Background: Total tooth loss (edentulism) can be a debilitating condition, impacting on ability to chew, speak and\ninteract with others. The most common treatment is with complete removable dentures, which may be successful,\nbut in the lower jaw, bone resorption that worsens over time makes denture-wearing difficult. Two dental implants\nin the mandible to retain the lower denture has been advocated as the gold standard of treatment, but has not\nbeen universally provided due largely to financial constraints and also patient fear. Mini implants (MI) are cheaper\nand less invasive than conventional implants (CI), but may not have equivalent longevity. Therefore, it is unknown\nwhether they represent a cost-effective treatment modality over time. The aim of this pilot randomised controlled\ntrial was to assess the feasibility of carrying out a trial on this cohort of patients, and to inform the study design of\na large multicentre trial.\nMethods: Forty-six patients were randomly allocated to receive either two mini implants or two conventional\nimplants in the mandible to retain their lower dentures. Quality of life (QoL) questionnaires, pain and anxiety scores,\nand an objective ââ?¬Å?gummy jellyââ?¬Â chewing test were carried out at multiple timepoints, along with detailed health\neconomics information. Implants were placed one-stage, and an early loading protocol was utilised. Patients were\nreviewed 8 weeks post-placement, and finally at 6 months. Implant failure, recruitment and retention rates were\nrecorded and analysed.\nResults: The pilot study demonstrated that it is possible to recruit, randomise and retain edentulous (mainly elderly)\npatients for an implant trial. We recruited to target and retention rates were acceptable. The large number of\nquestionnaires was onerous for participants to complete, but the distribution of scores and feedback from participants\nhelped inform the choice of primary and secondary outcomes in a full trial. The chewing test was time-consuming and\ninconsistent. Implant failure rate was low (1/46). The data on indirect costs gathered at every visit was viewed as\nrepetitive and unnecessary, as there was little or no change between visits.\nConclusions: The pilot study has shown that acceptable recruitment and retention rates are achievable in this population\nof patients for this intervention. The results provide valuable information for selection of outcome variables and sample size\ncalculations for future trials.
Loading....