Diagnostic accuracy comparing OPT and CBCT in the detection of non-vital bone changes before tooth extractions in patients with antiresorptive intake.

OBJECTIVES: To compare the diagnostic accuracy in detecting early non-vital bone changes between orthopantomography (OPT) and cone-beam computed tomography (CBCT) in correlation with histopathological findings before tooth extractions in patients with antiresorptive (AR) intake. SUBJECTS: Patients with an indication tooth extraction who had received OPT and CBCT preoperatively while or after undergoing AR treatment were prospectively enrolled over a 24-month period in the progesterone in spontaneous miscarriage (PRISM) trial. Imaging studies were randomly analyzed by three examiners for early non-vital bone changes using specific predefined characteristics and a 5-level scale (1 definite absence of criteria to 5 definite presence of criteria). Sensitivity and specificity values were calculated in correlation with the histopathologically evaluated bone samples at the time point of tooth extraction. RESULTS: One hundred thirty patients with 237 treated extraction sites met the inclusion criteria. For all images evaluated by all examiners, CBCT (430/492; 87.4%; receiver operating characteristic [ROC]: area under the curve [AUC] = 0.88; p < 0.001) was more likely to detect histopathologically confirmed non-vital bone than the OPT (132/492; 26.8%; ROC: AUC = 0.562; p = 0.115). CONCLUSIONS: In the detection of non-vital bone changes, CBCT is superior to OPT in both sensitivity and specificity. Specific imaging characteristics allow for the prediction of early non-vital bone changes already at the time before tooth extractions.

Wound closure and alveoplasty after preventive tooth extractions in patients with antiresorptive intake-A randomized pilot trial.

OBJECTIVES: To compare success rates between the sub-periosteal prepared (SPP) muco-periosteal flap and the epi-periosteal prepared (EPP) mucosa flap and the feasibility of alveoplasty after surgical tooth extractions in patients undergoing/after antiresorptive treatment. SUBJECTS: Patients with an indication for preventive tooth extraction undergoing/after antiresorptive treatment were enrolled over a 24-month period in a parallel-group randomized clinical pilot trial and randomly assigned for primary wound closure to either the SPP or the EPP group. The primary outcome was treatment failure 8 weeks after surgery. To assess the feasibility of alveoplasty, necrotic bone changes at the time point of tooth extraction were evaluated. RESULTS: One hundred and sixty patients were randomized to the SSP (n = 82) or the EPP (n = 78) group. One hundred and fifty-seven patients met the primary endpoint 8 weeks after surgery with five treatment failures for the SPP group (6.3%) and 18 (23.4%) for the EPP group (p = .004). A significant relationship (p < .0001) was observed between symptomatic teeth and non-vital bone found in 54.8% of all biopsies. CONCLUSIONS: The strong superiority of the muco-periosteal flap as primary wound closure revealed the feasibility and effectiveness of the study. The large number of necrotic biopsies emphasizes the importance of alveoplasty as a preventive measure.

Clinical Performance of Posterior Inlay-Retained and Wing-Retained Monolithic Zirconia Resin-Bonded Fixed Partial Dentures: Stage One Results of a Randomized Controlled Trial.

PURPOSE: To prospectively compare the clinical performance of posterior inlay-retained and wing-retained monolithic zirconia fixed partial dentures (FPDs). MATERIALS AND METHODS: After simple randomization, 30 participants received either one inlay-retained (n = 15; mean age: 56.38 ± 12.70 years; 10 men [66.7%]) or one wing-retained (n = 15; mean age: 45.90 ±13.24 years; 7 men [46.7%]) FPD. The restorations, which predominantly replaced first molars, were fabricated from translucent, 3 mol% yttria-stabilized zirconia and attached with self-etching resin cement. Restorations and abutment teeth were clinically followed up for complications one week and 3, 6, and 12 months after cementation. Plaque and gingival scores, probing pocket depths, and attachment levels were recorded for the abutment and contralateral reference teeth both before treatment and during follow-up examinations. The restorations were also assessed in accordance with FDI World Dental Federation criteria. Statistical analyses were conducted with R (α = 0.05). An adaptive, 2-stage study design based on the incidence of failure-free survival in the groups after 12 months (stage 1) was implemented. Predefined decision rules were used to determine whether further recruitment (stage 2) would enable the detection of a statistically significant difference between the restoration designs with sufficient power. RESULTS: During 12 months, only one wing retainer debonded which required removal of the FPD. Failure-free survival was thus 93.3% for wing-retained and 100% for inlay-retained FPDs (log-rank test, p = 0.317). Moderate aftercare resulted in intervention-free rates of 78.8% and 86.7% for inlay-retained and wing-retained restorations, respectively (log-rank test, p = 0.605). Based on FDI World Dental Federation criteria, all restorations were acceptable at the 12-month follow-up (Fisher-Boschloo test, p = 0.161). Plaque, gingival, and periodontal scores remained practically unchanged from before treatment to the 12-month follow-up. Recruitment was stopped after stage 1 because, based on the small difference in the incidence of failure-free survival in the groups, it was accepted that it would not be possible to recruit the necessary number of participants to show a statistically significant difference between the retainer designs. CONCLUSIONS: Both inlay-retained and wing-retained monolithic zirconia resin-bonded FPDs performed well for the 12-month, short-term follow-up period.

Comparison of Different Antibiotic Regimes for Preventive Tooth Extractions in Patients with Antiresorptive Intake-A Retrospective Cohort Study.

In the present study, the impacts on success rates between three different antibiotic regimes in patients receiving preventive tooth extraction during/after antiresorptive treatment were compared. For the retrospective analysis, we enrolled patients who had undergone tooth extraction from 2009 to 2019 according to the specified preventive conditions under antiresorptive therapy. Three antibiotic regimens were distinguished: (Group 1) intravenous for 7 days, (Group 2) oral for 14 days, and (Group 3) oral for 7 days of application. The primary endpoint was the occurrence of medication-related osteonecrosis of the jaw at 12 weeks after surgery. A total of 760 patients and 1143 extraction regions were evaluated (Group 1 n = 719; Group 2 n = 126; Group 3 n = 298). The primary endpoint showed no significant difference in the development of medication-related osteonecrosis of the jaw between the groups studied (Group 1 n = 50/669 (7%); Group 2 n = 9/117 (7%); Group 3 n = 17/281 (6%); p = 0.746). Overall, the success rate was 93% after intervention when preventive measures were followed. With the same success rate, a reduced, oral administration of antibiotics seems to be sufficient regarding the possible spectrum of side effects, the development of resistance and the health economic point of view.

Osteoradionecrosis of the Jaw-Comparison between Bone and Soft Tissue Injury and Their Influence on Surgical Outcomes-A Retrospective Cohort Study.

Surgical therapy of osteoradionecrosis of the jaw (ORN) is challenging and requires treatment of the affected hard and soft tissue. To understand how tissue injury after irradiation influences surgical outcomes, the objective of this study was to find out whether (a) bone-related, (b) soft tissue-related, and (c) treatment-related parameters influence the surgical success of patients with ORN. A total of 175 patients (324 lesions) were included in this retrospective, single-center study. All patients were diagnosed with ORN and underwent surgical therapy. The primary outcome was complete soft tissue recovery (mucosa/skin) and the absence of symptoms 3 months after surgery. At the time of follow-up, 58% of patients (189 of 324 lesions) had intact intraoral or extraoral soft tissue. The extent of bone destruction had no effect on treatment success, whereas soft tissue injury due to fibrosis (OR: 0.344; CI 0.142-0.834; p = 0.01818) and xerostomia (OR: 0.163; CI 0.064-0.419; p = 0.00016) increased the probability of treatment failure. Soft tissue reconstruction with a microvascular graft improved therapeutic success compared to local wound closure (OR: 2.998; CI 1.371-6.555; p = 0.006). Thus, for the treatment of ORN, it is extremely important to pay attention not only to the extent of bone destruction but especially to soft tissue defects. Because the extent of soft tissue injury is a predictor for therapeutic success, it should influence the choice of surgical treatment.

Amitriptyline's anticholinergic adverse drug reactions-A systematic multiple-indication review and meta-analysis.

BACKGROUND: Half the US population uses drugs with anticholinergic properties. Their potential harms may outweigh their benefits. Amitriptyline is among the most frequently prescribed anticholinergic medicinal products, is used for multiple indications, and rated as strongly anticholinergic. Our objective was to explore and quantify (anticholinergic) adverse drug reactions (ADRs) in patients taking amitriptyline vs. placebo in randomized controlled trials (RCTs) involving adults and healthy individuals. METHODS: We searched electronic databases from their inception until 09/2022, and clinical trial registries from their inception until 09/2022. We also performed manual reference searches. Two independent reviewers selected RCTs with ≥100 participants of ≥18 years, that compared amitriptyline (taken orally) versus placebo for all indications. No language restrictions were applied. One reviewer extracted study data, ADRs, and assessed study quality, which two others verified. The primary outcome was frequency of anticholinergic ADRs as a binary outcome (absolute number of patients with/without anticholinergic ADRs) in amitriptyline vs. placebo groups. RESULTS: Twenty-three RCTs (mean dosage 5mg to 300mg amitriptyline/day) and 4217 patients (mean age 40.3 years) were included. The most frequently reported anticholinergic ADRs were dry mouth, drowsiness, somnolence, sedation, fatigue, constitutional, and unspecific anticholinergic ADRs. Random-effects meta-analyses showed anticholinergic ADRs had a higher odd's ratio for amitriptyline versus placebo (OR = 7.41; [95% CI, 4.54 to 12.12]). Non-anticholinergic ADRs were as frequent for amitriptyline as placebo. Meta-regression analysis showed anticholinergic ADRs were not dose-dependent. DISCUSSION: The large OR in our analysis shows that ADRs indicative of anticholinergic activities can be attributed to amitriptyline. The low average age of participants in our study may limit the generalizability of the frequency of anticholinergic ADRs in older patients. A lack of dose-dependency may reflect limited reporting of the daily dosage when the ADRs occurred. The exclusion of small studies (<100 participants) decreased heterogeneity between studies, but may also have reduced our ability to detect rare events. Future studies should focus on older people, as they are more susceptible to anticholinergic ADRs. REGISTRATION: PROSPERO: CRD42020111970.

APOS-antibiotic prophylaxis for preventing infectious complications in orthognathic surgery: study protocol for a phase III, multicentre, randomised, controlled, double blinded, clinical trial with two parallel study arms.

BACKGROUND: It is a constant debate among surgeons whether the use of prolonged postoperative antibiotics may reduce surgical site infection rates. As specific treatment guidelines are still lacking, many surgeons continue to use broad-spectrum antibiotics, causing not only increased costs but also contributing to the potential for antibiotic resistance. Hence, there is an urgent need for an appropriately designed prospective clinical trial, to investigate whether a prophylactic use of antibiotics after surgery actually decreases surgical site infections to a clinically relevant degree. METHODS: This study presents a multicentre, randomised, controlled, double-blinded, clinical trial with two parallel study arms to demonstrate that no postoperative antibiotic prophylaxis (AP) is not inferior to antibiotic prophylaxis with respect to surgical site infections in patients having undergone orthognathic surgery. The primary efficacy endpoint is defined as the occurrence of postoperative surgical site infections within 30 days of surgery. Secondary endpoints are further efficacy and subject-oriented parameters within 90 days after surgery. The entire trial is planned for 54 months, with an enrolment of 1420 patients over 39 months by 14 national participating centres. DISCUSSION: As a highly standardised procedure on an exceeding, healthy and young homogenous study population and identical processes all over the world, elective orthognathic surgery as clean-contaminated procedure provides comparable intervention groups with balanced baseline characteristics, comparable surgical duration, even when performed within multiple centres. Therefore, evaluating antibiotic prophylaxis after orthognathic surgery will be of high scientific value representable for other surgical procedures. TRIAL REGISTRATION: DRKS-German Clinical Trials Register- DRKS00022838 ; EudraCT No. 2020-001397-30. Registered on 29 March 2021.

Influence of Preventive Tooth Extractions on Quality of Life in Patients with Antiresorptive Intake-A Prospective Longitudinal Study.

BACKGROUND: To find out whether preventive tooth extractions in patients on antiresorptive therapy have a direct impact on the patients' overall quality of life (QoL); Methods: QoL using the five-level version of the EuroQol Group's EQ-5D instrument (EQ-5D-5L) was longitudinally assessed in N = 114 prospectively enrolled patients with indication of preventive tooth extraction over a period of 12 months. Patients were stratified as high-risk (malignant disease with bone metastasis or multiple myeloma, with monthly high-dose antiresorptive therapy delivered intravenously [bisphosphonate] or subcutaneously [denosumab]) and low-risk/osteoporosis patients (weekly low-dose antiresorptive therapy administered orally [bisphosphonate] or half-yearly subcutaneously [denosumab]). The measurement time points were 4 weeks preoperatively (T0), 2 months (T1) and 1 year postoperatively (T2), respectively. RESULTS: EQ-5D-5L index scores fell in a range from -0.21 to 1.00 in the low-risk group to 0.15 to 1.00 in the high-risk group. The t-test comparing the baseline index scores of both groups showed EQ-5D-5L index score in the low-risk group (0.708 ± 0.292) to be significantly smaller (p = 0.037) than in the high-risk group (0.807 ± 0.19). ANCOVA showed no significant differences in EQ-5D-5L index scores between the groups at T1 and T2. CONCLUSIONS: Preventive tooth extractions in patients undergoing antiresorptive treatment have no negative effect on QoL. Therefore, if indicated, preventive tooth extraction should not be omitted. Patient-oriented outcome measures are important to obtain a good risk-benefit balance for patient-specific treatment.