Impact of Replacing Fentanyl With Hydromorphone as the First-Line Postoperative Opioid Among Patients Undergoing Outpatient Cancer Surgery.

PURPOSE: In response to a nationwide fentanyl shortage, our institution assessed whether changing our first-line postoperative intravenous opioid from fentanyl to hydromorphone impacted patient outcomes. The primary research aim was to evaluate the association between first-line opioid and rapidity of recovery. DESIGN: The study team retrospectively obtained data on all consecutive patients extracted from the electronic medical record. The rapidity of recovery was defined as the time from entry into the postanesthesia care unit to the transition to Phase 2 for ambulatory extended recovery patients and as the length of total postanesthesia care unit stay for outpatients. METHODS: Following intent-to-treat-principles, we tested the association between study period and rapidity of recovery (a priori clinically meaningful difference: 20 minutes) using multivariable linear regression, adjusting for anesthesia type (general vs monitored anesthesia care), American Society of Anesthesiologst physical status (ASA) score (1-2 vs 3-4), age, service, robotic procedure, and surgery start time. FINDINGS: Ambulatory extended recovery patients treated in the hydromorphone period had, on average, a 0.25 minute (95% confidence interval [CI] -6.5, 7.0), nonstatistically significant (P > .9) longer time to transition. For outpatient procedures, those who received hydromorphone had, on average, 8.5-minute longer stays (95% CI 3.7-13, P < .001). Although we saw statistical evidence of an increased risk of resurgery associated with receiving hydromorphone (0.5%; 95% CI -0.1%, 1.0%; P = .039 on univariate analysis), the size of the estimate is clinically and biologically implausible and is most likely a chance finding related either to multiple testing or confounding. CONCLUSIONS: The multidisciplinary team concluded that the increase in postoperative length of stay associated with hydromorphone was not clinically significant and the decrease waste of prefilled syringes outweighed the small potential increased risk of resurgery compared to the shorter-acting fentanyl. We will therefore use hydromorphone moving forward.

Postmenopausal women with HIV have increased tooth loss.

BACKGROUND: With effective antiretroviral therapy, people with HIV (PWH) are living longer and aging; the majority of PWH in the United States are now over the age of 50 and in women have gone through the menopause transition. Menopause potentiates skeletal bone loss at the spine, hip, and radius in PWH. The alveolar bone which surronds the teeth is different than long bones because it is derived from the neural crest. However, few studies have assessed the oral health and alveolar bone in middle aged and older women with HIV. Therefore, the objective of this study was to evaluate periodontal disease and alveolar bone microarchitecture in postmenopausal women with HIV. METHODS: 135 self-reported postmenopausal women were recruited (59 HIV-, 76 HIV + on combination antiretroviral therapy with virological suppression) from a single academic center. The following parameters were measured: cytokine levels (IFN-γ, TNF-α, IL-1ß, IL-2, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12p70, IL-13, IL-17 A, OPG, and RANKL) in gingival crevicular fluid, bleeding on probing, probing depth, clinical attachment loss, number of teeth present, alveolar crestal height, and alveolar bone microarchitecture. RESULTS: The mean age of participants was 57.04+/-6.25 years and a greater proportion of women with HIV were black/African American (HIV + 68.42%, HIV- 23.73%; p < 0.001). There was no significant difference in bleeding on probing (p = 0.17) and attachment loss (p = 0.39) between women who were HIV infected vs. HIV uninfected. Women with HIV had significantly higher RANKL expression in Gingival Crevicular Fluid (HIV + 3.80+/-3.19 pg/ul, HIV- 1.29+/-2.14 pg/ul ; p < 0.001), fewer teeth present (HIV + 17.75+/-7.62, HIV- 22.79+/-5.70; p < 0.001), ), lower trabecular number (HIV + 0.08+/-0.01, HIV- 0.09+/-0.02; p = 0.004) and greater trabecular separation (HIV + 9.23+/-3.11, HIV- 7.99+/-3.23; p = 0.04) compared to women without HIV that remained significant in multivariate logistic regression analysis in a sub-cohort after adjusting for age, race/ethnicity, smoking status, and diabetes. CONCLUSION: Postmenopausal women with HIV have deterioration of the alveolar trabecular bone microarchitecture that may contribute to greater tooth loss.

How to Evaluate Clinical Trials in Contemporary Dental Journals.

Knowing how to rightly interpret studies is important for dental clinicians so they can glean pertinent information that can be applied to patient care. This article describes the contents that are included in the introduction, methods and materials, results, and discussion sections of a clinical trial and emphasizes several important statistical concepts, including why a statistically significant difference does not necessarily translate to a clinically significant finding. The authors conclude that critical analyzation of a clinical trial enhances evidence-based clinical practice.

The utility of a formative one-station objective structured clinical examination for Substance use disorders in a dental curriculum.

Substance use disorders (SUD) are chronic relapsing medical conditions characterised by compulsive substance seeking and use. They constitute a substantial disease burden globally. Labelling of persons with SUD has created barriers to treatment but there are effective management strategies. The dental profession has embraced reforms designed to address the SUD epidemic by promoting continuing education for practitioners and initiating curriculum changes in dental schools. Screening, Brief Intervention and Referral to Treatment (SBIRT) is an evidence-based model for managing patients with SUD. The use of a formative 1-station Objective Structured Clinical Examination (OSCE) for learning and assessment in SBIRT, operationalised with the MD3 rating scale is presented in this study. In 3 years of implementation, the SBIRT OSCE successfully integrated into the curriculum of the College of Dental Medicine, Columbia University. Mean score of total adherent behaviours was 11.80 (SD =4.23) (range: 2 - 24) and Cronbach's coefficient alpha for across-items reliability in adherent behaviours was 0.66. Adherent behaviours correlated with the global ratings (r = 0.66). Mean of global rating scores were 2.90 (SD =1.01) for collaboration and 2.97 (SD =1.00) for empathy and the global rating scores correlated with each other (r = 0.85). Histograms of global rating scores resembled normal distribution. The 1-station OSCE is a good model for learning about SBIRT. Psychometric analysis was useful in understanding the underlying construct of the MD3 rating scale and supported its reliability, validity and utility in dental education.

Innovations in pre-doctoral dental education: Influencing attitudes and opinions about patients with substance use disorder.

Screening, Brief Intervention, and Referral to Treatment (SBIRT) is an evidence-based model for managing patients with substance use disorders (SUD). Historically, SUD were seen as a criminal issue and access to treatment was limited, but that paradigm is shifting and substance abuse is now being recognized as a disease state and the management of patients with SUD is increasingly within the healthcare system starting with primary healthcare settings including dental facilities. In a new training initiative, first-year dental students (DDS1) attended a 90-minute SBIRT training. An Attitudes and Opinion Survey (AOS) consisting of 8 questions that separately assesses DDS1 attitudes toward alcohol and drug use disorders was utilized to evaluate the training. Assenting DDS1 anonymously completed the AOS before and following the training. Over 3 years, we analyzed changes in the AOS of 230 DDS1 using Chi-squared test for bivariate comparison. We then applied a Bonferroni correction to the P-values. Response rate was 95.5%. The SBIRT training improved DDS1 attitudes and opinions toward patients with SUD with respect to all AOS questions. There was a statistically significant improvement (P < 0.003) in DDS1 attitudes and opinions with respect to whether other patients care suffers because of time and resources spent on patients with SUD and whether the SBIRT training provided adequate education to prepare DDS1 to manage patients with SUD. SBIRT training is relevant to dental education. It fills an important educational gap and is a suitable model for other dental schools.

Completeness of Electronic Dental Records in a Student Clinic: Retrospective Analysis.

BACKGROUND: A well-designed, adequately documented, and properly maintained patient record is an important tool for quality assurance and care continuity. Good clinical documentation skills are supposed to be a fundamental part of dental student training. OBJECTIVE: The goal of this study was to assess the completeness of electronic patient records in a student clinic. METHODS: Completeness of patient records was assessed using comparative review of validated cases of alveolar osteitis treated between August 2011 and May 2017 in a student clinic at Columbia University College of Dental Medicine, New York, USA. Based on a literature review, population-based prevalence of nine most frequently mentioned symptoms, signs, and treatment procedures of alveolar osteitis was identified. Completeness of alveolar osteitis records was assessed by comparison of population-based prevalence and frequency of corresponding items in the student documentation. To obtain all alveolar osteitis cases, we ran a query on the electronic dental record, which included all cases with diagnostic code Z1820 or any variation of the phrases "dry socket" and "alveolar osteitis" in the notes. The resulting records were manually reviewed to definitively confirm alveolar osteitis and to extract all index items. RESULTS: Overall, 296 definitive cases of alveolar osteitis were identified. Only 22% (64/296) of cases contained a diagnostic code. Comparison of the frequency of the nine index categories in the validated alveolar osteitis cases between the student clinic and the population showed the following results: severe pain: 94% (279/296) vs 100% (430/430); bare bone/missing blood clot: 27% (80/296) vs 74% (35/47) to 100% (329/329); malodor: 7% (22/296) vs 33%-50% (18/54); radiating pain to the ear: 8% (24/296) vs 56% (30/54); lymphadenopathy: 1% (3/296) vs 9% (5/54); inflammation: 14% (42/296) vs 50% (27/54); debris: 12% (36/296) vs 87% (47/54); alveolar osteitis site noted: 96% (283/296) vs 100% (430/430; accepted documentation requirement); and anesthesia during debridement: 77% (20/24) vs 100% (430/430; standard of anesthetization prior to debridement). CONCLUSIONS: There was a significant discrepancy between the index category frequency in alveolar osteitis cases documented by dental students and in the population (reported in peer-reviewed literature). More attention to clinical documentation skills is warranted in dental student training.

Invasive Oral Procedures and Events in Postmenopausal Women With Osteoporosis Treated With Denosumab for Up to 10 Years.

CONTEXT: Antiresorptive therapy has been associated with osteonecrosis of the jaw (ONJ), an infrequent but potentially serious adverse event. OBJECTIVE: To assess information on invasive oral procedures and events (OPEs)-dental implants, tooth extraction, natural tooth loss, scaling/root planing, and jaw surgery-during the 7-year Fracture REduction Evaluation of Denosumab in Osteoporosis every 6 Months (FREEDOM) Extension study and to present details of positively adjudicated ONJ cases. DESIGN: Randomized, double-blind, placebo-controlled, 3-year trial (FREEDOM) followed by 7 years of open-label denosumab (FREEDOM Extension). At Extension Year 3, women were asked to record their history of invasive OPEs since the start of the Extension to Year 2.5 and oral events in the prior 6 months. The questionnaire was then administered every 6 months until the end of the Extension. SETTING: Multicenter, multinational clinical trial. PATIENTS: Postmenopausal women with osteoporosis. INTERVENTIONS: Subcutaneous denosumab 60 mg or placebo every 6 months for 3 years, then 7 years of open-label denosumab. MAIN OUTCOME MEASURES: Self-reports of OPEs and adjudicated cases of ONJ. RESULTS: Of respondents, 45.1% reported at least one invasive OPE. The exposure-adjusted ONJ rate in FREEDOM Extension was 5.2 per 10,000 person-years. ONJ incidence was higher in those reporting an OPE (0.68%) than not (0.05%). CONCLUSIONS: Although invasive OPEs were common in these denosumab-treated women and were associated with an increased ONJ incidence, the overall rate of ONJ was low, and all cases with complete follow-up resolved with treatment.

Relationship Between Dental Students' Pre-Admission Record and Performance on the Comprehensive Basic Science Examination.

The Comprehensive Basic Science Examination (CBSE) is the entrance examination for oral and maxillofacial surgery, but its implementation among dental students is a relatively recent and unintended use. The aim of this study was to examine the relationship between pre-admission data and performance on the CBSE for dental students at the Columbia University College of Dental Medicine (CDM). This study followed a retrospective cohort, examining data for the CDM Classes of 2014-19. Data collected were Dental Admission Test (DAT) and CBSE scores and undergraduate GPAs for 49 CDM students who took the CBSE from September 2013 to July 2016. The results showed that the full regression model did not demonstrate significant predictive capability (F[8,40]=1.70, p=0.13). Following stepwise regression, only the DAT Perceptual Ability score remained in the final model (F[1,47]=7.97, p<0.01). Variations in DAT Perceptual Ability scores explained 15% of the variability in CBSE scores (R2=0.15). This study found that, among these students, pre-admission data were poor predictors of CBSE performance.

Periodontitis and bone metabolism in patients with advanced heart failure and after heart transplantation.

AIMS: Heart failure (HF) is a multi-organ, pro-inflammatory syndrome that impairs bone metabolism. Pro-inflammatory cytokines and bone catabolism enhance periodontal disease, a local inflammatory, bacteria-induced disease that causes bone loss and periodontal soft tissue destruction. METHODS AND RESULTS: Medical and dental examinations were performed on patients with HF (n = 39), following heart transplantation (post-HTx, n = 38) and controls (n = 32). Blood, saliva, and gingival crevicular fluid were analysed for bone metabolism and inflammation markers. HF average New York Heart Association classification was III. Average time since HTx was 1414 days. Pro-inflammatory tumour necrosis factor-alpha was higher in HF and HTx as compared with controls (P < 0.05). Both HF and HTx participants had higher levels of bone resorption marker C-terminal telopeptide and parathyroid hormone with subjects in the HF group having the highest serum levels of all groups (P ≤ 0.05). In contrast, 25-hydroxyvitamin D was lowest in HF. HF patients had greater clinical attachment loss, cumulative pockets depth (greater than 3 mm) and probing depth (P < 0.05) as compared with controls. Cumulative pockets depth correlated significantly with measures of the inflammatory burden, ß-glucuronidase in saliva (r = 0.4863, P < 0.01), interleukin-1b in saliva (r = 0.5149, P < 0.01), and gingival crevicular fluid (r = 0.6056, P < 0.001) in HF. However, adjustment of periodontal results for measures of oral hygiene (plaque, bleeding on probing), systemic 25-hydroxyvitamin D, and race attenuated significant differences between groups. CONCLUSIONS: Patients with HF exhibit more severe periodontal disease associated with increased bone turnover markers when compared with control patients. However, local and systemic factors may account for this association and should be evaluated in future studies.

Origin of galactose-deficient immunoglobulin g in gingival crevicular fluid in periodontitis.

BACKGROUND: Periodontitis is a chronic inflammatory disease initiated by a synergistic and dysbiotic microbial community that elicits a gingival inflammatory response leading to tissue breakdown. Periodontitis shares many characteristics with other chronic inflammatory diseases, including abnormal glycosylation of immunoglobulin (Ig)G. The current authors have previously demonstrated that IgG from gingival crevicular fluid (GCF) of patients with chronic periodontitis contains galactose (Gal)-deficient IgG. METHODS: The origin of the aberrantly glycosylated IgG was determined by measuring levels of Gal-deficient IgG in GCF and serum from patients with periodontitis and non-periodontitis controls using lectin enzyme-linked immunosorbent assay. The Ig-producing cells and the proportion of cells producing Gal-deficient IgG were immunohistochemically determined in gingival tissues from patients with periodontitis by fluorescence microscopy. The results were statistically evaluated and correlated with clinical data. RESULTS: The results indicate that GCF of patients with periodontitis had higher levels of Gal-deficient IgG compared with controls (P = 0.002). In gingival tissues, IgG was the dominant isotype among Ig-producing cells, and 60% of IgG-positive cells produced Gal-deficient IgG. Moreover, the proportion of Gal-deficient IgG-producing cells directly correlated with clinical parameters of probing depth and clinical attachment loss (AL). CONCLUSION: These results suggest that the presence of Gal-deficient IgG is associated with gingival inflammation and may play a role in the worsening of clinical parameters of periodontitis, such as AL.

A novel treatment of gingival recession using a botanical topical gingival patch and mouthrinse.

BACKGROUND AND AIM: Current treatment of gingival recession (GR) is limited to surgical procedures. We describe a case series of 18 patients with GR who were treated with a botanical patch and rinse following standard conservative therapy. CASE SERIES DESCRIPTION: A total of 22 sites with GR > 1 mm were studied. Following scaling and root planing (SRP) and oral hygiene instruction, patients received two courses of patch treatment (3 days each) and botanical rinse administered twice daily throughout the treatment period. Outcome measures (GR, gingival index (GI) and gingival thickness (GT) were taken at baseline; at 1 to 2 weeks; 2 to 4 weeks; and at 6 to 8 weeks. Miller classifcation and plaque index (PI) were measured at baseline and at 6 to 8 weeks. At the end of the treatment period, mean GR decreased from 4.18 ± 1.74 mm to 3.31 ± 1.51 mm (20.8%); Miller grade from 1.86 ± 0.56 to 1.06 ± 0.43; GI scores from 1.45 ± 0.63 to 0.17 ± 0.38 (88.3%); and PI scores from 1.33 ± 0.59 to 0.78 ± 0.94. GT increased from 0.74 mm ± 0.40 to 1.21 ± 0.39 (63.5%). No adverse effects were reported with either the patch or rinse treatments. CONCLUSION: We observed a decrease in GR and GI scores in 18 patients (22 sites) treated with the study patch and rinse, with increased GT. CLINICAL SIGNIFICANCE: A combined botanical patch-rinse treatment may be effective as adjuvant treatment to standard conservative care for GR. Further research is needed to verify these fndings.

Effect of an herbal mouth rinse in preventing periodontal inflammation in an experimental gingivitis model: a pilot study.

BACKGROUND: Gingivitis is a chronic inflammatory condition, resulting from gingival bacteria and bacterial byproducts. Antiplaque oral rinses reduce inflammation by removing or inhibiting plaque formation. The purpose of this pilot study was to examine the anti-inflammatory effects of HM-302, a mouth rinse based on natural products, on gingival inflammation. METHODS: A prospective, double-blinded, randomized parallel-group controlled trial involving 62 patients was conducted to assess efficacy and safety. During a 2-week period with no dental hygiene, subjects were randomized to receive either the study rinse (HM-302); a cetylpyridinium chloride (CPC) rinse; an essential oils (EO) rinse; or a water-only preparation. The gingival index (GI), plaque index (PI), and number of bleeding sites were measured at baseline and at the end of the study period. RESULTS: Progression of gingival inflammation resulting from lack of dental hygiene was lowest in patients treated with the HM-302 rinse, and was significantly less marked than in patients treated with the water-only preparation. When compared to the CPC and EO treatments, HM-302 was the only mouth rinse that was significantlybetter than the control, with respect to both the change in absolute GI scores (p = .006) and to the percent increase in GI scores (p = .012). No serious adverse effects were noted in any of the study groups. CONCLUSION: HM-302 is a safe and effective treatment for preventing the development of gingival inflammation in an experimental gingivitis model. Further research is needed to evaluate its long-term effects.

A phase II trial of a transmucosal herbal patch for the treatment of gingivitis.

BACKGROUND: Systemic treatments for gingivitis frequently are inadequate for controlling specific sites of severe gingival inflammation. The authors conducted a study to test site-specific therapy using a transmucosal herbal periodontal patch (THPP) that was impregnated with plant extracts reported to reduce inflammatory response. METHODS: The study was a single-center, randomized, placebo-controlled, double-masked, longitudinal phase II trial involving participants with clinically diagnosed gingivitis. Participants who were enrolled in the study received either THPPs or placebo patches (PP) for three days. The authors evaluated gingival inflammation visually using the gingival index (GI) and by measuring gingival crevicular fluid ß-glucuronidase (BG) enzymatic activity at baseline (day one) and on days two, four, eight and 15. RESULTS: The authors randomly assigned 53 participants to receive the THPP or the PP. Participants who received the THPPs had a greater reduction in mean GI scores than did those who received the PPs. This finding was significant on days four and 15. The percentage of participants whose GI scores decreased by one or more was higher among those receiving the THPP than among those receiving the PP, as assessed on days four and 15. The average decrease in BG levels (fluorescence units) for participants receiving the THPP was significantly greater on days four and eight than they were for those receiving the PP. No serious adverse events were associated with the use of the THPP. CONCLUSIONS: Topical treatment by means of the THPP may be effective and safe in reducing topical gingival inflammation. Further studies are needed to confirm these findings and determine the best method for administering the THPP and the appropriate dosing. CLINICAL IMPLICATIONS: Site-specific treatment of gingival inflammation is feasible and could be used as an adjunct for systemic therapeutic interventions.

The incidence of osteonecrosis of the jaw in patients receiving 5 milligrams of zoledronic acid: data from the health outcomes and reduced incidence with zoledronic acid once yearly clinical trials program.

BACKGROUND: The Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly-Pivotal Fracture Trial found one case of osteonecrosis of the jaw (ONJ) in a patient with postmenopausal osteoporosis (OP) treated with 5 milligrams of zoledronic acid (ZOL) once yearly and one case in a patient receiving a placebo. The authors examined ONJ incidence in four additional clinical trials involving patients with osteopenia or OP who were treated with ZOL, and they analyzed levels of the bone resorption marker serum ß C-telopeptide (S-CTx) to assess its usefulness in predicting the risk of developing ONJ. METHODS: To determine ONJ prevalence, an independent committee conducted a masked review of the clinical trials' adverse events databases for cases meeting predefined criteria for ONJ. The committee collected S-CTx level data for subsets of patients from these trials. RESULTS: The results of the four additional clinical trials revealed no further cases of ONJ. The S-CTx levels commonly were lower than 0.15 nanograms per milliliter, with no correlation to the incidence of ONJ. CONCLUSIONS: In the clinically diverse group of 5,903 patients who received ZOL in five clinical trials, ONJ incidence was less than one in 14,200 patient treatment-years. Data from four clinical trials indicated that S-CTx levels lower than 0.15 ng/mL were common among patients receiving ZOL for treatment of OP and were not associated with ONJ. CLINICAL IMPLICATIONS: Occurrences of ONJ have been rare in patients with OP who are receiving ZOL. Whereas low S-CTx values may be common in patients receiving bisphosphonates for OP therapy, they are not associated necessarily with an increased risk of developing ONJ.

Usefulness of self-reported periodontal disease to identify individuals with elevated inflammatory markers at risk of cardiovascular disease.

Periodontal disease has been associated with cardiovascular disease (CVD), and inflammation may represent a common pathophysiology. Oral health screening in the context of CVD risk assessment represents a potential opportunity to identify individuals at risk for CVD. The purposes of this study were to determine if self-reported oral health status is independently associated with inflammatory markers and if oral health assessment as part of CVD risk screening can identify at-risk individuals without traditional CVD risk factors. A baseline analysis was conducted among participants in the National Heart, Lung, and Blood Institute's Family Intervention Trial for Heart Health (FIT Heart; n = 421, mean age 48 +/- 13.5 years, 36% nonwhite) without CVD or diabetes who underwent standardized assessment of oral health, lifestyle, CVD risk factors, and the inflammatory markers high-sensitivity C-reactive protein and lipoprotein-associated phospholipase A(2). Statistical associations between oral health, risk factors, and inflammatory markers were assessed, and logistic regression was used to adjust for effects of lifestyle and potential confounders. Periodontal disease was independently associated with being in the top quartile of lipoprotein-associated phospholipase A(2) compared with the lower 3 quartiles (odds ratio 1.9, 95% confidence interval 1.1 to 3.2) after adjustment for lifestyle and risk factors. Histories of periodontal disease were reported by 24% of non-overweight, non-hypertensive, non-hypercholesterolemic participants, and of these participants, 37% had elevated high-sensitivity C-reactive protein (> or =3 mg/L) or lipoprotein-associated phospholipase A(2) (> or =215 ng/ml) levels. In conclusion, self-reported periodontal disease is independently associated with inflammation and common in individuals without traditional CVD risk factors.

Comparison of levels of inflammatory mediators IL-1beta and betaG in gingival crevicular fluid from molars, premolars, and incisors during rapid palatal expansion.

INTRODUCTION: Previously, we reported fluctuation of the levels of the inflammatory mediators interleukin-1beta (IotaL-1beta) and beta-glucuronidase (betaG) in gingival crevicular fluid (GCF) from the maxillary first molars in adolescents undergoing rapid palatal expansion. In this study, we compared the responses of IL-1beta and betaG in the GCF of the maxillary first molars, first premolars, and central incisors during palatal expansion at the same patients. METHODS: Nine patients requiring palatal expansion were selected at the postdoctoral orthodontic clinic at Columbia University College of Dental Medicine. Each patient received periodontal prophylaxis and instructions in proper home care including rinsing with chlorhexidine. Four weeks after periodontal prophylaxis, a modified hyrax appliance was placed. The jackscrew was activated twice daily until the appropriate expansion was achieved. GCF samples were collected before and after periodontal prophylaxis and during passive wearing of the appliance, active orthodontic treatment, and retention. Fluid samples were collected with filter paper strips and analyzed by ELISA and time-dependent fluorometry for IL-1beta and betaG, respectively. The values recorded after periodontal prophylaxis were used as the baseline. Paired t tests were used to compare mediator levels at baseline with the levels obtained at each subsequent observation. RESULTS: The results validate that IL-1beta and betaG are present in the GCF of adolescents, and, although their level decreases after a strict regimen of plaque control, it increases during orthodontic or orthopedic movement. Moreover, this study demonstrates that both heavy and light forces evoke increased levels of IL-1beta and betaG, stronger forces cause higher levels of inflammatory mediators, and both IL-1beta and betaG respond to direct and indirect application of mechanical force to teeth. CONCLUSIONS: This investigation corroborates previous findings that an inflammatory process occurs during application of mechanical force to teeth. Although this inflammation is considered relatively aseptic, additional inflammation, such as that induced by plaque accumulation, must be avoided during orthodontic or orthopedic treatment.

Osteonecrosis of the jaw and bisphosphonate treatment for osteoporosis.

A potential side effect associated with bisphosphonates, a class of drugs used in the treatment of osteoporosis, Paget's disease and metastatic bone disease, is osteonecrosis of the jaw (ONJ). The incidence of ONJ in the general population is unknown; this rare condition also may occur in patients not receiving bisphosphonates. Case reports have discussed ONJ development in patients with multiple myeloma or metastatic breast cancer receiving bisphosphonates as palliation for bone metastases. These patients are also receiving chemotherapeutic agents that might impair the immune system and affect angiogenesis. The incidence or prevalence of ONJ in patients taking bisphosphonates for osteoporosis seems to be very rare. No causative relationship has been unequivocally demonstrated between ONJ and bisphosphonate therapy. A majority of ONJ occurs after tooth extraction. Furthermore, the underlying risk of developing ONJ may be increased in osteoporotic patients by comorbid diseases. Treatment for ONJ is generally conservative.

Incidence of osteonecrosis of the jaw in women with postmenopausal osteoporosis in the health outcomes and reduced incidence with zoledronic acid once yearly pivotal fracture trial.

BACKGROUND: The authors determined incidence of osteonecrosis of the jaw (ONJ) in a large, prospective three-year clinical trial of zoledronic acid in women with postmenopausal osteoporosis (PMO). METHODS: A total of 7,714 women with PMO received intravenous zoledronic acid 5 mg or a placebo. No spontaneous reports of ONJ were received. An independent, blinded adjudication committee searched the trial's adverse event database by using 60 terms. On an ongoing basis, the committee reviewed the identified events, and it defined ONJ as exposed bone in the maxillofacial area with delayed healing for more than six weeks despite appropriate care. RESULTS: One participant who received a placebo and one participant who received zoledronic acid experienced delayed healing associated with infection. Both conditions resolved after antibiotic therapy, débridement or both. CONCLUSION: The occurrence of ONJ is rare in a PMO population, and delayed healing of lesions can occur with and without bisphosphonate use over three years. CLINICAL IMPLICATIONS: The low incidence of ONJ must be assessed in the context of the clinical benefit of zoledronic acid therapy in reducing hip, vertebral and nonvertebral fractures in this at-risk population. There is no evidence to suggest that healthy patients with osteoporosis who are receiving bisphosphonates require any special treatment beyond routine dental care or to support altering standard treatment practices.