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Abstract 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. Self-reported invasive OPEs were common in women treated with denosumab up to 10 years and were associated with increased ONJ incidence; however, the overall rate of ONJ was low.

Photobiomodulation is a safe option for controlling pain, edema, and trismus when applied postoperatively in third molar surgery. However, administration prior to surgery has been under-explored. This study aims to explore the effectiveness of pre-emptive photobiomodulation in reducing postoperative edema in impacted lower third molar extractions. Two groups of healthy individuals undergoing tooth extraction will be randomly assigned: Control group receiving pre-emptive corticosteroid and simulated photobiomodulation, and Photobiomodulation Group receiving intraoral low-intensity laser and extraoral LED cluster application. The primary outcome will be postoperative edema after 48 h. The secondary outcomes will be pain, trismus dysphagia, and analgesic intake (paracetamol). These outcomes will be assessed at baseline as well as two and seven days after surgery. Adverse effects will be recorded. Data will be presented as means ± SD and a p-value < 0.05 will be indicative of statistical significance.

Wound closure technique is an operative factor that influences early post-operative complications after third molar surgery. This study investigates and compared the effectiveness of two closure techniques, primary closure and healing by second intention of the oblique incision on postsurgical discomfort after mandibular third molar surgery. This is a prospective, randomized, double-blind, split mouth controlled trial. Surgical sites were divided into two groups Control group received simple sutures in both alveolar crest incision and oblique incision and intervention group received simple sutures in alveolar crest incision, while the oblique incision healed by second intention. All the patients were instructed to measure pain according to visual analogue scale (VAS) in postoperative period, swelling, mouth opening was assessed at 72h and 7 days after surgery. The wound healing was assessed on day 7. Thirty-five patients, who had bilateral impacted third molars of similar surgical difficulty, were recruited. Thirty-one successfully completed the study. Patients in the second intention group had significantly less pain at 24h (p < 0.27). and 48h (< 0.001), had significantly less swelling (< 0.001) and trismus (< 0.001) and patients submitted to primary closure had a better evaluation of the Landry index (p < 0.001). Healing by second intention of the oblique relaxing incision by partial surgical wound closure, in our study, were superior to the primary closure in reduction of post-operative pain, swelling and trismus. This trial is registered at Brazilian Registry of Clinical Trials-ReBEC -UTN: RBR-5fxbqsf (https://ensaiosclinicos.gov.br/rg/RBR-5fxbqsf).

Abstract ObjectivesThis study aimed to improve the performance and mode of administration of a glass-reinforced hydroxyapatite synthetic bone substitute, Bonelike by Biosckin® (BL®), by association with a dextrin-based hydrogel, DEXGEL, to achieve an injectable and moldable device named DEXGEL Bone.MethodsTwelve participants requiring pre-molar tooth extraction and implant placement were enrolled in this study. BL® granules (250–500 µm) were administered to 6 randomized participants whereas the other 6 received DEXGEL Bone. After 6 months, a bone biopsy of the grafted area was collected for histological and histomorphometric evaluation, prior to implant placement. The performance of DEXGEL Bone and BL® treatments on alveolar preservation were further analyzed by computed tomography and Hounsfield density analysis. Primary implant stability was analyzed by implant stability coefficient technique.ResultsThe healing of defects was free of any local or systemic complications. Both treatments showed good osseointegration with no signs of adverse reaction. DEXGEL Bone exhibited increased granule resorption (p = 0.029) accompanied by a tendency for more new bone ingrowth (although not statistically significant) compared to the BL® group. The addition of DEXGEL to BL® granules did not compromise bone volume or density, being even beneficial for implant primary stability (p = 0.017).ConclusionsThe hydrogel-reinforced biomaterial exhibited an easier handling, a better defect filling, and benefits in implant stability.Clinical relevanceThis study validates DEXGEL Bone safety and performance as an injectable carrier of granular bone substitutes for alveolar ridge preservation.Trial registrationEuropean Databank on Medical Devices (EUDAMED) No. CIV-PT-18–01-02,705; Registo Nacional de Estudos Clínicos, RNEC, No. 30122.

Background Among the post-surgical complications of lower wisdom teeth surgery, swelling is considered by patients one of the most impairing, with both social and biological influences and impacting patients' quality of life. Aim of the study was to evaluate the swelling following the osteotomy when performed with drilling burs versus piezo-electric instruments in the mandibular impacted third molar extraction, using a facial reconstruction software. Materials and methods A randomized, split-mouth, single-blind study was conducted on patients, ranging between 18 and 40 years of age, requiring lower third molars extraction and referred at the Oral Surgery Unit of the School of Dentistry of the University of Messina. Twenty-two patients were recruited during an 8 months period according to the following criteria: good general health conditions; bilateral, symmetrical, impacted third molars; no use of medication that would influence or alter wound healing; no temporomandibular joint disorder history; no smoking. All patients underwent bilateral surgical removal. For each patient, a facial scan was obtained prior to the surgical procedures. The two extractions were conducted performing, in a randomized way, osteotomy with rotatory burs or use of piezo surgical instruments. Facial scans were repeated at 3 and 7 days after the surgical procedures. Volumetric differences were calculated via superimposition using a dedicated software. The data obtained were processed using paired t-test. Results The results obtained from our study showed no significant differences between two groups regarding post-operative swelling. To the best of our knowledge, this study represents the first experience of using an objective method that can be reproducible on the collection of patients' clinical parameters. Conclusions The 3D digital analysis, in the evaluation of facial swelling, is a technique of simple application, objective, reproducible, reliable, decreasing the variables of error. Based on these data, it is possible to conclude that piezo surgery is a safe way for performing the osteotomies during third molar surgery. However, regarding the post-operative swelling, it does not show an advantage over classical rotary instruments. Trial registration Registered on ClinicalTrials.gov (ID: NCT05488028, on 04/08/2022). Approved by Ethical Committee of Messina: (ID 01–2020, on 27/04/2020).

Background-objective(s) This randomized, split-mouth study aimed to compare postoperative complications following the surgical extraction of impacted lower third molars using piezosurgery versus conventional rotary instruments. Materials and methods Twenty-one patients, aged 18–35 years, with bilaterally and symmetrically impacted lower third molars, were randomly assigned to undergo extraction using piezosurgery on one side and conventional rotary instruments on the other. Results The piezosurgery method required a longer operation time. However, it resulted in quicker resolution of postoperative swelling by the 7th day compared to the conventional method, where swelling persisted longer. Mandibular angle-tragus measurements were significantly higher with the conventional method on the 1st, 3rd, and 7th postoperative days. Although mouth opening decreased significantly after piezosurgery, it returned to preoperative levels by the 7th day, outperforming the conventional method. Postoperative pain was notably higher with the conventional method during the first four days but showed no significant difference from the 5th day onward. Alveolar bone healing was significantly better with piezosurgery at the 3rd and 6th months. Temporary paresthesia occurred in one patient from the conventional group, resolving within four weeks. Neither method resulted in alveolar osteitis. Conclusion(s) Within the study's limitations, piezosurgery demonstrated a reduction in postoperative discomfort, suggesting its advantage in enhancing patient recovery following lower third molar extractions. Clinical significance Piezosurgery, when used appropriately, can reduce postoperative complications compared to conventional methods. Clinicians should be aware of its indications, benefits, and potential challenges. Trial registration This study was registered as a clinical trial to the ClinicalTrials.gov, and the registration ID is NCT06262841 ( https://clinicaltrials.gov/study/NCT06262841 ).

Background The aim of this prospective randomized controlled trial was to compare the effects of orthodontic and traditional extraction methods on nerve injury following the extraction of impacted third molars close to the inferior alveolar nerve and to demonstrate the impact of factors such as gender, age, systemic diseases, the side of the third molar, its position, and classification on nerve recovery. Methods Patients with impacted third molars close to the inferior alveolar nerve and an indication for impacted third molar extraction were included in the study. The patients were divided into two groups according to the surgical approach to be applied. Results Preoperative 2-point discrimination (2PD) test values, as well as postoperative 2PD test and visual analog scales (VAS) values on the 7th day, 14th day, and 1st, 3rd, and 6th months, were compared. In the traditional extraction group, the results of the 2PD test were statistically significantly higher on the 7th day, 14th day, 1 month, and 3 months compared to the orthodontic extraction group ( P  < 0.05). Sex, age, systemic disease, M3 side, position, and classification had no statistically significant effect on nerve recovery ( P  > 0.05). Conclusions The orthodontic extraction was found to be safer than traditional extraction in terms of nerve injury for high-risk M3s. Clinical trial registration This study was registered on www.clinicaltrials.govin13/02/2024 . Clinical trial number: NCT06270784.

This study aims to evaluate the effect of Nd:YAG laser therapy (NdLT) on postoperative pain, swelling, and trismus after mandibular third molar (M3) surgery. Three hundred patients were randomly divided into the Nd group (n = 100), medication group (n = 100), and Nd+medication (Nd+m) group (n = 100). The WHARFE classification system was used to assess surgical difficulty. After surgery, the Nd group was irradiated by the Nd:YAG laser in very long-pulsed mode (VLP, pulse duration 1 ms, 20 Hz, 4 W, R21-C3) in 6 regions of the extraction socket with a total energy of 300 J. For the medication group, dexamethasone 0.75 mg and loxoprofen 60 mg were prescribed immediately and every 12 h thereafter for 3 days. The Nd+m group received both treatments mentioned above. Pain assessment was performed at 6, 24, 48, and 72 h postoperatively using the visual analog scale (VAS). Swelling was evaluated by changes in the distance from (1) the tragus to the labial commissure, (2) the tragus to the pogonion, and (3) the mandibular angle to the lateral canthus preoperatively and 72 h postoperatively. Trismus was assessed by the change in maximum mouth opening. Groups Nd and Nd+m had lower VAS scores at 6 h, 24 h, and 48 h (F = 13.80, p = 0.00), but the difference between the two groups was not significant (F = 1.34, p = 0.11). However, no significant difference was observed at 72 h (p = 0.10). There was no significant difference in swelling or trismus among the three groups (p > 0.05). NdLT is an effective approach to improve complications after M3 surgery.

Abstract IntroductionSince antimicrobial resistance, caused by various factors including antibiotic overuse and abuse, is a severe challenge, the necessity of perioperative antibiotic prophylactic for surgical third molar removal remains a contentious topic. This study determined whether perioperative antibiotic prophylaxis can reduce surgical site infections (SSIs), swelling, and pain in the case of surgical removal of wisdom teeth.Material and methodsA randomized, double-blind, placebo-controlled clinical trial with a split-mouth design. A study medication of 2 g amoxicillin, administered 1 h before the third molar removal, followed by 1.5 g each for the first 3 postoperative days, was compared with placebo medication. The primary outcome variable (SSI), secondary clinical parameters (swelling and trismus), and patient-centered outcome measures (bleeding, swelling, pain, and pain medication intake) were documented until postoperative day 7. Statistical analyses were done with a paired t test, t test for independent samples, Chi-square test, and McNemar test, including effect sizes.ResultsPrimary outcome SSI, in total 11%, and clinical parameters swelling and trismus were not significantly different between the two groups. The patient-centered outcome measures (bleeding, swelling, and pain) did not significantly differ, except for postoperative bleeding in the EG on day 0. No significant result was found with pain medication intake postoperative on days 0–7.ConclusionsPerioperative administration of oral antibiotics neither revealed additional benefits in patient-related outcome measures nor reduced postoperative complications compared with the placebo group indicated at routine surgical removal of noninflamed wisdom teeth.Clinical relevanceTaking antimicrobial resistance into account, clear recommendations for administering drugs, particularly antibiotics, are critical in oral surgery.

ObjectivesThis prospective study introduced a digitally designed sectioning guide and evaluated its feasibility for the extraction of horizontally impacted lower third molars.Materials and methodsThis study included 38 horizontally impacted lower third molars, randomly divided into experimental and control groups. The teeth were extracted using a 3D-printed titanium surgical guide in the experimental group; free-hand extractions were performed in the control group. The surgical duration, tooth sectioning duration, cortical bone perforation, and postoperative complications, including pain, swelling, trismus, dry socket, infection, and hemorrhage, were evaluated.ResultsAlthough not statistically significant, guided surgery tended to reduce the number of tooth sectioning steps compared to free-hand extractions. There were no cases of cortical bone perforation in the experimental group. Although the surgical duration was greater in the experimental group (p < 0.05), there were no differences in postoperative pain, swelling, and trismus. There were no cases of postoperative infection and hemorrhage in either group.Conclusions3D-printed titanium surgical guides had superior accuracy and safety compared to free-hand surgery. Further studies with larger sample sizes are required to verify these findings.Clinical relevanceThe template improved the safety of tooth sectioning during impacted lower third molar surgery and resulted in a more predictable extraction. The narrow sectioning groove could fit comfortably with hypertrophic soft tissues in the posterior mandible.