The Use of Statins as an Adjunctive Periodontal Disease Treatment: Systematic Review and Meta-Analysis.

BACKGROUND: the purpose of this systematic review was to assess the clinical and radiographic effect of subgingival-administered statins as an adjunct periodontal treatment in patients with periodontitis. METHODS: Electronic literature searches in Medline/PubMed and the Cochrane Library were conducted to identify all relevant articles. Eligibility was based on inclusion criteria which included Randomized Controlled Trials (RCTs) published after 2010, where the periodontal variables were assessed before and after periodontal treatment in combination with a statin administration. The risk of bias was assessed with the ROBINS-2 tool. The outcome variables were probing depth, clinical attachment level, bleeding on probing, and bone fill in systematically healthy patients, patients with type 2 diabetes, and smokers. RESULTS: Out of 119 potentially eligible articles, 18 randomized controlled trials were included with a total of 1171 participants. The data retrieved from the meta-analysis showed the positive effect that statins have as an adjunctive periodontal disease treatment. When comparing the different types of statins, the PD reduction in the Simvastatin group was significantly higher than the Atorvastatin group at 6 months and at 9 months, while no differences between statins were found for the rest of the outcomes. Over 66% of the articles presented an overall risk of bias with some concerns, making this a limitation of this present RCT. CONCLUSIONS: The adjunct administration of statins has proven to have a positive effect on the periodontium by improving both clinical and radiographic parameters by a considerable margin.

Ion release and local effects of titanium metal particles from dental implants: An experimental study in rats.

BACKGROUND: The objective of this study was to evaluate the accumulation of ions in blood and organs caused by titanium (Ti) metal particles in a mandibular defect in rats, together with a description of the local reaction of oral tissues to this Ti alloy debris. METHODS: Twenty Sprague-Dawley rats were randomly distributed into three groups: an experimental group with a mandibular bone defect filled with metallic debris obtained by implantoplasty; a positive control group; and a negative control group. Thirty days after surgery, the rats were euthanized and perilesional tissue surrounding the mandibular defect was removed, together with the lungs, spleen, liver, and brain. Two blood samples were collected: immediately before surgery and before euthanasia. The perilesional tissue was histologically analyzed using hematoxylin-eosin staining, and Ti, aluminum, and vanadium ion concentrations in blood and organs were measured by TQ-ICP-MS. Descriptive and bivariate analyses of the data were performed. RESULTS: All rats with implanted metal debris showed metal particles and a bone fracture callus on the osseous defect. The metal particles were surrounded by a foreign body reaction characterized by the presence of histiocytes and multinucleated giant cells (MNGCs). The experimental group had a significant higher concentration of Ti ions in all studied organs except lung tissue (p < 0.05). In addition, there were more V ions in the brain in the experimental group (p = 0.008). CONCLUSIONS: Although further studies are required to confirm the clinical relevance of these results, Ti metal particles in the jaw might increase the concentration of metal ions in vital organs and induce a foreign body reaction.

Evaluation of the inflammatory and osteogenic response induced by titanium particles released during implantoplasty of dental implants.

Implantoplasty is a mechanical decontamination technique that consists of removing the threads and polishing and smoothing the dental implant surface. During implantoplasty there is a large release of titanium metal particles that might provoke a proinflammatory response and reduce the viability of osteogenic cells. We analyze the inflammatory and osteogenic response induced by Ti6Al4V particles released during implantoplasty and by as-received commercially pure Ti particles. Macrophages stimulated with metal particles obtained by implantoplasty and with as-received Ti particles showed an increased proinflammatory expression of TNF-α and a decreased expression of TGF-ß and CD206. Regarding cytokine release, there was an increase in IL-1ß, while IL-10 decreased. The osteogenic response of Ti6Al4V extracts showed a significant decrease in Runx2 and OC expression compared to the controls and commercially pure Ti extracts. There were no relevant changes in ALP activity. Thus, implantoplasty releases metal particles that seems to induce a pro-inflammatory response and reduce the expression of osteogenic markers.

Prevalence of Periodontitis among Patients Diagnosed with Marfan Syndrome: A Cross-Sectional Study Comparing Samples of Healthy Patients.

Periodontitis is an inflammatory condition caused by a bacterial plaque and characterized by progressive destruction of the tooth-supporting apparatus. Patients with Marfan syndrome (MFS) exhibit a connective tissue disorder, which can also affect oral soft and hard tissue. Thus, the aims of this cross-sectional study were to assess the association between periodontitis and MFS and secondly, to compare periodontal parameters and prevalence of disease with a control group (CG) without MFS. 152 patients (MFS = 76, CG = 76) were recruited to evaluate the following periodontal parameters: probing depth, gingival margin, clinical attachment level, plaque index, and bleeding on probing. The 2017 World Workshop guideline was followed for the diagnosis of the periodontal status. A multivariate analysis was performed using a multinomial logistic regression adjusted for age, gender, and smoking. The level of significance required was p < 0.05. Patients with MFS did not show a higher prevalence of periodontitis compared to the CG. However, patients with MFS did have higher values in probing depth, gingival recession, clinical attachment level, and plaque index compared to the CG patients (p < 0.05). In conclusion, although similar prevalence of periodontitis was found among the studied groups, MFS patients showed worse periodontal parameters.

Prevalence of intraoperative and postoperative iatrogenic mandibular fractures after lower third molar extraction: A systematic review.

BACKGROUND: The surgical extraction of the lower third molars is one of the most common procedures in oral surgery, and this surgical operation can cause intra- and postoperative complications such as pain, trismus, bleeding, infection, oedema, inferior alveolar nerve injuries, displacement of teeth to neighbouring spaces and mandibular fractures. The aim of this systematic review is to report the prevalence of mandibular fractures that occur intra- and postoperatively in patients who have undergone surgical removal of the lower third molar. MATERIAL AND METHODS: An electronic database search for articles published in Cochrane, PubMed (MEDLINE) and Scopus was conducted using the key words "Molar, Third"; "Mandibular Fractures"; "Molar Third, Removal"; "Molar Third, Complications"; "Dental Extractions, Complications"; "Mandibular Fractures, Third molar removal". The inclusion criteria were articles including at least 10 patients and were published in English in the last 10 years. The exclusion criteria were nonhuman studies and case reports. RESULTS: Postoperative mandibular fractures after 3MI occur more frequently in male patients between the ages of 40 and 60 and are caused by premature chewing force. The parameters that most frequently characterise mandibular fractures at the mandibular angle are deeply impacted lower third molars, Class II and III, B and C, according to the Pell & Gregory classification system, mesioangular according to the Winter's classification, and are located on the left mandibular side.. CONCLUSIONS: Mandibular fractures can be predicted with adequate preoperative planning for each case and identify the related risk factors for this complication. Key words:Molar, Third; Mandibular Fractures; Molar Third, Removal; Molar Third, Complications; Dental Extractions, Complications; Mandibular Fractures, Third molar removal.

Intraarticular injections of platelet rich plasma and plasma rich in growth factors with arthrocenthesis or arthroscopy in the treatment of temporomandibular joint disorders: A systematic review.

Intra-articular platelet rich plasma injections [PRP] or platelet rich growth factors [PRGF] injections have been used as therapeutic treatment options for patients with temporomandibular joint disorder [TMD] in recent years. The purpose of this paper is to evaluate the level of the available scientific evidence in the current literature on the benefits of applying PRP or PRGF injections to patients with TMD simultaneously or after arthrocentesis or arthroscopy to reduce post-operative pain and improve temporomandibular joint function. This systematic review was conducted according to PRISMA criteria and an electronic database search was carried out in the PubMed, Scopus and Cochrane databases during May 2021. The patients in the study group were injected with intra-articular PRP or PRGF simultaneously or after arthrocentesis or arthroscopy while the patients in the control group had arthrocentesis or arthroscopy without an intra-articular injection or received an injection of hyaluronic acid or Ringer's lactate solution. Eight randomised controlled clinical trials were selected. The PRP and PRGF intra-articular injections demonstrated significant differences in terms of pain reduction in three studies and improved mandibular function in two. The treatment with PRP or PRGF intra-articular injections demonstrated slightly better clinical results but of little significance in comparison with the control group. Evidence of their effectiveness is crucial to establish them as non-invasive treatments and as an affordable option for treating some types of TMDs. In accordance with Evidence-based dentistry principles, this review has been assigned a C recommendation.

Critical assessment of the latest classification of jaw cysts proposed by the World Health Organization (2017).

BACKGROUND: The fourth edition of the World Health Organization Classification of Head and Neck Tumors was published in January 2017, and includes a classification of odontogenic tumors and odontogenic cysts. The present review assesses the changes made in this new classification in relation to odontogenic and non-odontogenic jaw cysts. MATERIAL AND METHODS: An electronic search was conducted in the Cochrane Library, PubMed-MEDLINE and Scopus databases using the search terms: "odontogenic cyst" "WHO classification" "update". Studies written in English and published between January 2005 and April 2020 with a high level of scientific evidence were included, while studies not published in English, epidemiological studies, and studies with a low level of scientific evidence were excluded. RESULTS: The initial search identified 311 articles, and after the deletion of duplicates, 7 studies were selected for full-text assessment. After excluding two studies that failed to provide relevant information and had a low level of scientific evidence, 5 articles were finally included and stratified according to their level of scientific evidence based on the SORT (Strength of Recommendation Taxonomy) criteria. CONCLUSIONS: The incorporation of odontogenic and non-odontogenic cysts to the head and neck tumors classification underscores the recognition of the WHO of these important disorders of the jaws. Based on the current evidence, there is controversy as to whether odontogenic keratocysts should be regarded as cystic lesions or as neoplasms, though there is no such controversy in relation to calcifying odontogenic cysts. On the other hand, orthokeratinized odontogenic cysts have been included in the classification as a single entity differentiated from odontogenic keratocysts, while residual cysts have been removed from the classification. Key words:Odontogenic cyst, WHO classification, pseudocyst.

Intraarticular injections of hyaluronic acid in arthrocentesis and arthroscopy as a treatment of temporomandibular joint disorders: A systematic review.

Objective: To evaluate the benefits of hyaluronic acid intraarticular injection (HA IAI), in conjunction with minimally invasive surgery (arthrocentesis or arthroscopy), as a therapeutic option for temporomandibular joint disorders.Methods: An electronic search in PubMed, Cochrane Library, and Scopus databases was conducted in order to answer the following PICOS question: "In clinical trials with patients treated with arthroscopy or arthrocentesis, did the subsequent use of HA IAI provide a better control of postoperative pain and temporomandibular joint function compared to those patients who did not receive it?"Results: Following PRISMA criteria, six randomized controlled clinical trials were selected. HA IAI showed significant differences in terms of pain reduction in three of them and improvement of mandibular function in two, compared to the control group.Conclusion: Based on scientific evidence, the level of recommendation found regarding this type of intervention is type B (recommendation based on inconsistent or limited-quality patient-oriented evidence).

Indications of the extraction of symptomatic impacted third molars. A systematic review.

BACKGROUND: A literature review was made to determine when third molar (3M) extraction is recommended in symptomatic patients and when it is not recommended. MATERIAL AND METHODS: A Medline (PubMed) and EMBASE search was made for articles related to indications for the extraction of 3Ms, published in the last 10 years and up until September 2018. RESULTS: The electronic search yielded 175 articles. After eliminating duplicates, a total of 173 articles were subjected to review of the title and abstract. Only 19 studies were finally included in the systematic review. There was a well documented increase in morbidity associated to impacted 3Ms (non-restorable caries, fracture, infection, periodontal disease, repeated pericoronitis, cysts and tumors), and in the presence of disease, extraction was considered to be indicated. The extraction of 3Ms with signs and/or symptoms of periodontal disease improved periodontal health at the distal surface of the second molar. Postoperative quality of life of patients with symptomatic 3Ms and with disease improved after surgical extraction. CONCLUSIONS: Extraction is indicated in the presence of disease associated to an impacted 3M, whether symptomatic or not. In contrast, extraction is not indicated in the absence of infection or other associated disease conditions. Key words:Third molar, periodontal disease, periodontitis, pericoronitis, dental caries, occlusal caries, mandibular cysts, osteomyelitis, odontogenic tumor.

Simple bone cyst: A case report.

BACKGROUND: Simple bone cysts (SBC) are intraosseous cysts devoid of an epithelial lining, asymptomatic and appearing in the jaw. In general, SBCs are discovered incidentally and tooth displacement or pathological fractures are very unusual. MATERIAL AND METHODS: This study reports a 16 years old man that presented an asymtomatic radiolucent unilocular lesion in the right ascending ramus. Differencial diagnosis included odontogenic keratocyst and dentigerous cyst. One surgical intervention was performed and consisted in the curettage of the bone walls. The lesion and some small samples of the bone wall were sent for the anatomopathological study. RESULTS: The anatomopathological exam confirmed the diagnosis of simple bone cyst. There was no evidence of recurrence after 6 months of follow-up and bone regeneration was almost complete. CONCLUSIONS: Curettage is the technique of choice for SBC treatment. Control visits are necessary to check the absence of postoperative complications and bone regeneration. Key words:Simple bone cyst, traumatic bone cyst, intraosseous cyst, curettage.

Influence of incision on periodontal parameters after apical surgery: a meta-analysis.

INTRODUCTION: The aim of the present meta-analysis was to determine the effect of the different incision designs used in apical surgery on periodontal parameters. METHODS: An electronic search in Cochrane Library, Pubmed (MEDLINE), and Scopus was conducted on April 2020. Two independent investigators included clinical trials and prospective cohort studies comparing the influence of different incision designs used in apical surgery on gingival recession, periodontal probing depth, and clinical attachment level. A pairwise and network meta-analysis was performed in order to meta-analyze the direct and the indirect comparisons among the incision designs. RESULTS: Six articles were included for the qualitative and the quantitative syntheses, involving a total of 401 teeth (372 patients). The pairwise meta-analysis did not reveal statistically significant differences between the incision designs in any of the outcomes evaluated. However, to reduce the amount of buccal gingival recession, the papilla base incision presented the highest probabilities of being ranked the most effective incision (85.7%), followed by submarginal incision (50.0%) and intrasulcular incision (14.3%). CONCLUSION: Regardless of the incision design used, the periodontal parameters did not statistically differ after apical surgery. CLINICAL RELEVANCE: Periodontal parameters did not significantly change despite the incision used in apical surgery. However, based on the results of the present review, the papilla base incision seems to be the best option to reduce the amount of buccal gingival recession.

Periapical Microsurgery with an Endoscope and Microscope of Two Upper Central Incisors Already Subjected to Periapical Surgery 25 Years Ago.

INTRODUCTION: The present clinical case describes periapical microsurgery with an endoscope and microscope in a patient already treated 25 years ago due to persistent periapical disease of the two central upper incisors, restored with poorly adapted crowns. Clinical Case. The first periapical surgery had been performed with silver amalgam as a retrograde filler material, causing grayish staining of the buccal mucosa. Periapical surgery was performed raising a submarginal flap with ostectomy and apicoectomy, retrograde cavity preparation with ultrasound tips, and filling with mineral trioxide aggregate (MTA). After soft tissue healing and complete bone regeneration of the lesion, retreatment of the incisors with a fixed prosthesis was carried out, adopting the biologically oriented preparation technique (BOPT). CONCLUSIONS: The described periapical microsurgery approach with magnification and illumination of the surgical field was found to be effective, avoiding the need to extract the two central upper incisors.

Influence of operator's professional experience in the postoperative course after surgical extrac-tion of the impacted lower third molar: A pilot study.

BACKGROUND: Third molars are present in 96.6% of humans, although they do not always erupt completely. Between 9.5% and 73% of them remain impacted. Surgical removal of impacted third molars is the most common practice in oral and maxillofacial surgery. This procedure results in traumatism and, consequently, the postoperative phase will involve symptomatology. It is uncommon to find studies that directly relate postoperative symptomatology and the operator's experience. The aim of this study was to determine the differences regarding postoperative symp-tomatology in patients undergoing the bilateral extraction of lower impacted third molars and according to the operator's experience. MATERIAL AND METHODS: A prospective cohort double-blind study was conducted in 50 healthy patients (100 molar extractions) to whom both lower third molars were removed by two dentists with different degree of professional experience. The extractions were randomly assigned with a split-mouth design. If an operator extracted the lower third molar on one side, the other operator extracted the contralateral one. The variables studied after four days of postoperative period were Pain (EVA scale), Inflammation and Trismus, in addition to intraoperative time and local anesthesia administered. RESULTS: Statistically significant differences were detected in the time of intervention and in trismus, since the most experienced operator always needed less time and caused higher degree of trismus. However, this does not entail more inflammation or pain in patients, so there are no relevant differences between operators with more or less experience (p>0.05). CONCLUSIONS: The postoperative period is more favorable for the most experienced operator, although the results do not vary in a relevant manner between them. Key words:Preemptive analgesia, dental extraction, cyclooxygenases, real-time polymerase chain reaction.

Therapeutic management of the odontogenic keratocyst. An energetic approach with a conservative perspective and review of the current therapeutic options.

BACKGROUND: Odontogenic keratocysts (OKC) are cystic lesions appearing in the jaws, usually asymptomatic with a progressive growth into the bone. Many of them are diagnosed by a routine radiological examination. MATERIAL AND METHODS: This study reports a 12-year-old girl that presented an asymptomatic large radiolucent unilocular lesion associated to the crown of 3.8 that caused displacement of the molar and the inferior alveolar canal. Differential diagnosis included OKC, unicystic ameloblastoma, ameloblastic fibroma, dentigerous cyst and orthokeratinized odontogenic cyst. Two surgical interventions were performed; first, a marsupialization, and 10 months after, the third molar extraction plus cyst enucleation, mucosa excision and the application of Carnoy's solution. RESULTS: The anatomopathological exam confirmed diagnosis of OKC. There was no evidence of recurrence after 2 years of follow-up. CONCLUSIONS: Marsupialization followed by surgical enucleation with mucosa excision and Carnoy's solution can help manage treatment of OKC, a lesion characterized by an aggressive behavior. Key words:Odontogenic keratocyst, mucosa excision, carnoy solution, third molar, tooth extraction.

Effect of an Informative Video on Anxiety and Hemodynamic Parameters in Patients Requiring Mandibular Third Molar Extraction: A Randomized Clinical Trial.

PURPOSE: The purpose was to determine the effect of watching an informative video about mandibular third molar (M3M) removal on patient anxiety and hemodynamic parameters. PATIENTS AND METHODS: A randomized controlled clinical trial was carried out in healthy patients (aged between 18 and 40 years) requiring M3M extraction under local anesthesia. Patients with previous tooth extractions, psychiatric disorders, or cardiac problems or patients undergoing anxiolytic or antidepressant drug treatment were excluded. Participants were randomized into 2 groups according to whether they watched an informative video about the surgical procedure (video group) or not (control group). The primary outcome variable was the difference between groups regarding patient anxiety assessed with the State-Trait Anxiety Inventory (STAI) and the Modified Dental Anxiety Scale (MDAS). The secondary outcome variables were hemodynamic parameters recorded during different moments of the surgical procedure. Descriptive, bivariate, and multivariate analyses were performed, and a repeated-measures mixed model was generated. Statistical significance was considered for P < .05. RESULTS: Fifty patients referred for M3M extraction met the inclusion criteria. The final data analysis was based on 47 patients: 25 from the video group and 22 controls. The bivariate analysis showed the video group to have a significant decrease in anxiety as measured by the MDAS (P = .006; 95% confidence interval [CI], -4.1 to -0.7) and STAI-State (P = .003; 95% CI, -13.7 to -0.7). A significantly lower heart rate was likewise found in the video group (χ2 = 4.30, df = 1, P = .038). The linear regression analysis adjusting for the STAI-Trait also showed lower dental anxiety measured by the MDAS in the video group (P = .023; 95% CI, 0.32 to 4.14). CONCLUSIONS: Providing preoperative information through an informative video about M3M removal significantly reduces patient anxiety and heart rate during the surgical procedure.

Does Mandibular Gonial Angle Predict Difficulty of Mandibular Third Molar Removal?

PURPOSE: Predicting the difficulty of impacted mandibular third molar (IM3M) removal remains a controversial issue because many variables have been associated with increased operation time. Thus, the main objective of this study was to assess the influence of the gonial angle on the surgical difficulty of IM3M extraction. PATIENTS AND METHODS: A prospective cohort study of patients requiring IM3M removal was conducted. The gonial angle measured with a goniometer was considered the primary predictor variable. The primary outcome variable was operation time. Difficulty also was recorded by surgeons using a 100-mm visual analog scale (VAS). Postoperative complications (pain, swelling, and trismus at 48 hours and 7 days) were registered as secondary outcome variables. A descriptive bivariate statistical analysis, Pearson correlations and scatter plots, and an explanatory multiple linear regression model were performed. Significance was set at P < .05. RESULTS: The sample comprised 60 participants (17 men and 43 women) with a mean age of 25.2 years (standard deviation, 7.1 years). No significant correlations were found between the gonial angle and operation time, VAS difficulty score, and postoperative complications. Regression analysis confirmed this lack of effect of the gonial angle. The operation time was significantly affected by surgical experience (P = .016) and patient age (P = .009), whereas the 100-mm VAS difficulty score was only related to surgical experience (P = .001). CONCLUSIONS: The gonial angle is not related to the surgical difficulty of IM3M removal. Moreover, this variable is not associated with the occurrence of postoperative complications. According to the findings in this cohort, surgical experience and patient age are the only variables significantly related to increased operation time.

Regeneration of periodontal bone defects with dental pulp stem cells grafting: Systematic Review.

BACKGROUND: The main objective is to evaluate the way to graft the dental pulp stem cells (DPSC) in periodontal defects that best regenerate periodontal tissues. Numerous procedures have been done to promote periodontal regeneration. Bone grafts show good gains clinically and radiographically but histologically seem to have minimal osteoinductive capacity. Another option that exceeds conventional surgery in reducing probing depth and increasing insertion is guided tissue regeneration and tissue engineering that could be an alternative approach to help in the regeneration of living functional bone and peri-dental structures. MATERIAL AND METHODS: A search was carried out in Cochrane, PubMed-MEDLINE and Scopus databases with keywords: "dental pulp stem cells", "periodontal regeneration", "guided tissue regeneration, periodontal", "tissue regeneration", "periodontal bone defects", "periodontal tissue engineering" and "periodontal defect". Inclusion criteria were articles in English, maximum 10 years old, in which DPSC were used to regenerate a periodontal defect. Exclusion criteria were studies not published in English, case reports, case series, literature reviews, and studies in which periodontal defect was caused by dental extraction. RESULTS: Out of the 185 articles identified, 101 after excluding duplicates, of which 94 were discarded when reading the title and abstract. 7 articles were obtained for the full text reading: a case report and a case series were eliminated. The systematic review is performed with 5 animal testing studies in vivo. The DPSC sheets regenerate a greater amount of bone than the injection. If HGF (hepatocyte growth factor) is added, the maximum bone volume regenerated (69.3 ± 3.9 mm3; p<0.01) is achieved. Similar results were obtained in all carriers tested except in the controls. The periodontal ligament stem cells (PDLSC) formed more new bone, compared to DPSC (p<0.001). The presence of new cementum and periodontal ligament induced by CMLPs, was detected histologically but DPSC cannot achieve it alone. CONCLUSIONS: Cementum or PDL regeneration does not depend only on DPSC but on other unknown factors. PDLSC has better periodontal regeneration than DPSC. DPSC significantly favours the regeneration of periodontal bone tissue but has few advantages over other grafts. It is necessary to study which growth factors or matrices can enhance their capacity for periodontal regeneration. Key words:Dental pulp, stem cells, periodontal guided tissue regeneration, periodontal bone loss.

Tramadol/dexketoprofen (TRAM/DKP) compared with tramadol/paracetamol in moderate to severe acute pain: results of a randomised, double-blind, placebo and active-controlled, parallel group trial in the impacted third molar extraction pain model (DAVID study).

OBJECTIVES: To compare efficacy/safety of oral tramadol 75 mg/dexketoprofen 25 mg (TRAM/DKP) and TRAM 75 mg/paracetamol 650 mg (TRAM/paracetamol) in moderate to severe pain following surgical removal of impacted lower third molar. DESIGN: Multicentre, randomised, double-blind, placebo-controlled, phase IIIb study. PARTICIPANTS: Healthy adult patients scheduled for surgical extraction of at least one fully/partially impacted lower third molar requiring bone manipulation. 654 patients were randomised and 653 were eligible for analysis. INTERVENTIONS: Surgery was performed under local anaesthetic. No sedation was permitted. Patients rated pain intensity (PI) using an 11-Numerical Rating Scale (NRS) (0 no pain; 10 worst pain). Participants experiencing moderate/severe pain (≥4) within 4 hours of surgery were randomised (2:2:1 ratio) to a single oral dose of TRAM/DKP 75/25 mg, TRAM/paracetamol 75/650 mg or placebo. MAIN OUTCOME MEASURES: Efficacy was based patients' electronic diaries. Analgesia and pain were recorded as follows: pain relief (PAR) on a 5-point Verbal Rating Scale (0='no relief', 1='a little (perceptible) relief', 2='some (meaningful) relief', 3='lot of relief', 4='complete relief') at the predefined postdose time points t15 min, t30 min, t1 hour, t1.5 hour, t2 hour, t4 hour, t6 hour and t8 hour and PI on the 11-point NRS at t0 and at the same predefined postdose time points. Onset of analgesia documented using double stopwatch method over a 2-hour period. Primary endpoint was total pain relief over 6 hours (TOTPAR6). Rescue medication was available during the treatment period. RESULTS: TRAM/DKP was superior to TRAM/paracetamol and placebo at the primary endpoint TOTPAR6 (p<0.0001). Mean (SD) TOTPAR6 in the TRAM/DKP group was 13 (6.97), while those in the active control and placebo groups were 9.2 (7.65) and 1.9 (3.89), respectively. Superiority of TRAM/DKP over active comparator and placebo was observed at all secondary endpoints. Incidence of adverse events was comparable between active groups. CONCLUSIONS: TRAM/DKP (75/25 mg) is effective and superior to TRAM/paracetamol (75/650 mg) in relieving moderate to severe acute pain following surgical removal of impacted lower third molar, with a faster onset of action, greater and durable analgesia, together with a favourable safety profile. TRIAL REGISTRATION NUMBER: EudraCT 2015-004152-22 and NCT02777970.

Osteoradionecrosis of the jaws triggered by dental implants placement: A case report.

BACKGROUND: The decision-making process about how to rehabilitate edentulous osseous defects in patients with head and neck cancer history can be complex. Even though, endosseous dental implants could be considered to be the first choice for treating these patients, it is highly important to be aware of the complications that might occur. The aim of this report was to describe the clinical features of mandibular fracture after dental implants placement on a cancer irradiated patient and update the available information about this event. CASE REPORT: The case describes a 70-year-old man, with medical background of radiotherapy in jaw bones to treat a carcinoma in the floor of the mouth and later on in the soft palate and cheek. One week after dental implant surgery, the patient presented a mandibular osteoradionecrosis that healed in 8 months. A fracture on the right side of the body mandible was diagnosed one year after implant placement. Although several options were suggested in order to repair the fracture, the patient did not accept any further treatment despite the callus formation not being radiographically evident. The implant-supported prosthesis is functionally useful for more than 8 years of follow-up without significant problems. CONCLUSIONS: The implant treatment and management of oncologic irradiated patients require special considerations due to the risk of osteoradionecrosis and its possible complications, such as pathologic fracture. It is necessary to provide full information to the patient about risk factors and complications. Key words:Dental implants, mandibular fracture, osteoradionecrosis jaw, complications, fracture, cancer.