Emergency treatment in teeth with symptomatic apical periodontitis a randomized clinical study Running title: Emergency treatment in teeth with symptomatic apical periodontitis Märta Stenberg Handledare: Eva Wolf Examensarbete (30hp) Malmö högskola Tandläkarprogrammet Odontologiska fakulteten Mars, 2013 205 06 Malmö Abstract The aim was to compare the pain relieving effect of complete chemo mechanical disinfection of the root canal system with removal of necrotic tissue in the pulp chamber without instrumentation of the root canals as emergency treatment in teeth with symptomatic apical periodontitis. The material consisted of 16 patients collected at the emergency clinic at Malmö University. Patients with swelling and/or systemic involvement were excluded. The patients were randomized to either treatment. The preoperative pain level and intake of analgesics was registered. Three till 5 days postoperatively the patients were contacted and asked to grade the current pain level and intake of analgesics and/or antibiotics. The results showed that 100% of the patients treated with complete chemo mechanical disinfection of the root canal system obtained satisfying pain relief compared to 71% for patients treated with removal of necrotic tissue in the pulp chamber. 44% of the patients treated with chemo mechanical disinfection of the root canal system had some kind of analgesics post-operatively compared to 29% for those treated with removal of necrotic tissue in the pulp chamber. No patients in either group reported use of antibiotics postoperatively. The conclusion was that both complete chemo mechanical disinfection and removal of necrotic tissue implied a significant pain relief as emergency treatment in teeth with symptomatic apical periodontitis. There was no difference between the two treatments concerning the number of patients who obtained sufficient pain relief or in pain relieving effect. 2 Keywords: symptomatic apical periodontitis, endodontic emergency treatment, infection, necrotic, Numeric Rating Scale, pain relief Sammanfattning Syftet med denna masterstudie var att jämföra den smärtlindrande effekten av fullständig utrensning och desinfektion av rotkanalsystemet med enbart utrymning av pulpakavum, utan instrumentering av rotkanalerna, som akutbehandling hos tänder med symtomatisk apikal parodontit. Materialet utgjordes av 16 patienter insamlade på Tandvårdshögskolans jourmottagning. Patienter med svullnad och allmänpåverkan exkluderades. Patienterna valdes slumpmässigt ut till att genomgå någon av behandlingarna. Den preoperativa smärtnivån och ev. analgetikaintag registrerades. Tre till fem dagar efter utförd behandling kontaktades patienterna per telefon och fick då gradera sin postoperativa smärtnivå samt analgetika- och/eller antibiotikaintag. Resultatet visade att 100% av patienterna som behandlades med fullständig utrensning erhöll tillfredställande smärtlindring jämfört med 71% av de patienter som behandlades med enbart utrymning av pulpakavum. Skillnaden var inte statistiskt signifikant. 44% av patienterna som behandlades med fullständig utrensning hade tagit smärtstillande postoperativt medan 29% av patienterna i utrymningsgruppen hade gjort det. Skillnaden var inte signifikant. Ingen av patienterna oavsett behandling hade tagit antibiotika efter behandlingen. 3 Ingen skillnad förelåg i andelen patienter som blev tillräckligt smärtlindrade mellan fullständig utrensning och enbart utrymning av pulpakavum hos tänder med symtomatisk apikal parodontit. Det var inte heller någon skillnad i smärtsänkning mellan de två behandlingarna. 4 Background The vital condition of the pulp is at risk as a result of micro-organisms and their toxins. They can reach the pulp, most commonly through dental caries, but also by fractures of the dental hard tissues and/or leaking restorations. The early response of the pulp is an inflammation that eventually will lead to necrosis of the pulp (1). A necrotic pulp offers a favorable environment for bacteria and allows them to aggregate and form resistant biofilms (2). Although the oral microflora consists of more than 300 bacterial species, only few of them are able to infect the necrotic pulp and survive (3). Apical periodontitis is the inflammatory response in the periapical tissues against a bacterial infection situated in the root canals of a tooth and may also induce a destruction of the surrounding bone. A study performed on monkeys showed that bone lesion could only develop when an infection was present in the necrotic tooth and not when the tooth was necrotic but non infected (4). Acute pain from a vital or necrotic tooth is a frequent occurrence in the endodontic practice (5). Often the available time to perform the treatment is limited due to an already fully booked calendar and so the purpose of the emergency treatment in these patients is to reduce the pain to an acceptable level as efficient as possible. A number of studies have been made to find the best and most cost effective emergency treatment options for acute symptoms rising from vital and necrotic teeth. This includes removal of the inflamed or necrotic tissue in the pulp chamber, complete chemo mechanical disinfection of the root canal system and systemic antibiotic treatment alone or in combination with other treatments (6-8). A range of studies have shown good result for pulpotomy as emergency treatment in symptomatic vital teeth with approximately 90% of the treated 5 patients obtaining pain relief post-operatively. The pain relief was measured as completely free of symptoms, mild post-operative pain or low return frequency for additional treatment in the different studies made on this topic (9-13). This result is comparable with those of complete chemo mechanical disinfection of the root canal system in vital teeth, but pulpotomy can be seen as a more cost effective option at the acute situation because of a shorter treatment time needed (11, 13-14). Systemic antibiotic as symptomatic treatment in vital teeth is considered non-adequate. This is due to that the infection is located in the hard tissues of the tooth (dental caries) and so antibiotics can't reach it to with the blood stream to eliminate it (15). However, systemic antibiotic treatment alone has been found to have a pain relieving effect in patients with a symptomatic necrotic tooth (6), while antibiotics as additional treatment to complete chemo mechanical disinfection of the root canal system was found to have no additional effect on pain relief (7-8). Considering removal of necrotic tissue in the pulp chamber, Molander et al. (2004)(12), showed in a prospective study with 76 patients that the pain relief in necrotic teeth was considered sufficient in approximately 75% of the patients. In a retrospective study with 2184 patients, Bjerkén et al. (1980)(13) found a return frequency of 25% within 10 days in patients treated with only removal of necrotic tissue in the pulp chamber, compared to a 9% return frequency among patients receiving a complete disinfection of the root canal system at the emergency treatment occasion. Other studies showed that 73-89% of patients treated with complete chemo mechanical disinfection obtained pain relief post-operatively. Many of them required though a post- operative intake of peripheral analgesics (7-8, 16). 6 Very few studies can be found which investigate emergency treatment in necrotic teeth and no randomized controlled clinical study could be found in which the pain relieving effect of a complete chemo mechanical disinfection of the root canal system is compared to the removal of necrotic tissue in the pulp chamber but without instrumentation of the root canals. The aim of this prospective, randomized clinical study was to compare complete chemo mechanical disinfection of the root canal system with removal of necrotic tissue in the pulp chamber but without instrumentation of the root canals as emergency treatment in teeth with symptomatic apical periodontitis, with the outcome measure pain relief. The expected result and hypothesis was to find that the root canal infection as the etiological factor of the experienced pain must be completely eliminated by complete chemo mechanical disinfection in order to achieve a satisfying pain relief in a majority of patients. Material and methods Subjects The study included consecutive adult patients attending the emergency clinic at the Faculty of Odontology, Malmö University, Malmö, Sweden during March-October 2012, where they were clinically diagnosed with a symptomatic apical periodontitis. The patients reported spontaneous pain and/or pain on percussion and palpation of the area. The patients graded their pain from 0-10 on the Numeric Rating Scale (NRS), and those who graded their pain with NRS >3 were included in the study. Included patients were also required to have the possibility to return to the clinic within two weeks and accepted to be contacted by phone within 3-5 days after the emergency treatment. 7 Those patients where the current tooth had received previous endodontic treatment and those where additional treatment with antibiotics or incision would be needed were excluded. Indications for antibiotics and/or incision were intra- and/or extra oral swelling and fever as an indicator of systemic involvement. Treatment The examinations and the following treatments were executed by general or specialized dentists or by supervised undergraduate students at the emergency clinic. The patients were randomized using a randomization chart made in Microsoft Office Excel 2007 with numbers from 1-1000, to be treated either by removal of necrotic tissue in the pulp chamber (odd numbers) but without instrumentation of the root canals (RNT) or by complete chemo mechanical disinfection (even numbers) of the root canal system (CMD). Excavation of present caries was made in all the symptomatic teeth when necessary and an access preparation was made with the purpose to expose all root canal entrances. The RNT treatment was performed without the use of rubber dam and the pulp chamber was cleaned from necrotic and infected tissue with the rinse of non sterile water. The patients were scheduled for a new appointment within two weeks after the treatment for complete chemo mechanical disinfection of the tooth. The CMD treatment was performed with the use of rubber dam. The working area had to be well isolated without leakage from the oral cavity. The tooth and the rubber dam clamp were disinfected with a 30% solution of hydrogen peroxide (APL, ApotekProduktion&Laboratorier AB) while the entire field of operation including tooth, clamp and rubberdam was disinfected with a 0,5% chlorhexidine-alcohol (Fresenius Kabi). The root canals were cleaned and shaped using the crown-down concept with K3 rotary instrumentation (Dentsply, DeTrey GmbH, 8 Konstanz, Germany) and/or manual instruments following the ISO-standardization, till adequate size where necrotic tissue as well as infected dentin was removed, depending on the size of the root canal. The chemical rinse consisted of an irrigation with 0,5% buffered NaOCl solution(Dakin’s solution) and a 15% ethylenediaminetetraacetic acid (EDTA) solution (APL, ApotekProduktion&Laboratorier AB). Calcium hydroxide was the temporary dressing in the root canals. After the treatment, all the teeth were sealed with a temporary filling of zinc oxide-eugenol cement (ZOE) and a glass ionomer cement( Ketac™ Fil, 3M ESPE Dental Products, Germany). All patients were contacted by phone 3-5 days after the emergency treatment and were reminded of their pre-operative grading on NRS and were then asked to grade their current post-operative pain according to NRS. Patients with NRS ≤ 3 post-operatively were considered satisfying pain relieved. Their possible post-operative use of analgesics and antibiotics was registered. Power analysis A statistical power analysis was conducted using parts of the data from one study (Bjerkén et al. 1980) (13) that had evaluated both complete chemo mechanical disinfection and removal of necrotic tissue in the pulp chamber. With two groups, each consisting of 95 test subjects, the chances of obtaining a statistically significant result is 80%, if there is a difference of 16,5% (90,5% vs 74%) between the groups. Statistics For the calculations the Predictive Analytic SoftWare (PASW) Statistics 18 was used. The statistical method of 2x2 tables was the Chi square test or Fisher's exact test when the proportions were small and the expected value < 5. The calculations were two-tailed. Results were considered statistical significant at p < 0.05. 9 Ethical considerations An ethical consideration concerning leaving necrotic and infected tissue in a tooth was made. By informing the patients about possible consequences, giving them a new appointment for removal of the necrotic tissue, this was considered enough to keep the patient's state under control. Patients were also welcome to contact the clinic for additional treatment if needed before scheduled appointment. The study was approved by the Local Ethical Review Board at the Faculty of Odontology, Malmö University, Malmö Sweden according to the World Medical Association (WMA) Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects (17). The patients also signed an informed consent before they participated in the study. Results There were 19 patients included in the study. Three patients were drop-outs, two women and one man between 46 and 75 years old with the average age of 59.3 years old. The cause was non-accessible and/or narrow root canals and so the pre-determined treatment was not possible to execute at the first treatment occasion. There were nine patients treated in the CMD group and seven patients in the RNT group. Five of the patients were men, 11 were women. The patients were between 23 and 88 years of age. The average age of the treated patients was 48.5 years. Dental students performed the treatment in four patients in the CMD group and in four patients in the RNT group while dentists performed the treatment in five patients in the CMD group and in three patients in the RNT group. 10
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