Plain language summary
The effects of antibiotics on toothache caused by inflammation or infection at the root of the tooth in adults
This review, carried out by authors of the Cochrane Oral Health Group, has been produced to assess the effects of antibiotics on pain and swelling in two conditions commonly responsible for causing dental pain when given with or without dental treatment (such as extraction, drainage of a swelling or root canal treatment).
Dental pain is a common problem and can arise when the nerve within a tooth dies due to progressing decay or severe trauma. The tissue around the end of the root then becomes inflamed and this can lead to acute pain, which gets worse on biting. Without treatment, bacteria can infect the dead tooth and cause a dental abscess, which can lead to swelling and spreading infection that may be life threatening.
The recommended treatment of this form of toothache is the removal the dead nerve and associated bacteria. This is usually done by dental extraction or root canal treatment. Antibiotics should only be prescribed when there is severe infection that has spread from the tooth. However, some dentists still routinely prescribe oral antibiotics to people with acute dental conditions that have no signs of spreading infection.
Minimising inappropriate antibiotic prescribing is plays a key role in limiting the development of antibiotic-resistant bacteria. Since dentists prescribe approximately 8% to 10% of all primary care antibiotics in developed countries, dental prescribing may contribute to antibiotic resistance. Therefore, it is important that antibiotics should only be used when they are clinically beneficial for the person.
The evidence on which this review is based was up to date as of 1 October 2013. We searched scientific databases and found two trials, with a 62 participants included in the analysis. Both trials were conducted at university dental schools in the USA and evaluated the use of oral antibiotics in the reduction of pain and swelling reported by adults after having the first stage of root canal treatment under local anaesthetic. The antibiotic used in both trials was penicillin VK and all participants also received painkillers.
The two studies included in the review reported that there were no clear differences in the pain or swelling reported by participants who received oral antibiotics compared with a placebo (a dummy treatment) when provided in conjunction with the first stage of root canal treatment and painkillers, but the studies were small and we could not exclude potentially important differences between groups. Neither study examined the effect of antibiotics delivered by themselves, without dental treatment.
One trial reported side effects among participants: one person who received the placebo medication had diarrhoea and one person who received antibiotics experienced tiredness and reduced energy after their operation.
Quality of evidence
We judged the quality of evidence to be very low. There is currently insufficient evidence to be able to determine the effects of antibiotics in these conditions.
Les effets des antibiotiques sur des douleurs dentaires provoquées par une inflammation ou une infection de la racine de la dent chez l'adulte
Cette revue, menée par des auteurs du groupe Cochrane sur la santé bucco-dentaire, a été produite pour évaluer les effets des antibiotiques sur la douleur et le gonflement dans deux pathologies couramment responsables de douleurs dentaires lorsqu’ils sont administrés avec ou sans traitement dentaire (tels qu'une extraction, le drainage d'un gonflement ou le traitement du canal radiculaire).
La douleur dentaire est un problème courant et peut survenir lorsque le nerf à l'intérieur de la dent meurt en raison d'une carie évolutive ou d’un traumatisme grave. Les tissus autour de l'extrémité de la racine deviennent alors inflammés et cela peut provoquer une douleur aiguë, qui s’aggrave lors de la mastication. Sans traitement, des bactéries peuvent infecter la dent morte et entraîner un abcès dentaire, ce qui peut conduire à un gonflement et à la propagation de l'infection, qui peut être mortelle.
Le traitement recommandé de cette forme de douleurs dentaires est l'ablation du nerf mort et des bactéries associées. Ceci est généralement réalisé par l'extraction dentaire ou un traitement du canal radiculaire. Les antibiotiques ne devraient être prescrits que dans le cas d’une infection grave qui se serait propagée à partir de la dent. Cependant, certains dentistes prescrivent encore systématiquement des antibiotiques oraux aux personnes atteintes de pathologies dentaires aiguës qui ne présentent aucun signe de propagation de l'infection.
La minimisation de la prescription inappropriée d'antibiotiques joue un rôle essentiel pour limiter le développement de bactéries résistantes aux antibiotiques. Étant donné que les dentistes prescrivent environ 8 % à 10 % de tous les antibiotiques prescrits en soins primaires dans les pays développés, la prescription dentaire peut contribuer à la résistance aux antibiotiques. Par conséquent, il est important que les antibiotiques ne soient utilisés que lorsqu'ils sont cliniquement bénéfiques pour la personne.
Caractéristiques des études
Les preuves sur lesquelles cette revue repose étaient à jour au 1er octobre 2013. Nous avons effectué des recherches dans les bases de données scientifiques et avons trouvé deux essais, avec 62 participants inclus dans l'analyse. Les deux essais ont été réalisés dans des écoles dentaires universitaires aux États-Unis et ont évalué l'utilisation d'antibiotiques oraux dans la réduction de la douleur et du gonflement rapportés par les adultes après avoir subi la première phase du traitement du canal radiculaire sous anesthésie locale. L'antibiotique utilisé dans les deux essais était la pénicilline VK et tous les participants avaient également reçu des analgésiques.
Les deux études incluses dans la revue ont indiqué qu'il n'y avait aucune différence claire dans la douleur ou le gonflement rapportés par les participants qui avaient reçu des antibiotiques par voie orale par rapport à un placebo (traitement fictif) lorsque les antibiotiques étaient utilisés en conjonction avec la première phase du traitement du canal radiculaire et les analgésiques, mais les études étaient de petite taille et nous n'avons pas pu exclure des différences potentiellement importantes entre les groupes. Aucune des deux études n'a examiné l'effet des antibiotiques administrés seuls, sans traitement dentaire.
Un essai a rapporté des effets secondaires chez les participants : une personne ayant reçu le placebo a eu une diarrhée et une personne ayant reçu des antibiotiques a ressenti de la fatigue et une baisse d'énergie après l'opération.
Qualité des preuves
Nous avons estimé que la qualité des preuves était très faible. Les preuves actuelles sont insuffisantes pour pouvoir déterminer les effets des antibiotiques dans ces conditions.
Notes de traduction
Traduit par: French Cochrane Centre 15th October, 2014
Traduction financée par: Financeurs pour le Canada : Instituts de Recherche en Santé du Canada, Ministère de la Santé et des Services Sociaux du Québec, Fonds de recherche du Québec-Santé et Institut National d'Excellence en Santé et en Services Sociaux; pour la France : Ministère en charge de la Santé
Učinak antibiotika na zubobolju uzrokovanu upalom ili infekcijom korijena zuba u odraslih
Ovaj Cochrane sustavni pregled literature procijenio je učinke antibiotika na bol i oteklinu u dva stanja koja često uzrokuju zubnu bol, bez obzira na to jesu li antibiotici primijenjeni uz liječenje zuba (kao što je vađenje zuba, odvođenje gnoja (drenaža) iz otekline ili liječenje zubnoga kanala).
Zubna bol je čest problem i može se razviti kada živac unutar zuba odumre zbog uznapredovalog karijesa ili teške ozljede. Tkivo koje se nalazi oko ruba korijena tada postaje upaljeno te može dovesti do akutne boli koja se pogoršava na zagriz. Bez liječenja bakterije mogu zaraziti mrtvi zub i uzrokovati gnojnu upalu u zubu (zubni apsces) koja uzrokuje oteklinu i širenje infekcije koja može i ugroziti život.
Preporučeno liječenje za taj oblik zubne boli jest uklanjanje mrtvoga živca i pridruženih bakterija. To se obično provodi vađenjem zuba ili liječenjem zubnog korijena. Antibiotici bi se trebali propisati jedino prilikom ozbiljne infekcije koja se proširila sa zuba. Međutim, neki stomatolozi još uvijek rutinski propisuju antibiotike koji se uzimaju na usta osobama s akutnim zubnim stanjima koji nemaju znakova širenja infekcije.
Smanjenje nepotrebnog propisivanja antibiotika važno je za ograničenje širenja bakterija otpornih na antibiotike. Stomatolozi propisuju 8% do 10% svih antibiotika u primarnoj praksi u razvijenim zemljama i tako mogu pridonijeti otpornosti bakterija na antibiotike. Stoga je iznimno važno koristiti antibiotike samo kada određenom pacijentu zaista mogu pomoći.
Dokazi na kojima se ovaj sustavni pregled temelji obuhvaćaju sve kliničke pokuse na tu temu objavljene do 1. listopada 2013. Autori su pretraživali znanstvene baze podataka i pronašli dva istraživanja s ukupno 62 ispitanika koja su uključena u analizu. Istraživanja su provedena na fakultetima dentalne medicine u SAD-u i u njima je ispitana korisnost oralnih antibiotika u smanjenju boli i oticanja u odraslih nakon prvog stadija liječenja kanala zubnog korijena u lokalnoj anesteziji. Antibiotik korišten u oba istraživanja bio je penicilin VK. Svi sudionici su također primali lijekove protiv boli.
Dvije studije uključene u ovaj sustavni pregled literature pokazale su da nema jasnih razlika u boli ili oteklini u sudionika koji su koristili oralne antibiotike u usporedbi s placebom (lažno liječenje) kada se daju istodobno s prvom fazom liječenja zubnoga kanala i s lijekovima protiv boli. Međutim, ta istraživanja su bila mala te stoga rezultate tih studija treba uzeti s oprezom. Niti jedna od te dvije studije nije ispitivala učinak samih antibiotika bez liječenja zuba.
Jedna je studija opisala nuspojave u sudionika: jedna osoba koja se liječila placebom imala je proljev, a jedna osoba koja je primala antibiotike opisala je nakon operacije umor i nedostatak energije.
Kvaliteta dokaza procijenjena je kao vrlo niska. Trenutačno nema dovoljno dokaza koji bi mogli odrediti učinke antibiotika u tim stanjima.
Prevela: Ozana Glibota
Ovaj sažetak preveden je u okviru volonterskog projekta prevođenja Cochrane sažetaka. Uključite se u projekt i pomozite nam u prevođenju brojnih preostalih Cochrane sažetaka koji su još uvijek dostupni samo na engleskom jeziku. Kontakt: email@example.com
Ringkasan bahasa mudah
Kesan antibiotik terhadap sakit gigi akibat keradangan atau jangkitan pada akar gigi dalam kalangan dewasa.
Ulasan Kumpulan Kesihatan Oral Cochrane ini bertujuan menilai kesan antibiotik terhadap sakit dan bengkak dalam dua keadaan lazim yang menyebabkan sakit gigi, akibat rawatan pergigian atau tanpa rawatan pergigian (misalnya cabutan, penyaliran bengkak atau rawatan kanal akar).
Sakit gigi adalah masalah lazim dan boleh timbul apabila saraf dalam gigi mati akibat kerosakan berterusan atau trauma yang teruk.Tisu disekeliling hujung akar mengalami keradangan dan menyebabkan sakit akut yang bertambah teruk apabila menggigit. Tanpa rawatan, bakteria boleh menjangkiti gigi yang mati dan menyebabkan abses, dan membawa kepada bengkak dan jangkitan boleh merebak dan meragut nyawa.
Rawatan yang disyorkan untuk sakit gigi seperti ini adalah pembuangan saraf yang mati dan bakteria. Ini lazim dilakukan dengan cabutan gigi atau rawatan kanal akar.Antibiotik hanya diberi apabila terdapat jangkitan teruk yang telah merebak.Namun, sesetengah doktor gigi memberi antibiotik oral secara rutin kepada pesakit yang mengalami sakit gigi akut yang tiada tanda-tanda jangkitan merebak.
Pengurangan pemberian antibiotik yang tidak wajar memain peranan utama dalam menghadkan pembentukan baktera resistan antibiotik. Oleh kerana doktor gigi memberi 8% hingga 10% dari antibiotik penjagaan primer di negara maju, preskripsi pergigian boleh menyumbang kepada rintangan antibiotik.Oleh itu, adalah penting untuk antibiotik digunakan hanya apabila terdapat manfaat klinikal untuk seseorang.
Bukti ulasan ini adalah terkini sehinga 1 Oktober 2013. Kami mencari pangkalan data saintifik dan mendapati dua kajian yang melibatkan 62 peserta untuk analisis. Kedua-dua kajian dilaksanakan di sekolah pergigian universiti Amerika Syarikat dan menilai penggunaan antibiotik oral untuk mengurangkan sakit dan bengkak yang dilaporkan oleh orang dewasa selepas peringkat pertama rawatan kanal akar dengan penggunaan anestesia setempat.Antibiotik yang diguna dalam kedua-dua kajian ialah penisilin VK dan semua peserta juga menerima ubat penahan sakit.
Kedua-dua kajian tersebut melaporkan tiada perbezaan nyata tentang sakit dan bengkak yang dilaporkan oleh peserta yang menerima antibiotik oral berbanding plasebo (rawatan semu) apabila diberi sejurus peringkat pertama rawatan kanal akar bersama ubat penahan sakit, tetapi kajian adalah kecil dan kami tidak dapat mengetepikan perbezaan kumpulan yang berpotensi penting.Kedua-dua kajian tidak menilai kesan antibiotik yang diambil sendiri tanpa rawatan pergigian.
Satu kajian melaporkan kesan sampingan dalam kalangan peserta: seorang yang menerima ubat plasebo mengalami cirit-birit dan seorang lagi yang mnerima antibiotik mengalami keletihan dan kurang tenaga selepas pembedahan.
Kami menilai kualiti bukti sebagai sangat rendah. Masa kini masih kekurangan bukti untuk menentukan kesan antibiotik dalam keadaan-keadaan tersebut.
Diterjemahkan oleh Noorliza Mastura Ismail (Kolej Perubatan Melaka-Manipal).Disunting oleh Tan May Loong,(Penang Medical College) Untuk sebarang pertanyaan mengenai terjemahan ini, sila hubungi firstname.lastname@example.org
Description of the condition
Dental pain can have a considerable detrimental effect on an individual's social functioning and quality of life (Reisine 1995; Pau 2005). In the Adult Dental Health Survey of 2009 conducted in the UK, 29% of individuals reported experiencing dental pain 'occasionally' or 'fairly/very often' during the preceding 12 months. Within the survey, prevalence of dental pain was 9%, with higher values reported for younger individuals and among lower socioeconomic groups (Steele 2011). Of these individuals, approximately 30% will be have symptomatic apical periodontitis and a further 13% will have an acute apical abscess (Sindet-Pedersen 1985; Estrela 2011).
Apical periodontitis arises following injury to the pulpal tissues of a tooth due to dental caries, tooth fracture, trauma or iatrogenic damage. While the dental pulp can recover from reversible pulpitis resulting from a mild to moderate injury, persistent or extensive damage results in irreversible levels of inflammation within the pulpal tissues. Should this occur, people may experience symptoms of irreversible pulpitis. Without treatment, irreversibly inflamed teeth then undergo pulpal necrosis and bacterial colonisation of the root canal system (Abbott 2004; Bergenholtz 2010).
Apical periodontitis (also known as periapical periodontitis) is an inflammatory lesion of the periradicular tissues that arises principally due to the egress of irritants such as bacteria and toxins from an inflamed or necrotic pulp (Torabinejad 1994). Its evolutionary role is protective: to contain the root canal bacteria and prevent the spread of infection. While the vast majority of cases are asymptomatic, exacerbations of apical periodontitis can present as symptomatic apical periodontitis or an acute apical abscess (Bergenholtz 2010).
Symptomatic apical periodontitis can arise either from a formerly healthy tooth that has subsequently undergone pulpal breakdown or from a tooth with a previously asymptomatic apical periodontitis. It is characterised by a dull or throbbing pain that is exacerbated by biting. The affected tooth usually has a negative or delayed positive response to vitality testing and is often highly sensitive to percussive forces (Bergenholtz 2010).
It should be noted that in determining the health of pulpal tissues, the term 'vitality testing' is commonly used. True 'vitality' tests attempt to examine the presence of pulp blood flow, while 'sensibility' tests employ the use of thermal or electrical stimuli to elicit a response from innervated tissue (Chen 2009). Although neither can definitively indicate the health of the dental pulp, they remain useful diagnostic aids, commonly used in both clinical practice and scientific studies.
Acute apical abscesses develop in the presence of a pre-existing apical periodontitis (Carrotte 2004). Persistent presence of infective material within the pulpless root canal system and around the apex of a tooth can lead to a massive influx of polymorphonuclear leukocytes into the periradicular tissues, leading to tissue liquefaction and pus formation (Bergenholtz 2010). Also known as a periapical, dentoalveolar or alveolar abscess, an apical abscess is characterised by the accumulation of pus in the periradicular tissues and can present as either an acute or chronic lesion. People with acute apical abscesses complain of a rapid onset, spontaneous pain, tenderness of the tooth to pressure, pus formation and swelling of associated tissues (Glickman 2009). Left untreated, the abscess may spread resulting in a serious, potentially life-threatening head and neck infection accompanied by fever, malaise and lymph node involvement (Abbott 2004). Since symptomatic apical periodontitis and acute apical abscess represent a continuum of the same disease process, it is appropriate to consider both conditions in this review (Sutherland 2004).
Description of the intervention
Clinical guidelines recommend that the first-line treatment for teeth with either symptomatic apical periodontitis or an acute apical abscess is the removal of the source of inflammation or infection by local, operative measures (Glenny 2004; SDCEP 2011). This involves either the extraction of the offending tooth, extirpation (removal) of the pulpal tissues, possibly in combination with the incision and drainage of any swelling present. Systemic antibiotics are currently only recommended for situations where there is evidence of spreading infection (cellulitis, lymph node involvement, diffuse swelling) or systemic symptoms (fever, malaise) (SDCEP 2011; Palmer 2012).
Several studies appear to indicate that antibiotics do not reduce the pain or swelling arising from teeth with symptomatic apical pathology in the absence of evidence of systemic involvement (Fouad 1996; Henry 2001). Nevertheless, 69% of individuals attending a British out-of-hours dental clinic with symptomatic apical periodontitis received a prescription for systemic antibiotics, many in the absence of a surgical intervention (Dailey 2001). Furthermore, the authors of the paper suggested that clinicians providing emergency dental treatment may be prescribing antibiotics as the first-line treatment for people with dental pain (Dailey 2001). In a survey of Spanish oral surgeons, over 70% reported that they would prescribe systemic antibiotics for people with moderate to severe pre-operative symptoms from a tooth with a necrotic pulp and acute apical periodontitis (Segura-Egea 2010). Comparatively, in a survey of members of the American Association of Endodontists, only 54% of respondents reported that they would prescribe antibiotics for the same condition, highlighting differences between practitioners of nationalities and specialities (Yingling 2002).
How the intervention might work
Doctors and dentists may prescribe systemic antibiotics to minimise the signs and symptoms of symptomatic apical periodontitis or acute apical abscess, and to treat or prevent the development of a serious orofacial swelling with systemic involvement. Antibiotics can be prescribed as an adjunctive or stand-alone treatment. People prescribed antibiotics may be given analgesics at the same time.
Why it is important to do this review
There is international concern about the overuse of antibiotics and the emergence of antibiotic-resistant bacterial strains (World Health Organization 2000). Since approximately 8% to 10% of antibiotics dispensed in primary care in developed countries are prescribed by a dentist, it is important not to underestimate the potential contribution of the dental profession to the development of antibiotic resistance (Al-Haroni 2007; Holyfield 2009; Prescribing and Primary Care Services 2013). Inappropriate use of antibiotics not only drives antibiotic resistance and misuses resources, it increases the risk of potentially fatal anaphylactic reactions and exposes people to unnecessary side effects (Gonzales 2001; Costelloe 2010). Furthermore, antibiotic prescribing for common medical problems increases patient expectations for antibiotics, leading to a vicious cycle of increased prescribing in order to meet expectations (Little 1997; Coenen 2006).
If systemic antibiotics are effective in the treatment of symptomatic apical periodontitis or acute apical abscess then it is important that the nature of any benefits be quantified. However, if antibiotics are ineffective, people may be unnecessarily exposed to harmful side effects and the increased possibility of developing antibiotic-resistant bacterial colonies. It is important that antibiotics be prescribed for dental conditions only when they are likely to result in clinical benefit for the person. Therefore, the objective of this review was to evaluate the effects of systemic antibiotics for symptomatic apical periodontitis and acute apical abscess in adults.
To evaluate the effects of systemic antibiotics provided with or without surgical intervention (such as extraction, incision and drainage of a swelling or endodontic treatment), with or without analgesics, for symptomatic apical periodontitis or acute apical abscess in adults.
Criteria for considering studies for this review
Types of studies
We included randomised controlled trials (RCTs) with parallel group design in the review. We excluded cluster RCTs.
Types of participants
Studies of adults (over the age of 18 years), male or female, who presented with a single tooth with a clinical diagnosis of either symptomatic apical periodontitis or acute apical abscess.
Types of interventions
Administration of any systemic antibiotic (either oral or intravenous) at any dosage prescribed in the symptomatic phase of apical periodontitis or acute apical abscess (with or without analgesics, and with or without surgical intervention (extraction, incision and drainage or endodontic treatment).
Administration of a matched placebo prescribed in the symptomatic phase of apical periodontitis or acute apical abscess (with or without analgesics, and with or without surgical intervention).
Types of outcome measures
Measures of participant-reported pain and swelling, gauged on either a continuous scale, such as visual analogue scale (VAS), or using binary or dichotomous outcomes.
Clinician-reported measures of infection, such as swelling, temperature, trismus (reduced mouth opening), regional lymphadenopathy or cellulitis. These outcomes may have be reported as continuous, categorical or dichotomous variables.
Participant-reported quality of life measures.
Type, dose and frequency of analgesics used.
Any adverse effects or harm (hypersensitivity or other reactions) attributed to antibiotics or analgesics, complications of surgical treatment or hospitalisations.
Search methods for identification of studies
For the identification of studies included or considered for this review, we developed a detailed search strategy for each database searched. These were based on the search strategy developed for MEDLINE but revised appropriately for each database to take account of differences in controlled vocabulary and syntax rules.
The search strategy combined the subject search with the Cochrane Highly Sensitive Search Strategy for identifying reports of RCTs (2008 revision), as published in Box 6.4.c in the Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011) (Higgins 2011). The subject search used a combination of controlled vocabulary and free text-terms based on the search strategy for searching MEDLINE. The search of EMBASE was linked to the Cochrane Oral Health Group filters for identifying RCTs.
We searched the following databases:
Cochrane Oral Health Group's Trials Register (to 1 October 2013);
Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 9);
MEDLINE via OVID (1946 to 1 October 2013);
EMBASE via OVID (1980 to 1 October 2013);
CINAHL via EBSCO (1980 to 1 October 2013).
See Appendix 1 for details of all search strategies used. All databases were searched from their inception to October 2013 and we applied no restrictions on language of publication in the electronic searches.
Searching other resources
We searched the following trials registers for ongoing studies:
World Health Organization (WHO) International Trials Registry Platform (to 1 October 2013) (www.who.int/ictrp/en/);
US National Institutes of Health Trials Registry (ClinicalTrials.gov) (to 1 October 2013).
We searched for grey literature using the following resources:
We checked the reference lists of all included and excluded studies to identify any further trials.
Data collection and analysis
Selection of studies
Two review authors (Anwen Cope (AC) and Mala Mann (MM)) independently assessed the titles and abstracts (where available) of the articles identified by the search strategy and made decisions regarding eligibility. Full-text versions were obtain for all articles being considered for inclusion, as were those with insufficient information in the title or abstract to make a clear decision. We resolved any disagreements by discussion. We excluded studies later found not to meet the inclusion criteria and recorded them in the Characteristics of excluded studiestable.
Data extraction and management
We entered study details into the Characteristics of included studies table. AC and MM independently extracted the outcome data from the included studies using a standard data extraction form. The review authors discussed the results and resolved any disagreements by discussion or with a third review author (Ivor G Chestnutt (IGC)). In cases where uncertainties persisted, we contacted the study authors for clarification.
We extracted the following characteristics of the studies.
Study methodology: study design, methods of allocation, method of randomisation, randomisation concealment, blinding, time of follow-up, loss to follow-up, country conducted in, number of centres, recruitment period and funding source.
Participants: sampling frame, diagnostic criteria, inclusion criteria, exclusion criteria, number of participants in each group, baseline group demographics and clinical diagnosis.
Intervention: type of antibiotic, dose, frequency and duration of course. Information about co-interventions, for example, surgical treatment or analgesia.
Outcomes: primary outcomes at 24, 48 and 72 hours and seven days, and secondary outcomes as previously described (seePrimary outcomes; Secondary outcomes).
Assessment of risk of bias in included studies
Two review authors (AC and MM) independently assessed the risk of bias of the included studies and resolved any disagreements by discussion with a third review author (IGC). We completed a 'Risk of bias' table for each included study following the recommended methods for assessing the risk of bias in studies included in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). This was a two-part tool addressing specific key domains including sequence generation, allocation concealment, blinding, incomplete outcome data, selective outcome reporting and other bias. We tabulated relevant information describing what happened, as reported in the study or revealed by correspondence with the study authors, for each included study, along with a judgement of low, high or unclear risk of bias for each individual domain.
A summary assessment of the risk of bias of each included study was made as follows:
low risk of bias (plausible bias unlikely to seriously alter the results) if we assessed all key domains to be at low risk of bias;
unclear risk of bias (plausible bias that raises some doubt about the results) if we assessed one or more key domains as unclear;
high risk of bias (plausible bias that seriously weakens confidence in the results) if we assessed one or more key domains to be at high risk of bias.
We completed a 'Risk of bias' table for each included study. We also presented the results graphically.
Measures of treatment effect
For dichotomous outcomes, we expressed the estimate of effect of the intervention as risk ratios (RR) together with 95% confidence intervals (CI). For continuous outcomes (such as mean VAS scores), we reported mean differences (MD) (or standardised mean differences (SMD) when different scales measuring the same concept) and their corresponding 95% CI.
Unit of analysis issues
We anticipate that, by the nature of the outcome variables being recorded, studies included in future updates may involve repeat observations. Results from more than one time point for each study cannot be combined in a standard meta-analysis without a unit-of-analysis error. Therefore, we assessed outcomes at 24, 48 and 72 hours and seven days postoperatively, as the data allowed.
We included no clustered trials in the review.
Given the nature of the conditions and intervention under review, it is high unlikely any cross-over trials will be suitable for inclusion in the future.
In updates, we will consider multi-arm studies for inclusion in the review, in accordance with recommendations in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011), we will combine all relevant experimental groups and considered them as a single group and compared them with a combined group of all the control groups, if present.
Dealing with missing data
We contacted the original investigators in cases of missing data.
Assessment of heterogeneity
We planned to assess heterogeneity using the Chi2 test (P value < 0.10 regarded as statistically significant). For studies judged as clinically homogeneous, we test heterogeneity using the I2 statistic, as recommended in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). The I2 statistic describes the percentage of variability in effect estimates that is due to heterogeneity rather than sampling error. An I2 of 0% to 40% might not be important, 30% to 60% may represent moderate heterogeneity, 50% to 90% may have substantial heterogeneity and 75% to 100% studies has substantial heterogeneity.
Assessment of reporting biases
We examined within-study selective outcome reporting as a part of the overall risk of bias assessment and contacted study authors for clarification.
If there had been at least 10 studies included in a meta-analysis, we would have assessed between-study reporting bias by creating a funnel plot of effect estimates against their standard errors. If we had found asymmetry of the funnel plot by inspection and confirmed this by statistical tests, we would have considered possible explanations and taken into account in the interpretation of the overall estimate of treatment effects.
We only carried out meta-analysis where studies of similar comparisons, reported similar outcomes, for people with similar clinical conditions. We combined MDs (or SMDs where studies had used different scales) for continuous outcomes, and combined RRs for dichotomous outcomes, using a ﬁxed-effect model if there were only two or three studies, or a random-effects model if there were four or more studies.
Subgroup analysis and investigation of heterogeneity
We planned to investigate clinical heterogeneity by examining the following subgroups should sufficient data have been available.
Different antibiotic class (e.g. penicillins versus macrolides).
The effects of accompanying surgical intervention (extraction, incision and drainage or endodontic treatment).
Provided there were sufficient studies for each outcome and intervention, we had planned to undertake sensitivity analysis based on trials judged to be of low risk of bias.
Presentation of main results
We developed a 'Summary of findings' table for the primary outcomes of this review using GRADEPro software, with the GRADE assessment of the quality of the body of evidence.
Summary of main results
The review process identified two studies suitable for inclusion, both of which assessed the effects of penicillin VK compared with a matched placebo in adults with localised apical abscess or a symptomatic necrotic tooth (no signs of spreading infection or systemic involvement) when provided in conjunction with partial or total pulpectomy conducted under local anaesthesia and analgesics. There were no statistically significant differences in primary outcomes (participant-reported pain, swelling or percussion pain or incidence of endodontic flare-up) or secondary outcomes (analgesic use or incidence of adverse events) between participants who had received antibiotics and participants who had received a matched placebo. We considered this body of evidence (two studies, one at unclear risk of bias and one at high risk of bias) to be of very low quality and it should be interpreted with caution.
We found no studies that reported the effects of systemic antibiotics versus a matched placebo for symptomatic apical periodontitis when provided in conjunction with a surgical intervention. We found no studies that reported the effects of systemic antibiotics versus a matched placebo for symptomatic apical periodontitis or acute apical abscess when provided without a surgical intervention.
Overall completeness and applicability of evidence
We employed a comprehensive search strategy and we are confident that the majority of published trials are included in this review. We made efforts to identify all relevant studies and excluded no studies due to language.
The two included trials partially addressed the first of the two objectives (Fouad 1996; Henry 2001), which both investigated the effect of systemic antibiotics for acute apical abscess or symptomatic necrotic tooth provided in conjunction with total or partial pulpectomy in adults. However, there were no trials that assessed the effects of antibiotics for symptomatic apical periodontitis when used in conjunction with a surgical intervention. Furthermore, we found no trials assessing the second objective, which sought to compare antibiotics and a placebo for symptomatic apical periodontitis or acute apical abscess when provided without a surgical intervention.
The participants included in the two trials can be considered broadly representative of people who would consult a dentist due to an acute apical abscess or symptomatic necrotic tooth who do not have evidence of spreading infection or systemic involvement - participants came from a wide age range, were about equal gender mix and the majority had moderate pain at the baseline visit. However, both the trials excluded participants with co-morbidities or who may have been immunocompromised. Therefore, the results of this review may not be generalisable to a group of people who may be at higher risk of infection. While future trials should endeavour to obtain the most representative sample possible, it is unlikely to be feasible or ethical to conduct placebo-controlled trials in these groups of people.
One trial excluded participants with signs of spreading infection and systemic involvement (Fouad 1996), and the other trial included only a small number of participants with evidence of severe infections at baseline (Henry 2001). Therefore, the results of this review may or may not be generalisable to people with severe swelling or other signs of spreading infection or systemic involvement.
Both of the included studies were conducted at university dental schools and, in both trials, endodontic treatment was completed by practitioners who either worked in the Department of Endodontics (Fouad 1996), or were senior endodontic graduate students (Henry 2001). It would be reasonable to consider that both groups of practitioners had endodontic skills in excess of those of an average primary care dentist. The specialist settings in which the trials were conducted were unlikely to face the time constraints encountered in routine clinical practice. Therefore, the intervention provided within these studies may only have limited applicability to the treatment routinely provided at emergency appointments in general dental practice, where treatment decisions are often dictated by time pressures (Palmer 2000). Therefore, more trials in a primary care setting would enhance the evidence base for answering the questions posed by this review.
We found no trials assessing the effect of other surgical interventions, such as dental extraction or incision and drainage of a swelling. Since dental extraction is a common treatment for both symptomatic apical periodontitis and acute apical abscess, and incision and drainage of acute apical abscess is also frequently undertaken, the effects of these interventions could be considered in future trials.
The outcomes reported by the two trials measured the harms as well as the benefits of interventions. This is important as antibiotics can have adverse effects such as hypersensitivity reactions and gastrointestinal upset. Many of the outcome measures in the two included trials were participant-centred, such as pain, percussion pain and swelling. Since both pain and discomfort are known to impact an individual's quality of life (Skevington 1998), future trials should also consider formally measuring oral health-related quality of life outcomes to assess the beneficial and harmful effects of this intervention in more detail.
Quality of the evidence
The quality of the evidence, as summarised in Summary of findings for the main comparison for the main comparison, was rated as very low.
Given the considerable number of antibiotics prescribed by dentists to adults with acute dental conditions and the problems associated with indiscriminate use of antibiotics, the paucity of high-quality trials evaluating the effects of systemic antibiotics in the management of symptomatic apical periodontitis and acute apical abscess is disappointing. Only two studies met the inclusion criteria for this review; we judged one to be at high risk of bias and the other to be of unclear risk of bias. Both had methodological ﬂaws with respect to attrition bias and the overall quality of evidence was very low. Furthermore, small group sizes mean that both studies were likely to lack the statistical power to detect differences between intervention and placebo groups. Sample size calculations were not reported in either study. Therefore, caution should be exercised when interpreting the results presented in this review.
Potential biases in the review process
Two independent review authors extracted data and assessed the methodological quality of each study, minimising potential bias.
We are confident that the extensive literature search used in this review has captured relevant literature and minimised the likelihood that we missed any relevant trials.
In the event of incomplete or unclear reporting of trial data, we contacted the trial authors to obtain any unpublished data or clarification of results. We applied no language or publication restrictions in our search.
Despite these efforts, it must be acknowledged that there is a small possibility that there were additional studies (published and unpublished) that we did not identify. It is possible that additional literature searches, such as searching non-English language databases and handsearching relevant journals, would have found additional studies.
Agreements and disagreements with other studies or reviews
Systematic reviews of the emergency management of acute apical periodontitis and acute apical abscess in the permanent dentition were published in 2003 (Matthews 2003; Sutherland 2003). These reviews had wider inclusion criteria and included trials of analgesics, local pharmacotherapeutics and surgical interventions in addition to antibiotic trials. Sutherland 2003 concluded that "the use of antibiotics in the management of AAP [acute apical periodontitis] is not recommended" and Matthews 2003 recommended that "the use of antibiotics in the management of localized AAA [acute apical abscess] over and above establishing drainage of the abscess, is not recommended".
The authors acknowledge the following help in the conduct of the review.
Contact authors of the two included studies.
Anne Littlewood, Trials Search Co-ordinator and Feedback Editor of the Cochrane Oral Health Group, who provided invaluable support in constructing and running the search strategies.
Dr Rebecca Payle, Senior Lecturer in Medical Statistics at Cardiff University School of Dentistry, who gave advice on the statistical elements of the protocol.
Anwen Cope would like to acknowledge the financial support for her PhD research, received from a President's Research Scholarship from Cardiff University.
The assistance of several colleagues who helped with translating articles during the selection of studies.
Declarations of interest
Anwen Cope, Nick Francis, Fiona Wood, Mala Mann, Ivor Chestnutt: no interests to declare.