Journal of clinical periodontology
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J. Clin. Periodontol. · May 1995
ReviewA survey of endpoint characteristics in periodontal clinical trials published 1988-1992, and implications for future studies.
Endpoints are conditions or events that are associated with individual study subjects and that are used to assess treatment efficacy. 2 types of endpoints can be distinguished: "true" endpoints (reflect unequivocal evidence of tangible benefit to the patient) and "surrogate" endpoints (usually a measure of disease process). The purpose of this study was to survey four aspects of endpoint usage in randomized controlled trials (RCT's) on the treatment of periodontitis: (1) the typical number of endpoints per RCT, (2) the proportion of RCTs using the same endpoint, (3) the proportion of RCTs using true endpoints, and (4) whether treatment choice influenced endpoint choice. 92 publications (1988-1992) reporting on 82 RCT's were identified. The typical number of endpoints per RCT was 6 (range: 1-28). ⋯ If a need for definitive randomized controlled trials is perceived, then the use of (multiple) surrogate endpoints as primary outcomes should be questioned. Surrogate endpoint usage has led to both false positive and false negative conclusions in other chronic disease studies. Endpoint selection and validation in RCTs may be an important element in resolving controversies about periodontal treatments.
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This investigation was undertaken to determine the intra- and inter-examiner reliability of the method of stimulation for bleeding used in the Eastman interdental bleeding index. 26 subjects were examined twice, 1 h apart, by either a single examiner or 2 examiners in each half of their mouths, for the presence bleeding after stimulation with a wooden interdental cleaner. Scores were tabulated and intra- and inter-examiner % agreements and kappa-coefficients calculated. Z-tests were performed on the pairs of agreement statistics to check for significant differences. ⋯ The overall inter-examiner agreement statistics were good (82.8% to 87.6% agreement; 0.62-0.75 kappa coefficient). When inter-examiner data were analyzed at facial or lingual sites by arch and location, a significant difference existed in reliability for mandibular posterior lingual sites, but reliability was high in all other areas. These data demonstrate a high level of reproducibility for this method, which suggests that the Eastman interdental bleeding index is suitable for clinical trials and epidemiologic studies of interdental gingivitis.
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J. Clin. Periodontol. · May 1983
Comparative StudyEfficacy of paracetamol in reducing post-operative pain after periodontal surgery.
In a double-blind, placebo-controlled study, the efficacy of 2 doses of paracetamol (500 and 1000 mg) was assessed in post-operative pain after periodontal flap surgery. Both doses of paracetamol provided greater analgesia than placebo, however, significant analgesia (P less than 0.05) was only noted in the early post-operative period. The analgesia from both doses of paracetamol did not differ significantly throughout the 3-day observation period, however, greater analgesia was attributable to 1000 mg paracetamol in the immediate post-operative period. The results from this study suggest that paracetamol is an effective analgesic for controlling post-operative pain after periodontal flap surgery, with 1000 mg dose being more effective than 500 mg immediately after surgery.