Total 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. Forty-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. The 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. The 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. (ISRCTN): 87342238 Trial registration date: 05/07/2013.
A convenience sample of 154 edentulous patients referred for implant provision at a Regional National Health Service Dental Hospital in the North West of England were identified. The cephalometric radiographs that were taken as part of the patient baseline investigation were assessed. Digital tracing was used to measure the anterior maxillary and mandibular bone height and ridge angle with respect to the maxillary and mandibular planes. The mean height of the bone in the maxilla was found to be 14 mm, and the mean ridge angle for the anterior maxillary residual ridge is 104°. The mean height of bone in the mandible was 18 mm, while the mean ridge angle for the anterior mandibular residual ridge was 77°. Using the Cawood and Howell classification demonstrated that class VI mandibles were the most common. The cross-sectional shape of the mandible varied, with the triangular shape most common. Although there was adequate bone stock for implant placement in these cases, the mandibular residual ridge resorption presents a lingual inclination to the residual bone. The limited residual ridge position and inclination would dictate that conventional implant placement could be challenging.
The rotational movement of mini dental implants (MDIs) overdenture disturbs the function of the prosthesis. Many dentists place more MDIs to improve the overdenture stability; however, the influence of the MDIs number and distribution on the overdenture resistance to para-axial dislodgment has not been investigated. Seven resin models simulating atrophic mandibles housed twenty MDIs placed according to seven arrangements. Acrylic overdentures were fabricated for each cast and were dislodged five times in lateral, anterior and posterior directions, and the peak load dislodgment was measured. Each overdenture underwent 540 axial removal/placement cycles. The para-axial dislodgments were measured again, and data were compared. Dislodgment force values were measured in all directions, and the data were analysed using analysis of variance ANOVA and post hoc (p < 0.05). After six months of simulated placement/removal, increasing the MDI number showed a difference in resistance to para-axial dislodgment. The distribution affected the resistance to dislodgment in some directions. The inter-implant distance of 27 mm provided better resistance to posterior dislodgment than placing two MDIs close together at 19 mm. The placement of three MDIs at any distribution showed no significant difference except for resistance to posterior dislodgment. FourMDIs placed at any distribution showed a significant difference in all groups in all tested directions. The resistance to the para-axial dislodgment of MDI overdenture could improve with the increasing MDIs number and careful planning of MDI distribution.
4 October 2006 in Journal of Biomedical Materials Research Part B: Applied Biomaterials