Abstract
BackgroundTotal tooth loss (edentulism) can be a debilitating condition, impacting on ability to chew, speak and interact with others. The most common treatment is with complete removable dentures, which may be successful, but in the lower jaw, bone resorption that worsens over time makes denture-wearing difficult. Two dental implants in the mandible to retain the lower denture has been advocated as the gold standard of treatment, but has not been universally provided due largely to financial constraints and also patient fear. Mini implants (MI) are cheaper and less invasive than conventional implants (CI), but may not have equivalent longevity. Therefore, it is unknown whether they represent a cost-effective treatment modality over time. The aim of this pilot randomised controlled trial was to assess the feasibility of carrying out a trial on this cohort of patients, and to inform the study design of a large multicentre trial.MethodsForty-six patients were randomly allocated to receive either two mini implants or two conventional implants in the mandible to retain their lower dentures. Quality of life (QoL) questionnaires, pain and anxiety scores, and an objective “gummy jelly” chewing test were carried out at multiple timepoints, along with detailed health economics information. Implants were placed one-stage, and an early loading protocol was utilised. Patients were reviewed 8 weeks post-placement, and finally at 6 months. Implant failure, recruitment and retention rates were recorded and analysed.ResultsThe pilot study demonstrated that it is possible to recruit, randomise and retain edentulous (mainly elderly) patients for an implant trial. We recruited to target and retention rates were acceptable. The large number of questionnaires was onerous for participants to complete, but the distribution of scores and feedback from participants helped inform the choice of primary and secondary outcomes in a full trial. The chewing test was time-consuming and inconsistent. Implant failure rate was low (1/46). The data on indirect costs gathered at every visit was viewed as repetitive and unnecessary, as there was little or no change between visits.ConclusionsThe pilot study has shown that acceptable recruitment and retention rates are achievable in this population of patients for this intervention. The results provide valuable information for selection of outcome variables and sample size calculations for future trials.Trial registration(ISRCTN): 87342238 Trial registration date: 05/07/2013.
Highlights
Total tooth loss can be a debilitating condition, impacting on ability to chew, speak and interact with others
Only four patients who were dissatisfied with their new denture did not want to be randomised, having a preference for mini-implants or conventional implants
The initial plan was to recruit a maximum of 44 participants or as many participants as possible in the planned 1-year recruitment period, in total 46 patients were recruited and randomised
Summary
Total tooth loss (edentulism) can be a debilitating condition, impacting on ability to chew, speak and interact with others. The majority of edentulous patients are able to chew their food with complete dentures but over time, the lower jaw becomes resorbed and there is less bone to retain the lower denture This makes it more difficult to retain the denture which causes problems for the denturewearer, such as difficulties in eating and speaking, which may lead to a change in lifestyle, as those affected become embarrassed to socialise and eat with friends [3]. Their inability to chew results in poorer food choices [4, 5] with many opting for highly calorific softer foods that are easier to eat. All of these factors have been shown to impact greatly on a patient’s quality of life [6]
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