trial will also tell us how quickly we can recruit patients and how many will stay in a trial once they have been recruited. The study will also help us build a team and give pragmatic information on how to effectively manage a large-scale trial.
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