科研之友
微信
新浪微博
Facebook
分享链接
摘要
Subjects This study is a 2- to 4-year post-trial follow-up of a 3-year randomized clinical trial (RCT). In the original trial, between March 2005 and February 2006, 22 general dental practices in New South Wales and the Australian Capital Territory (Australia) were recruited and randomized: 12 to the intervention arm and 10 to the control arm. Practices represented city, suburban, and rural practices in both fluoridated and nonfluoridated communities. Immediately after randomization, 3 practices withdrew, leaving 10 practices enrolled in the intervention group (involving 452 recruited subjects) and 9 in the control group (involving 450 recruited subjects), which were followed up for 2 years. At each practice, typically the first 50 consecutive patients who consented to participate were enrolled. Subjects' age ranged between 45 and 89 years, with significantly different sex distribution among the 2 study groups (39% and 53% male in the intervention and control groups, respectively). At the end of the initial RCT period, all practices were still participating, with 411 patients in the intervention group (41 lost to follow-up) and 400 patients in the control group (50 lost to follow-up). To be followed up in the post-trial period, a practice needed to continue using the study protocols and retain the calibrated study dentist. If protocols were discontinued, there was a loss of interest, or dentists changed/sold the practice, then the practice was dropped during the follow-up analyses. At year 5 (2 years after trial), the numbers of practices followed up were 4 in the intervention group (63 patients followed) and 8 in the control group (239 patients followed). At year 7 (4 years after trial), the numbers of practices followed up were 4 in the intervention group (52 patients followed) and 7 in the control group (162 patients followed). Thus, 8 practices were lost to follow-up after the trial; however, the baseline mean decayed-missing-filled teeth (DMFT) balance was maintained between the 2 study groups. Key Exposure/Study Factor Practices in the intervention group were trained in the Caries Management System (CMS), which was then used to manage dental caries in subjects enrolled in these practices. The guiding philosophy behind the CMS protocols was that caries lesions can be prevented and noncavitated lesions can be arrested, remineralized, and monitored and should not be restored. The CMS framework comprised a set of protocols covering caries diagnosis, risk assessment, and risk-based management, monitoring, and recall. Risk was determined based on caries experience (ie, high-risk subjects presented with cavities or over time they developed more than 1 new caries lesion/y; medium-risk subjects presented with teeth exhibiting initial enamel breakdown [International Caries Detection and Assessment Criteria (ICDAS), code 3] or interproximal radiographic lesions confined to the outer third of dentin or over time they developed 1 new lesion within a year or progression of existing lesions; and low-risk subjects presented with either radiolucencies of lesser depth or no more than noncavitated lesions [ICDAS stage 2]). Management was based on modifying the patient's behavior (ie, oral hygiene coaching, selection of healthy diet, and restriction of between-meal exposures to sugar-containing meals and beverages). The nonsurgical clinical care involved fluoride varnish applications (ie, every 3 months for high-risk patients and every 6 months for medium-risk subjects) and sealants for preventive and therapeutic purposes. Main Outcome Measure The CMS protocols were designed to prevent caries incidence and arrest noncavitated caries lesions, thus preventing their progression and need for restorative care. In the initial RCT, caries risk reduction was monitored as a change (visual and radiographic) in lesion incidence and progression. Both patient- and practice-level DMFT increments (ie, cumulative increment in DMFT at the patient level and practice mean and median increments of patient DMFT at the practice level) were used 2 to 4 years after the trial to assess the reduction of caries risk and need for restorative intervention. During the initial RCT, the D (decay) component of the DMFT index was extracted by study team members from periodic monitoring of clinical charts and radiographs. However, monitoring visits ended at year 3; thus, at the 2 and 4-year post-trial points, the D component of the index could not be reported. Thus, the study team decided to assume that any replacement fillings and new fillings in the post-trial period were done due to decay, and therefore, the D increment would be manifested in the F (filling) component of the index. Therefore, DMFT was estimated as M + F during years 4 through 7. Main Results With respect to patient-level DMFT increments, at 2 years after the trial (year 5 of the study), there were no significant differences in the mean DMFT increments for the intervention and control groups (ie, 1.21 and 1.53, respectively). During years 6 and 7 (the second 2-year post-trial period), the intervention group had a significantly (P < .05) smaller DMFT increment than the control group (1.23 vs 1.80, respectively). In addition, over the 4-year post-trial period (years 4 to 7), the intervention group had a significantly smaller DMFT increment (28% difference) than the control group (2.44 vs 3.39, respectively). Overall, from the start of the trial until the end of the post-trial period (year 7), the CMS protocol group had a significantly smaller DMFT increment (29% smaller) than the control group (6.13 vs 8.66, respectively). Considering the practice-level DMFT increments, the practice mean differences in DMFT increments were only significantly different during the post-trial period over the 7 year period, with CMS practices having significantly smaller mean increments (33%) compared with controls (4.38 vs 6.55, respectively). The practice median differences in DMFT increments were significantly different during both the 4-year post-trial period (1.25 in the intervention vs 2.36 in the control, 47% difference) and the period between baseline and year 7 (2.87 in the intervention vs 5.36 in the control, a 47% difference). There were minimally elevated odds of being at high risk for caries (odds ratio: 1.17) associated with baseline DMFT. The odds of being at high risk were lower in the CMS group than those in the control practices (odds ratio: 0.23; 95% confidence interval: 0.06-0.88). Neither age on enrollment nor current exposure to fluoridated water was significantly associated with reduced risk. Conclusion The authors concluded that in practices that adhered to the CMS protocols during the 4-year post-trial follow-up period, patients experienced lower needs for restorative treatment.
- 出版日期2016-12
