Localized Osteitis Research Articles

Oral Manifestations in Diabetes Mellitus and Management Considerations: A Review

Diabetes mellitus is a chronic metabolic disorder defined as an increase in sugar levels in the bloodstream brought onby either insufficient insulin secretion, resistance to insulin's effects, or both. All age groups are affected by the chronic conditionknown as diabetes mellitus. It is among the world's major causes of mortality and morbidity. Xerostomia, dental caries,periodontal disease, gingivitis, candidiasis, other oral infections, burning mouth syndrome, taste dysfunction, oral mucosalalterations, delayed wound healing, and localized osteitis are common oral manifestations of diabetes mellitus. Majorcomplications impacting a patient's quality of life include oral complications in diabetic individuals. Long-term oral problems inthese patients’ harm blood glucose regulation, making oral complications care and prevention important. The dental professionalshould be familiar with DM's oral manifestations to identify this disease complication. This article not only discusses the oralmanifestations but also discusses management considerations in diabetic patients which will help future dental professionals indental practice. This article aims to spread knowledge and awareness about the potential oral manifestations of diabetes mellitusand treatment considerations.Keywords: , , , , ,

Frequency of dry socket among patients undergoing dental extraction presenting to Ayub Teaching Hospital

BACKGROUND & OBJECTIVE: Tooth extraction is the most common procedure performed at the dental office. A very well recognized and recurrent post tooth extraction complication that dental surgeons face is Dry Socket (DO) also introduced as alveolar osteitis, localized osteitis, or simply alveolitis. The objective of this study is to ascertain the frequency of dry socket among patients undergoing dental extraction at Ayub Teaching Hospital.
 METHODOLOGY: This descriptive cross-sectional study was performed in the department of Oral and Maxillofacial Surgery, Ayub Teaching Hospital, Abbottabad for six months. A sample size of 203 patients was predetermined using WHO a calculator. Patients of either gender from 18 to 65 years were selected. Following the standard extraction technique, detailed postoperative instructions were given. The patients were educated about the symptoms of dry socket and were requested to report immediately if he/she felt any of the said symptoms. Those patients that reported dry socket, were identified, and their data was noted on structured proforma. Statistical Package for Social sciences (SPSS) version 21 was used to analyze the data obtained.
 RESULTS: The Mean age recorded in present study was 35±12.00. Gender distribution showed that 155 (76.35%) patients were male and 48 (23.64%) patients were female. Mean number of days elapsed for dry socket was 5+0.57 Frequency of dry socket recorded was 12 (05.91%) patients.
 CONLCUSION: In this study, the results collected were found to be statistically insignificant on the accounts of trends such as female preponderance and dry socket distribution posteriorly in the mandible. Our study was in accordance with the studies in literature.

Plate-associated localized osteitis in mini-pig by biofilm-forming Methicillin-resistant Staphylococcusaureus (MRSA): establishment of a novel experimental model

PurposeThe increasing number of implant-associated infections during trauma and orthopedic surgery caused by biofilm-forming Staphylococcus aureus in combination with an increasing resistance of conventional antibiotics requires new therapeutic strategies. One possibility could be testing for different therapeutic strategies with differently coated plates. Therefore, a clinically realistic model is required. The pig offers the best comparability to the human situation, thus it was chosen for this model. The present study characterizes a novel model of a standardized low-grade acute osteitis with bone defect in the femur in mini-pigs, which is stabilized by a titanium locking plate to enable further studies with various coatings.MethodsA bone defect was performed on the femur of 7 Aachen mini-pigs and infected with Methicillin-resistant S. aureus (MRSA ATCC 33592). The defect zone was stabilized with a titanium plate. After 14 days, a plate change, wound debridement and lavage were performed. Finally, after 42 days, the animals were lavaged and debrided again, followed by euthanasia. The fracture healing was evaluated radiologically and histologically.ResultsA local osteitis with radiologically visible lysis of the bone could be established. The unchanged high Colony-forming Units (CFU) in lavage, the significant differences in Interleukin (IL)-6 in blood compared to lavage and the lack of increase in Alkaline Phosphates (ALP) in serum over the entire observation period show the constant local infection.ConclusionThe study shows the successful induction of local osteitis with lysis of the bone and the lack of enzymatic activity to mineralize the bone. Therefore, this standardized mini-pig model can be used in further clinical studies, to investigate various coated implants, bone healing, biofilm formation and immune response in implant-associated osteitis.

CLINICAL AND RADIOLOGICAL FEATURES OF THE MAXILLARY SINUS IN PATIENTS AFTER REMOVAL OF FUNGAL BALL AND THEIR IMPACT ON THE FREQUENCY OF SUBANTRAL BONE AUGMENTATION COMPLICATIONS.

Abstract. The mucoperiostitis and local osteitis are radiological symptoms of the fungal ball of the maxillary sinuses. The condition of the mucoperiosteum and the adjacent bone in the alveolar bay of the maxillary sinus predict the results of dental implantation and subantral augmentation. The endoscopic access to the sinus by the antrostomy in the middle meatus and infraturbinal have been used to avoid excessive tissue injury during the removal of the fungal ball.
 Aim: To assess the condition of the bone and mucoperiosteum of the maxillary sinus in patients with fungal ball after rhinosurgery by the antrostomy with additional osteoplastic infraturbinal access.
 Methods and materials: The data of 102 patients who underwent surgery for the fungal ball of the maxillary sinus were analyzed, and subsequently - subantral bone augmentation and dental implantation were performed. In patients of the first group (67 people) - endoscopic intervention was performed by antrostomy in the middle meatus, and in 2nd group (35 people) - additional osteoplastic infraturbinal access was used.
 Result: Computed tomography data were evaluated before endoscopic sinus surgery and before subantral augmentation. The frequency of signs and severity of osteitis according to Kannedy Osteitis Score, after the intervention did not change significantly, and was established as 0.90 ± 0.07 in patients of group №1 and 0.77 ± 0.08 – group №2. The total frequency of complications with subantral augmentation in the comparison groups was 17.91 ± 4.68% and 17.14 ± 6.37%, respectively. Symptoms of osteitis in patients with fungal ball of the maxillary sinus after endoscopic removal, in the first 4 - 6 months of observation tend to regress, but do not disappear.
 Conclusions: The incidence of osteitis in computed tomography in patients with maxillary sinuses fungal balls in 4.8 months after endoscopic removal tends to decrease and is 77.61 ± 5.09% when approach through the middle meatus and 74.29 ± 7, 39% in patients with combined infraturbinal approach. The use of additional infraturbinal approach in patients with a fungal ball does not adversely affect the results of subsequent subantral augmentation and dental implantation.

Post operative complications associated with non- surgical tooth extraction

Aim: The purpose of this study was to evaluate the clinical pattern of post-extraction wound healing and determination the types, incidence, and pattern of healing complications following non-surgical tooth extraction.Materials and Methods: this study includes 156 patients, who were come for extractions of teeth. This study was carried out at specialized dental centre of AL-Thawra during the period from the beginning of May to the end of September 2007). For each patient collected information pre-operatively included age and gender of the patient, indications of extraction, and tooth/teeth removed. Extractions were performed under local anesthesia with dental forceps, elevators, or both. Patients were evaluated on the third and seventh postoperative days for alveolus healing assessmentResults: one hundred forty-one patients (141) with 159 extraction teeth were evaluated for alveolus healing. Uncomplicated healing was in 142 (89.3 %), while 17 alveoli (10.7 %) developed healing complications. These complications were: localized osteitis 13 (8.2 %); acutely infected alveolus 3 (1.9 %); and an acutely inflamed alveolus1 (0.6%). Females developed more complications than males (p=0.003). Most complications were found in molars (82.5 %) and premolars (17.5 %). Localized osteitis caused severe pain in all cases, while infected and inflamed alveolus caused mild or no pain.Conclusions: Most of the post-extraction alveoli healed uneventfully. Apart from alveolar osteitis (AO), post-extraction alveolus healing was also complicated by acutely infected alveoli and acutely inflamed alveoli. This study also demonstrated a painful alveolus is not necessarily a disturbance of post-extraction site wound healing; a thorough clinical examination must, therefore, be made to exclude any of the complications.

Effect of hyperbaric oxygen therapy (HBO) on implant-associated osteitis in a femur fracture model in mice.

Hyperbaric oxygen therapy (HBO) is applied very successfully in treatment of various diseases such as chronic wounds. It has been already suggested as adjunctive treatment option for osteitis by immune- and fracture modulating effects. This study evaluates the importance of HBO in an early implant-associated localized osteitis caused by Staphylococcus aureus (SA) compared to the standard therapy. In a standardized murine model the left femur of 120 BALB/c mice were osteotomized and fixed by a titanium locking plate. Osteitis has been induced with a defined amount of SA into the fracture gap. Debridément and lavages were progressed on day 7, 14, 28 and 56 to determine the local bacterial growth and the immune reaction. Hyperbaric oxygen (2 ATA, 90%) was applied for 90 minutes on day 7 to 21 for those mice allocated to HBO therapy. To evaluate the effect of HBO therapy the following groups were analyzed: Two sham-groups (12 mice / group) with and without HBO therapy, two osteotomy groups (24 mice / group) with plate osteosynthesis of the femur with and without HBO therapy, and two osteotomy SA infection groups (24 mice / group) with and without HBO therapy. Fracture healing was also quantified on day 7, 14, 28 and 56 by a.p. x-ray and bone healing markers from blood samples. Progression of infection was assessed by estimation of colony-forming units (CFU) and immune response was analyzed by determination of polymorphonuclear neutrophils (PMN), Interleukin (IL) - 6, and the circulating free DNA (cfDNA) in lavage samples. Osteitis induced significantly higher IL-6, cfDNA- and PMN-levels in the lavage samples (on day 7 and 14, each p < 0.05). HBO-therapy did not have a significant influence on the CFU and immune response compared to the standard therapy (each p > 0.05). At the same time HBO-therapy was associated with a delayed bone healing assessed by x-ray radiography and a higher rate of non-union until day 28. In conclusion, osteitis led to significantly higher bacterial count and infection parameters. HBO-therapy neither had a beneficial influence on local infection nor on immune response or fracture healing compared to the standard therapy in an osteitis mouse model.

Local use of antifibrinolytic agent in prevention of alveolar osteitis (A clinical study)

The study was done to evaluate the effect of local use of antifibrinolytic agent in the prevention of alveolar osteitis after extraction of impacted mandibular 3rd molar. The study took place on 90 consecutive patients (45 patients in each group). After surgical extraction the sockets were irrigated immediately with 10ml of solution (tranexamic acid or placebo) for 2 min. 4 times / day (every 6 hours) for 2 days. Patients returned in five to seven days for suture removal complaining of postoperative pain were examined to verify the severity of the localized osteitis which graded as mild, moderate, or severe according to the patient’s stated degree of pain which scored according to visual analogue scale .The incidence of dry sockets in the group treated with 10% tranexamic acid was 6.6% compared with 28.8% in the sockets treated with placebo. In addition, the untreated group presented with dry sockets judged to be more severe.

Oral Contraceptives and Oral Health:An Insight

Oral contraceptive pills are a safe and effective means of avoiding pregnancy followed by women worldwide. These drugs were first introduced in 1960s and 70s and contained higher dose of estrogen and progesterone and were reported to cause unwanted side effects like gingival inflammation, localized osteitis, alterations in salivary flow rate, changes in salivary components and gingival melanosis in oral tissues. With the advent of new generation formulations of low dose oral contraceptive pills, the effects on oral health is minimized and presently users are not considered as risk group for developing gingival and periodontal disease. This review briefs the effects of oral contraceptive pills on general health and oral health in particular and controversies surrounding their use.

Evaluation of Postoperative Complications after Surgical Removal of Impacted Lower Wisdom Teeth: a Prospective Study

The removal of third molars is the most common procedure in oral surgery. It may be associated with minor complications such as pain, dry socket, infection, and major complications such as sensory disturbances and iatrogenic damage to the 2nd molar or mandibular fractures. Aim: The aim of this study was to evaluate the incidence of various complications, including pain, alveolitis, infection and damage to the inferior alveolar and lingual nerve that may occur during or after surgical removal of impacted mandibular third molars. Materials and methods: This prospective study took place between March 1st, 2013 and January 29th, 2014 and it was done by the author. The sample consisted of 152 patients (90 males and 62 females with an age range of 20 – 45 years). The patients underwent surgical removal of a completely or partially impacted lower wisdom tooth. All impacted third molars in the study were asymptomatic at the time of surgery. A standardized case sheet was filled for each patient and the patients were informed to register the pain and any other complications in these sheets. Results: The overall complication rate was 35 patients (23.02%). Twenty-three (15%) patients developed moderate to severe pain, immediately after the operation lasting till the 3rd or 4th day postoperatively. Five patients (3.42%) developed localized osteitis, four patients (2.73%) developed postoperative oozing that lasted for 5 days, and three cases (1.97%) developed postoperative infection. None of the patients developed postoperative lingual nerve or inferior alveolar nerve dysfunction. Conclusion: Postoperative pain is the main complication after surgical removal of impacted lower wisdom teeth and alveolar osteitis is the second most important complication. Inferior alveolar nerve, lingual nerve damage and bleeding are very rare complications. The complications can be minimized by careful surgical extraction, postoperative medication and following postoperative instructions.

Antibiotic prophylaxis for third molar extraction in healthy patients: Current scientific evidence.

Third molar extraction is one of the most frequently performed procedures in the dental clinic, and it is associated with innumerable trans- and postoperative complications, such as pain, trismus, edema, localized alveolar osteitis, and surgical site infection. Some authors advocate the use of local or systemic antibiotics to reduce the incidence of these postoperative complications. However, several studies have revealed an insignificant gain after using antibiotics. Despite the risks of allergic reactions, toxicity, and the development of resistant microorganisms, about 50% of dentists routinely prescribe the use of prophylactic antibiotics for this purpose. The goal of this paper is to evaluate the scientific evidence that justifies antibiotic prescription to healthy patients undergoing third molar extraction.

Late Pleistocene foot infection in Dama mesopotamica from Tabun B (Mount Carmel, Israel)

Tabun is one of the most important Palaeolithic sites in the near East, with levels dating from the Lower through to the Upper Palaeolithic. The faunal collection from Tabun Cave (Israel) was recovered by Dorothy Garrod during archaeological excavations carried out during the 1920–30s in Mount Carmel. Since then this collection has been housed at The Natural History Museum, London. In this brief communication, a frequently occurring pathology in the phalanges of fallow deer (Dama mesopotamica) from Level B is reported. The pathology consists of bone resorption on the cortex of the axial surface of the proximal phalanges, most likely as a result of a localized osteitis produced by an infection, initially on the hoof, and later on the phalanges and even metapodials. These pathologies were probably caused by bacterial infection, possibly linked to environmental and climatic conditions at the site.

Implant‐associated localized osteitis in murine femur fracture by biofilm forming Staphylococcus aureus: A novel experimental model

Staphylococcus aureus (SA) is the most common causative agent for implant-associated osteitis. The present study characterizes a novel model of a low grade acute SA osteitis with bone defect in the femur which is stabilized by a titanium locking plate. Wild-type Balb/c mice were osteotomized, fixed by a locking plate and infected with SA. Mice underwent debridement 7 and 14 days later and were sacrificed at Day 28. At Days 7, 14, and 28 after inoculation local and systemic cell populations and IL-6 were analyzed. Fracture healing was quantified by radiography. The control group underwent the same procedure without infection. The bacterial load of implant-associated osteitis with biofilm formation was quantified by counting CFU and real-time PCR. Fracture healing determined by radiography was delayed in infected compared to non-infected mice. Throughout the investigation period CFU and leukocyte counts, as well as IL-6 levels were found to be significantly elevated in infected mice at the infection site but not systemically. Our murine model allows the detailed investigation of implant associated localized osteitis with biofilm producing SA and its influence on fracture healing. The model provides a tool to analyze therapeutic or prophylactic approaches to the problem of biofilm-associated osteitis.

Prevention of localized osteitis in mandibular third-molar sites using platelet-rich fibrin.

Purpose. To review our experience utilizing platelet rich fibrin (PRF), which is reported to aid in wound healing of extraction sites, for the prevention of localized osteitis following lower third-molar removal. Materials and Methods. PRF was placed in the mandibular third-molar extraction sites, 200 sites total, on 100 consecutive patients treated in our practice, by the authors. The patients were managed with standard surgical techniques, intraoperative IV antibiotic/steroid coverage, and routine postoperative narcotic analgesics/short-term steroid coverage. All patients were reevaluated for localized osteitis within 7–10 days of the surgery. A comparison group consisted of 100 consecutive patients who underwent bilateral removal of indicated mandibular wisdom teeth and did not receive PRF placement within the lower third molar surgical sites. Results. The incidence of localized osteitis (LO) following removal of 200 lower third molars with simultaneous PRF placement within the extraction site was 1% (2 sites out of 200). The group of patients whose mandibular 3rd molar sockets were not treated with PRF demonstrated a 9.5% (19 sites out of 200) incidence of localized osteitis. The latter group also required 6.5 hours of additional clinical time to manage LO than the study group who received PRF. Conclusions. This retrospective review demonstrated that preventative treatment of localized osteitis can be accomplished using a low cost, autogenous, soluble, biologic material, PRF, that PRF enhanced third-molar socket healing/clot retention and greatly decreased the clinical time required for postoperative management of LO.

Stan Scheller: The Forerunner of Clinical Studies on Using Propolis for Poor and Chronic Nonhealing Wounds

For hundreds of years poor and chronic nonhealing wounds have constituted a serious problem to medicine. What is more, treating such wounds is an expensive let alone a long-lasting process. The following paper describes Professor Scheller's achievements in using propolis for poor and chronic non-healing wounds. The authors' intention was to present the results connected with the use of the ethanolic extract propolis, in the treatment of patients suffering from burns, venous crural ulceration, local sacral bone pressure ulcers, suppurative osteitis and arthritis, suppurative postoperative local wound complications, and infected traumatic wounds.

Smoking and Localized Osteitis

We read with interest the article entitled “Factors Affecting Incidence of Dry Socket: A Prospective Community-Based Study” by Parthasarathi et al1 in the July 2011 issue of the journal, which referenced 2 of our publications from studies performed at the National Institutes of Health. Both of our articles reported on the findings of smoking in relation to postoperative localized osteitis (LO).

Reply by the Authors

We thank Drs Sweet and Butler for their comments regarding our study and their contribution to the current knowledge on alveolar osteitis. Smoking and Localized OsteitisJournal of Oral and Maxillofacial SurgeryVol. 69Issue 12PreviewWe read with interest the article entitled “Factors Affecting Incidence of Dry Socket: A Prospective Community-Based Study” by Parthasarathi et al1 in the July 2011 issue of the journal, which referenced 2 of our publications from studies performed at the National Institutes of Health. Both of our articles reported on the findings of smoking in relation to postoperative localized osteitis (LO). Full-Text PDF

Meningococcal purpura fulminans in children: I. Initial orthopedic management

Purpura fulminans is a rare and extremely severe infection, mostly due to Neisseria meningitidis frequently causing early orthopedic lesions. Few studies have reported on the initial surgical management of acute purpura fulminans. The aim of this study is to look at the predictive factors in orthopedic outcome in light of the initial surgical management in children surviving initial resuscitation. Nineteen patients referred to our institution between 1987 and 2005 were taken care of at the very beginning of the purpura fulminans. All cases were retrospectively reviewed so as to collect information on the total skin necrosis, vascular insufficiency, gangrene, and total duration of vasopressive treatment. All patients had multiorgan failure; only one never developed any skin necrosis or ischemia. Eighteen patients lost tissue, leading to 22 skin grafts, including two total skin grafts. There was only one graft failure. Thirteen patients were concerned by an amputation, representing, in total, 54 fingers, 36 toes, two transmetatarsal, and ten transtibial below-knee amputations, with a mean delay of 4weeks after onset of the disease. Necrosis seems to affect mainly the lower limbs, but there is no predictive factor that impacted on the orthopedic outcome. We did not perform any fasciotomy or compartment pressure measurement to avoid non-perfusion worsening; nonetheless, our outcome in this series is comparable to existing series in the literature. V.A.C.(®) therapy could be promising regarding the management of skin necrosis in this particular context. While suffering from general multiorgan failure, great care should be observed not to miss any additional osseous or articular infection, as some patients also develop local osteitis and osteomyelitis that are often not diagnosed. We do not advocate very early surgery during the acute phase of purpura fulminans, as it does not change the orthopedic outcome in these children. By performing amputations and skin coverage some time after the acute phase, we obtained similar results to those found in the literature.

Do Single-Photon Emission Computerized Tomography Findings Predict Severity of Chronic Rhinosinusitis: A Pilot Study

Chronic rhinosinusitis (CRS) is basically an inflammatory disease of the mucosa and periosteum of the sinuses. The possibility of local osteitis can cause persistent mucosal inflammation and lead to failure of treatment. Bone scintigraphy is the gold standard procedure for detecting the bone involvement. This study was designed to evaluate whether single-photon emission computerized tomography (SPECT) findings predict severity of chronic sinusitis and subjective response to medical treatment. A prospective case control study was done. Twenty-four patients with CRS were involved. SPECT findings for bone involvement and computed tomography-based staging (limited disease, stage 1; extensive disease, stages 2 and 3) were compared. These data were also analyzed in terms of subjective response to medical treatment and prognosis. SPECT uptakes were positive in 79.2% (19/24) and negative in 20.8% (5/24) of the patients. SPECT was positive in 4/8 of the patients with limited disease and 15/16 of the patients with extensive disease. In subjective assessment of medical treatment 5/8 of the limited disease versus 1/16 the extensive disease patients had good response; whereas 5/5 of SPECT(-) patients versus 1/19 of SPECT(+) patients had good response. Bone SPECT results were found to be correlated with the stage of CRS. Poorer subjective response was observed in patients with positive SPECT.

The Incidence of Concurrent Osteitis in Patients with Chronic Rhinosinusitis: A Clinicopathological Study

The pathogenesis of chronic rhinosinusitis (CRS) has been found to be multifactorial, with environmental, general host, and local anatomic factors all contributing to its development. Recent studies have indicated that local osteitis of the underlying bone also may play a critical role in the elaboration of CRS by inducing persistent inflammatory changes in the surrounding mucosa. The purpose of this study was to determine the clinical incidence rate of osteitis in patients with CRS undergoing functional endoscopic sinus surgery. From January to July 2003, a prospective study was performed on 121 patients undergoing functional endoscopic sinus surgery for CRS. Age, number of previous surgeries, radiographic bony characteristics, and pathological findings were all documented. The presence of concurrent osteitis was assessed using both radiographic (neoosteogenesis) and pathological (bony remodeling) criteria. The mean age of the patients was 44.3 years. Fifty-eight percent of the cases were revision surgeries, with each patient having an average of 2.2 operative procedures in the past. Computed tomography (CT) showed neoosteogenesis in 36% of patients, and 53% showed pathological evidence of osteitis on histological analysis of surgical specimens. Concurrent osteitis can be found in 36-53% of patients with CRS, using both radiographic and pathological criteria, respectively. Although a causal relationship between osteitis and CRS can not be inferred from this data, these clinical findings correlate well with previous evidence of bone involvement in CRS found in animal models, further reaffirming the association between underlying osteitis and the pathogenesis of CRS.

Clinical Evaluation of Post-Extraction Site Wound Healing

The aim of this prospective study was to evaluate the clinical pattern of post-extraction wound healing with a view to identify the types, incidence, and pattern of healing complications following non-surgical tooth extraction. A total of 311 patients, who were referred for non-surgical (intra-alveolar) extractions, were included in the study. The relevant pre-operative information recorded for each patient included age and gender of the patient, indications for extraction, and tooth/teeth removed. Extractions were performed under local anesthesia with dental forceps, elevators, or both. Patients were evaluated on the third and seventh postoperative days for alveolus healing assessment. Data recorded were: biodata, day of presentation for alveolus healing assessment, day of onset of any symptoms, body temperature (degrees C) in cases of alveolus infection, and presence or absence of pain. Two hundred eighty-two patients (282) with 318 extraction sites were evaluated for alveolus healing. Healing was uneventful in 283 alveoli (89%), while 35 alveoli (11%) developed healing complications. These complications were: localized osteitis 26 (8.2%); acutely infected alveolus 5 (1.6%); and an acutely inflamed alveolus 4 (1.2%). Females developed more complications than males (p=0.003). Most complications were found in molars (60%) and premolars (37.1%). Localized osteitis caused severe pain in all cases, while infected and inflamed alveolus caused mild or no pain. Thirty patients (12%) among those without healing complications experienced mild pain. Most of the post-extraction alveoli healed uneventfully. Apart from alveolar osteitis (AO), post-extraction alveolus healing was also complicated by acutely infected alveoli and acutely inflamed alveoli. This study also demonstrated a painful alveolus is not necessarily a disturbance of post-extraction site wound healing; a thorough clinical examination must, therefore, be made to exclude any of the complications.