The McGill consensus statement on overdentures. Mandibular two-implant overdentures as first choice standard of care for edentulous patients.
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Biomedical subjects
Publications and source records attributed to M A Awad.
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Several researchers have suggested that patients' preferences for a particular form of treatment should be taken into account in clinical trials. Preferences may influence the outcome of treatment, especially in trials when patients cannot be blinded to the type of treatment received and the outcome is based on patients' evaluations of therapy. Participants in this study were 136 edentulous patients who took part in a randomised controlled clinical trial comparing two types of treatments for edentulism: conventional dentures and implant-supported prostheses. Prior to receiving treatment, subjects were required to complete a questionnaire regarding their satisfaction with their present prostheses. In addition, they were asked to indicate which treatment they would prefer if given a choice. The objective of this study was to determine whether there are important differences among study participants between patients who have a treatment preference and those who do not. The effects of satisfaction with pre-treatment prostheses, age, gender and level of education on preferences were examined. Level of satisfaction with the original dentures and level of education were significant predictors of preference. Compared to subjects who rated their satisfaction with their current condition as 'low', the odds ratios associated with having a preference for implant treatment were 0.31 (95% CI: 0.09 to 0.96) for subjects who rated their prostheses in the 'medium' range and 0.11 (95% CI: 0.03 to 0.41) for those who rated in the 'high' range. In addition, subjects with high levels of education were significantly less likely to have a preference for either conventional or implant treatments (OR = 0.18, 95% CI: 0.02 to 0.77 and OR = 0.20, 95% CI: 0.05 to 0.76, respectively) compared to those with low education. Neither age nor gender was a significant predictor of preference. We suggest that study designs which incorporate patients' preferences must take into account possible differences between preference groups that might confound the relationship between preference and the outcome of interest.
The importance of assessing the impact of treatments for chronic conditions on an individual's quality of life has been well-established. In this randomized clinical trial, oral-health-related quality of life, measured with the Oral Health Impact Profile (OHIP), was compared between two groups of edentulous patients. One group (n = 54) received mandibular implant-supported overdentures, and the other group (n = 48) received conventional dentures. Assessments were performed pre-treatment and two months after the prostheses were delivered. The multivariate model showed that implant treatment was significantly associated with lower post-treatment OHIP scores (p = 0.0002), indicating a better quality of life. In addition, pretreatment OHIP scores, treatment allocation, age, sex, and marital status explained 31% of the variation in post-treatment OHIP scores (F = 0.0001). These results suggest that implant treatment provides significant short-term improvement over conventional treatment in oral-health-related quality of life.
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Research on several health problems shows that patients and health care providers do not use the same criteria to evaluate the effectiveness of treatment and often disagree on the severity of symptoms. When the disease is chronic and the main aim of treatment is to improve quality of life, we argue that variables rated as important by patients should be used as outcomes in clinical trials, and that in most cases these need to be measured from subjects' self-reports. In many non-pharmacological randomized clinical trials, the subjects cannot be blinded to treatment. Furthermore, many of them will probably have a preference for a particular treatment option. It has been proposed that emotional responses following assignment of treatments, which may or may not be preferred, will strongly influence the outcome, especially when it is based on self-reports of treatment satisfaction. Because of this concern, some investigators have suggested alternative study designs that incorporate preference. Brewin & Bradley (Br Med J 1989; 299 [6694]:313-5) have proposed allocating subjects to treatment methods according to their preferences, and randomizing those individuals with no preference. To determine the influence of preference on treatment outcome, they recommend comparing results from the preference group with those of the randomized group. However, we have found that there are clear differences in level of education and in the pre-treatment state between individuals with preferences and those with no strong preferences. Therefore, we believe that the design proposed by Wennberg et al. (Ann N Y Acad Sci 1993;703:52-62) is more appropriate. In it, subjects are randomly allocated to a preference trial (subjects choose their treatment) or to a randomized trial (random allocation to treatment). Between-trial comparisons can then be used to determine the influence of preference on outcome. This will lead to better evaluation of treatment efficacy and allow better estimates of the true effectiveness to be made.
OBJECTIVES: Previous research has shown that patients' evaluations of their prostheses correlate poorly with the clinicians' assessments, as well as with intraoral anatomic factors. It has been recommended that researchers conduct more studies that use patient satisfaction as the primary outcome measure in treatment evaluation and that more attention be paid to understanding exactly what measures of patient satisfaction represent. In this study, the relationship between patients' ratings of general satisfaction and their perceptions of different aspects of mandibular prostheses is investigated. METHODS: One hundred and twenty subjects applied to participate in a randomized controlled clinical trial comparing two types of mandibular prostheses: conventional dentures and implant prostheses. At baseline, they were asked to rate on 100 mm visual analog scales (VAS) factors that edentulous patients indicated were important to them. These included comfort, ability to chew, stability, esthetics, ability to speak and ease of cleaning of their conventional dentures. Subjects were also asked to rate their general satisfaction with their dentures. In addition, they selected the one quality of their denture that they considered to be most important. RESULTS: Multiple regression methods revealed that gender, as well as patients' ratings of comfort, stability, esthetics, ability to chew and ability to speak with their prostheses contributed significantly to general satisfaction (F<0.0001). Furthermore, 89% of the variation in ratings of general satisfaction was explained by these factors. In addition, patients who considered ability to chew as the most important factor associated with their dentures rated their general satisfaction significantly higher than the other subjects (P=0.0003). CONCLUSION: Patient satisfaction with conventional dental prostheses is highly dependent on gender, and the appearance and functionality of the appliance. The combined effect of these factors explained most of the variation in the satisfaction ratings.
One hundred and sixty children who had lived from birth in a region with low fluoride levels in the drinking water, and who had been offered sodium fluoride supplementation in the form of drops for daily use, were examined to evaluate dental caries and dental fluorosis. Two age ranges were selected: 7-9 years and 11-14 years. In addition to the dental examinations, questionnaires were mailed to the parents, followed-up by telephone interviews, to gather information on compliance with the fluoride supplementation program. The results showed no statistically significant differences in dental caries activity between the regular and irregular users of fluoride supplementation. Considerable dental fluorosis was found in both regular and irregular user groups of the fluoride supplement (38 to 63 per cent of the children seen), however, with no statistical difference between the user groups. Most of the fluorosis detected was of a mild degree. Fluoride supplementation under the daily control of a parent or child is not recommended because of the difficulty in maintaining regular compliance and the risk of fluorosis.
Aortic onchocercosis due to O. armillata was diagnosed in 45 (41%) out of 109 Sudanese camels. Although the thoracic aorta was regularly affected, involvement of other vessels such as the abdominal aorta, brachiocephalic, pulmonary and costocervical arteries was not excluded. Gross examination of the affected blood vessels revealed tortuous tunnels of parasitic tracks readily visible in the intimal surface of the vessels. Nodular lesions were more common on the adventitia. Microscopically, the lesions showed irregulary elevated intimal surfaces. The underlying tunica media contained a varying number of encapsulated and partially mineralized parasitic fragments. The inflammatory response varied in intensity and location and consisted of eosinophils, lymphocytes, macrophages and occasional giant cells.
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