Trial Status: Closed to recruitment - in follow up
This multi-centre, collaborative research team has been investigating the 3-D printing of dentures. There is the potential for 3-D printed dentures to fit more accurately and be cheaper to manufacture.
Following on from our preliminary study (which improved the clinical and technical workflow for 3-D printed dentures) we now wish to run a pilot RCT. The purpose of this pilot Randomised Controlled Clinical Trial (RCT) is to undertake a study which will enable us to calculate the number of participants needed for a full scale RCT. To do this we will run this pilot RCT to the full protocol proposed for the future comprehensive RCT.
In two previous RCTs of dentures, this research team successfully used the published ÒIMPROVDENTÓ protocol to investigate potential improvements to conventional dentures. We propose to use that established protocol for this study. For this pilot RCT we will produce 2 sets of dentures for each participant, one made to the gold standard traditional method and one made by 3-D printing. We will then use a series of patient-centred outcome measures to determine which denture is best. The primary outcome measure for this pilot RCT is the patient preference for the dentures. The associated research question is: which dentures, conventional or 3-D printed, do the participants prefer? The secondary outcome measures seek to address issues of comfort, stability, use, and aesthetics of the dentures.
Participants with no natural teeth, who require new dentures, will be eligible at the three participating University Dental Hospital sites. The protocol allows 5 visits, 2-3 weeks apart, to construct the two sets of dentures followed by 4 visits over the following 20 weeks to assess the dentures. At the participantÕs request, further follow-up visits may be included (as needed). The research is funded by Dunhill Medical Trust.