A prospective study of the factors affecting outcomes of nonsurgical root canal treatment: part 1: periapical health. Root canal treatment in a population-based adult sample: status of teeth after endodontic treatment. Postoperative Pain after Root Canal Treatment: A Prospective Cohort Study Effect of vitamin D supplementation on inflammation: protocol for a systematic review A prospective study of the factors affecting outcomes of non-surgical root canal treatment: part 2: tooth survival. What are the most effective behaviour change techniques to promote physical activity and/or reduce sedentary behaviour in inactive adults? A systematic review protocol Informed Consent: The Rate-Limiting Step in Acute Stroke Trials Mothers’ perceptions of their child’s enrollment in a randomized clinical trial: Poor understanding, vulnerability and contradictory feelings Infrared lasers for the treatment of moderate to severe periodontitis: An American Academy of Periodontology best evidence review Burden and well-being among caregivers: examining the distinction. Circular instead of hierarchical: methodological principles for the evaluation of complex interventions Appreciation of the informed consent procedure in a randomised trial of decompressive surgery for space occupying hemispheric infarction Individuals with low back pain: how do they view physical activity? Improving the recruitment activity of clinicians in randomised controlled trials: a systematic review Surgical offloading procedures for diabetic foot ulcers compared to best non-surgical treatment: a study protocol for a randomized controlled trial Postoperative discomfort associated with surgical and nonsurgical endodontic retreatment. The effect of a bioresorbable matrix barrier in endodontic surgery on the rate of periapical healing: an in vivo study. Abstracts Applicability and Clinical Relevance of Results in Randomized Controlled Trials: The Cochrane Review on Exercise Therapy for Low Back Pain as an Example “Maybe I Made Up the Whole Thing”: Placebos and Patients’ Experiences in a Randomized Controlled Trial Clinical management of nonhealing periradicular pathosis. Surgery versus endodontic retreatment. Incidence of Postoperative Pain after Single Visit and Two Visit Root Canal Therapy: A Randomized Controlled Trial. Assessment of the quality of harms reporting in non-randomised studies and randomised controlled studies of topiramate for the treatment of epilepsy using CONSORT criteria
AIM To investigate the probability of and factors influencing periapical status of teeth following primary ( 1 ° RCT x ) or secondary ( 2 ° RCT x ) root canal treatment .  METHODOLOGY This prospect i ve study involved annual clinical and radiographic follow-up of  1 ° RCT x ( 1170 roots , 702 teeth and 534 patients ) or 2 ° RCT x ( 1314 roots , 750 teeth and 559 patients ) carried out by Endodontic postgraduate students for 2 - 4 ( 50 % ) years . Pre- , intra- and postoperative data were collected prospect ively on customized forms . The proportion of roots with complete periapical healing was estimated , and prognostic factors were investigated using multiple logistic regression models . Clustering effects within patients were adjusted in all models using robust st and ard error . RESULTS proportion of roots with complete periapical healing after 1 ° RCT x ( 83 % ; 95 % CI : 81 % , 85 % ) or 2 ° RCT x ( 80 % ; 95 % CI : 78 % , 82 % ) were similar . Eleven prognostic factors were identified . The conditions that were found to improve periapical healing significantly were : the preoperative absence of a periapical lesion ( P = 0.003 ) ; in presence of a periapical lesion , the smaller its size ( P ≤ 0.001 ) , the better the treatment prognosis ; the absence of a preoperative sinus tract ( P = 0.001 ) ; achievement of patency at the canal terminus ( P = 0.001 ) ; extension of canal cleaning as close as possible to its apical terminus ( P = 0.001 ) ; the use of ethylene-diamine-tetra-acetic acid ( EDTA ) solution as a penultimate wash followed by final rinse with NaOCl solution in 2 ° RCT x cases ( P = 0.002 ) ; abstaining from using 2 % chlorexidine as an adjunct irrigant to NaOCl solution ( P = 0.01 ) ; absence of tooth/root perforation ( P = 0.06 ) ; absence of interappointment flare-up ( pain or swelling ) ( P = 0.002 ) ; absence of root-filling extrusion ( P ≤ 0.001 ) ; and presence of a satisfactory coronal restoration ( P ≤ 0.001 ) . CONCLUSIONS Success based on periapical health associated with roots following 1 ° RCT x ( 83 % ) or 2 ° RCT x ( 80 % ) was similar , with 10 factors having a common effect on both , whilst the 11th factor ' EDTA as an additional irrigant ' had different effects on the two treatments The purpose of this study was to quantify treatment outcomes of  endodontically treated teeth , in a representative , population -based adult sample . The " Florida Dental Care Study " was a prospect i ve , longitudinal , cohort study of 873 subjects who had at least one tooth at baseline and who were 45 yr or older . An in-person interview and clinical examination were conducted at baseline , 24 months , and 48 months after baseline , with 6-monthly telephone interviews between those times . Dental record information was abstract ed afterward . Seventy-five teeth had conventional root-canal therapy ( RCT ) performed and met the inclusion criteria of 1-yr of follow-up or extraction . The mean duration of follow-up after RCT was 24.8 months . The mean ( SD ) attachment loss ( AL ) on teeth receiving RCT was only 3.3 ( 1.4 ) mm . Permanent restorations were placed in 79 % of teeth a mean of 4.4 months after the RCT . However , 12 % of teeth did not have any restorative treatment after RCT . After RCT had been completed , 81 % of teeth were retained and 19 % were ultimately extracted . Taken as a whole , this community-based study of a representative sample of adults suggests a higher failure rate than reported from studies in highly controlled environments or insured population s. It also suggests that the length of time to initial restoration of RCT -treated teeth is less than optimal . RCT was almost never performed on teeth with advanced periodontal attachment loss Aim . To evaluate the incidence and severity of  postendodontic treatment pain ( PEP ) subsequent to root canal treatment ( RCT )  in vital and necrotic pulps and after retreatment . Methodology . A prospect i ve study . Participants were all patients ( n = 274 ) who underwent RCT in teeth with vital pulp , necrotic pulp , or vital pulp that had been treated for symptomatic irreversible pulpitis or who received root canal retreatment , by one clinician , during an eight-month period . Exclusion criteria were swelling , purulence , and antibiotic use during initial treatment . A structured question naire accessed age , gender , tooth location , and pulpal diagnosis . Within 24 h of treatment , patients were asked to grade their pain at 6 and 18 hours posttreatment , using a 1–5 point scale . Results . RCT of teeth with vital pulp induced a significantly higher incidence and severity of PEP ( 63.8 % ; 2.46 ± 1.4 , resp . ) than RCT of teeth with necrotic pulp ( 38.5 % ; 1.78 ± 1.2 , resp . ) or of retreated teeth ( 48.8 % ; 1.89 ± 1.1 , resp . ) . No statistical relation was found between type of pain ( spontaneous or stimulated ) and pulp condition . Conclusion . RCT of teeth with vital pulp induced a significantly higher incidence and intensity of PEP compared to teeth with necrotic pulp or retreated teeth Introduction The extraskeletal role of vitamin D is being increasingly recognised . This has important clinical implication s , as vitamin D deficiency has reached epidemic proportions worldwide . Vitamin D has proposed anti-inflammatory properties , yet the role of vitamin D supplementation in reducing inflammation remains largely unknown . The purpose of this review is to investigate the impact of vitamin D supplementation on inflammation , and to identify relevant knowledge gaps in the field . Methods and analysis Medline , CINAHL , EMBASE and All EBM will be systematic ally search ed for r and omised controlled trials ( RCTs ) and systematic review s of RCTs , comparing vitamin D supplementation with placebo , usual care or other pharmacological or non-pharmacological interventions . One review er will assess articles for eligibility according to prespecified selection criteria , after which 2 independent review ers will perform data extraction and quality appraisal . Meta-analyses will be conducted where appropriate . Ethics and dissemination Formal ethical approval is not required as no primary data is collected . This systematic review will identify potential clinical implication s of vitamin D deficiency and supplementation , and will be disseminated through a peer- review ed publication and at conference meetings , to inform future research on the efficacy of vitamin D supplementation for inflammation and inflammatory diseases . PROSPERO registration number CRD42016037104 AIM To investigate the probability of and factors influencing tooth survival  following primary ( 1 ° RCT x ) or secondary ( 2 ° RCT x ) root canal treatment .  METHODOLOGY This prospect i ve study involved annual follow-up of 2 ( 100 % ) to 4 years ( 50 % ) of 1 ° RCT x ( 759 teeth , 572 patients ) and 2 ° RCT x ( 858 teeth , 642 patients ) carried out by Endodontic postgraduate students . Pre- , intra- and post-operative data were collected prospect ively from consented patients . Information about extraction of the root filled tooth was sought from the patient , the referring dentist or derived from the patient 's records and included the timing and reasons for extraction . Tooth survival was estimated and prognostic factors were investigated using Cox regression . Clustering effects within patients were adjusted in all models using robust st and ard error . RESULTS The 4-year cumulative tooth survival following 1 ° RCT x [ 95.4 % ( 93.6 % , 96.8 % ) ] or 2 ° RCT x [ 95.3 % ( 93.6 % , 96.5 % ) ] was similar . Thirteen prognostic factors were identified . Significant patient factors included history of diabetes and systemic steroid therapy . Significant pre-operative factors included narrow but deep periodontal probing depth ; pain ; discharging sinus ; and iatrogenic perforation ( for 2 ° RCT x cases only ) . Significant intra-operative factors included iatrogenic perforation ; patency at apical terminus ; and extrusion of root fillings . Significant post-operative restorative factors included  presence of cast restoration versus temporary restoration ; presence of cast post and core ; proximal contacts with both mesial and distal adjacent teeth ; and terminal location of the tooth . The presence of pre-operative pain had a profound effect on tooth loss within the first 22 months after treatment [ hazard ratio ( HR ) = 3.1 ; P = 0.001 ] with a lesser effect beyond 22 months ( HR = 2.4 ; P = 0.01 ) . Patency at the apical terminus reduced tooth loss ( HR = 0.3 ; P < 0.01 ) within the first 22 months after treatment but had no significant effect on tooth survival beyond 22 months . Extrusion of gutta-percha root filling did not have any effect on tooth survival ( HR = 1.1 ; P = 0.2 ) within the first 22 months but significantly increased the hazard of tooth loss beyond 22 months ( HR = 3.0 ; P = 0.003 ) . CONCLUSIONS The 4-year tooth survival following primary or secondary root canal treatment was 95 % , with thirteen prognostic factors common to both Introduction Large proportions of the population are not meeting recommended levels of physical activity and have increasingly sedentary lifestyles . Low levels of physical activity are predictive of poor health outcomes and time spent sedentary is related to a host of risk factors independently of physical activity levels . Building an evidence base of the best approaches to intervene in the lifestyles of inactive individuals is crucial in preventing long-term disease , disability and higher mortality rates . Methods and analysis Systematic search es will be conducted on all relevant data bases ( eg , PubMed , Scopus , CINAHL , PsycINFO ) . Studies will be included if they assess interventions aim ed at changing physical activity or sedentary behaviour levels in adults ( over 18 ) who are inactive and do not suffer from chronic conditions . Studies must also be r and omised controlled trials ( RCTs ) , have a primary outcome of physical activity or sedentary behaviour , and measure outcomes at least 6 months after intervention completion . Studies will be coded using the Behaviour Change Technique ( BCT ) taxonomy v1 and Template for Intervention Description and Replication ( TIDieR ) guidelines . 2 review ers will independently screen full-text articles and extract data on study characteristics , participants , BCTs , intervention features and outcome measures . Study quality will also be assessed independently by 2 review ers using the Cochrane risk of bias tool . A meta- analysis will be considered if there is sufficient homogeneity across outcomes . GRADE criteria will be used to assess quality of evidence . Dissemination This will be the first review to systematic ally appraise interventions aim ed at changing the physical activity or sedentary behaviour of inactive individuals using RCT design s with a 6-month follow-up post-intervention . This review will better inform intervention design ers targeting inactive population s and inform the design of a future complex intervention . Review registration number This protocol was registered with the International Prospect i ve Register of Systematic Review s ( PROSPERO ) on 17 October 2014 ( registration number : CRD42014014321 ) Successful implementation of a r and omized clinical trial ( RCT ) for neuro-vascular emergencies such as cerebral infa rct ion , intracerebral hemorrhage , or subarachnoid hemorrhage is extraordinarily challenging . Besides establishing an accurate , hyper-expedited diagnosis among many mimics in a person with acute neurological deficits , informed consent must be obtained from this vulnerable group of patients who may be unable to convey their own wishes , grasp the gravity of their situation , or give a complete history or examination . We review the influences , barriers , and factors investigators encounter when providing established and putative stroke therapies , and focus on informed consent , the most important research protector of human subjects , as the rate-limiting step for enrollment into acute stroke RCTs . The informed consent process has received relatively little attention in the stroke literature , but is especially important for stroke victims with acute cognitive , aural , lingual , motor , or visual impairments .  Consent by a surrogate may not accurately reflect the patient ’s wishes . Further , confusion about trial methodology , negative opinions of placebo-controlled studies , and therapeutic misconception by patients or surrogates may impede trial enrollment and requires further study . Exception from informed consent offers an opportunity that is rarely if ever utilized for stroke RCTs . Ultimately , advancing the knowledge base and treatment paradigms for acute stroke is essential but autonomy , beneficence ( non-malfeasance ) , and justice must also be carefully interwoven into any well- design ed RCT Background Little is known about the views of mothers when their children are invited to participate in r and omized clinical trials ( RCTs ) investigating medicines and /or invasive procedures . Our goal was to underst and mothers ’ perceptions of the processes of informed consent and r and omization in a RCT that divided uncooperative children into three intervention groups ( physical restraint , sedation , and general anesthesia ) for dental rehabilitation . Methods This is a qualitative study based on semi-structured interviews with mothers accompanying children under 3 years old presenting severe early childhood caries . Their responses were analyzed using content analysis . Results We identified one major theme from 15 mothers ’ responses – “ Underst and ing of , attitudes toward , and feelings about consenting to participate in a RCT involving advanced behavior guidance techniques and about r and omization ” – that was derived from the following subcategories : confusion in defining techniques , questions after signing the consent form , lack of knowledge about the techniques , acceptance or question ing of the drawing , sharing responsibility with the child during the drawing , and feelings of faith in God , fear , powerlessness to choose , and relief from or an increase in pressure . Conclusions Despite mothers ’ misunderst and ing , vulnerability , and contradictory feelings , they were willing to overlook their thoughts in order to complete their children ’s dental treatment BACKGROUND This systematic review assesses the efficacy of infrared laser therapy used alone or as an adjunct to nonsurgical or surgical periodontal therapy , on clinical and patient-centered outcomes in patients with periodontitis . METHODS R and omized clinical trials ( RCTs ) with a follow-up duration ≥3 months that evaluated root surface debridement ( i.e. , scaling and root debridement with or without surgical access ) to laser therapy alone or laser therapy plus root surface debridement for the treatment of adult patients ( ≥18 years old ) with moderate to severe aggressive or chronic periodontitis were considered eligible for inclusion . The MEDLINE , EMBASE and CENTRAL data bases were search ed for articles published up to and including March 2016 . R and om effects meta-analyses were used throughout the review using continuous data ( i.e. , mean changes from baseline ) , and pooled estimates were expressed as weighted mean differences ( MDs ) with their associated 95 % confidence intervals ( CIs ) . Additionally , summaries are presented of the included RCTs , critical remarks of the literature and evidence quality rating/strength of recommendation of laser procedures . RESULTS Of the 475 potentially eligible articles , 28 were included in the review . Individual study outcomes and seven sets of meta- analysis ( 1 for the nonsurgical treatment of AgP and 9 for nonsurgical and surgical treatment of CP ) showed a benefit of laser therapy in improving clinical attachment level ( CAL ) and probing depth ( PD ) . However , the comparative differences in clinical outcomes were modest ( < 1 mm ) and the level of certainty for different therapies was considered low-to-moderate ( i.e. , more information would be necessary to allow for a reliable and definitive estimation of effect/magnitude of therapies on health outcomes ) . Overall , most of the Strength of Clinical Recommendations of laser therapies were considered weak or based on expert opinion . CONCLUSIONS In patients with moderate to severe periodontitis , the nonsurgical treatment of AgP and CP by SRP plus infrared diode laser , and the surgical treatment of CP by Er : YAG laser therapy alone may promote statistically significant improvements in PD and CAL . However , these gains are relatively small ( < 1 mm ) and provide modest clinical relevance compared with SRP alone PURPOSE This study assessed overall quality of life of caregivers , using a path model in which burden was conceptualized as distinct from well-being . DESIGN AND METHODS Data were drawn from a representative sample of caregivers to dementia and nondementia care receivers in British Columbia , Canada ( N = 243 ) . The model used was based on a previously proposed stress/ appraisal path model and used multiple regression path estimates . Primary stressors were care receiver cognitive status , physical function , and behavioral problems ; the primary appraisal variable was hours of caregiving during the previous week . Mediators were perceived social support , frequency of getting a break , and hours of formal service use ; secondary appraisal was subjective burden . The outcome measure was generalized well-being . RESULTS Well-being was directly affected by four variables : perceived social support , burden , self-esteem , and hours of informal care . Burden was affected directly by behavioral problems , frequency of getting a break , self-esteem , and informal hours of care and was not affected by perceived social support . DISCUSSION The finding that perceived social support is strongly related to well-being but unrelated to burden reinforces the conceptual distinctiveness of the latter two concepts . This suggests that quality of life of caregivers could be improved even with burden in their lives and that the overwhelming focus in caregiving research on burden should be supplemented with an emphasis on quality of life Background The reasoning behind evaluating medical interventions is that a hierarchy of methods exists which successively produce improved and therefore more rigorous evidence based medicine upon which to make clinical decisions . At the foundation of this hierarchy are case studies , retrospective and prospect i ve case series , followed by cohort studies with historical and concomitant non-r and omized controls . Open-label r and omized controlled studies ( RCTs ) , and finally blinded , placebo-controlled RCTs , which offer most internal validity are considered the most reliable evidence . Rigorous RCTs remove bias . Evidence from RCTs forms the basis of meta-analyses and systematic review s. This hierarchy , founded on a pharmacological model of therapy , is generalized to other interventions which may be complex and non-pharmacological ( healing , acupuncture and surgery ) . Discussion The hierarchical model is valid for limited questions of efficacy , for instance for regulatory purpose s and newly devised products and pharmacological preparations . It is inadequate for the evaluation of complex interventions such as physiotherapy , surgery and complementary and alternative medicine ( CAM ) . This has to do with the essential tension between internal validity ( rigor and the removal of bias ) and external validity ( generalizability ) . Summary Instead of an Evidence Hierarchy , we propose a Circular Model . This would imply a multiplicity of methods , using different design s , counterbalancing their individual strengths and weaknesses to arrive at pragmatic but equally rigorous evidence which would provide significant assistance in clinical and health systems innovation . Such evidence would better inform national health care technology assessment agencies and promote evidence based health reform Background and aim : As non-r and omised studies have suggested that surgical decompression may reduce mortality in patients with space occupying hemispheric infa rct ion , r and omisation may be considered unethical in controlled trials testing this treatment strategy . We studied differences in recall of information and in appreciation of the informed consent procedure between representatives included in the Hemicraniectomy After Middle cerebral artery infa rct ion with Life-threatening Edema Trial ( HAMLET ) and representatives of patients participating in the r and omised trial of Paracetamol ( Acetaminophen ) In Stroke ( PAIS ) . Methods : 1 year after study inclusion , we contacted 30 consecutive representatives who had given informed consent for participation of their relative in HAMLET , and 30 for PAIS .  Recall of trial details and appreciation of the informed consent procedure were investigated using st and ardised question naires and compared between the two groups . Results : All 30 PAIS representatives and 28 HAMLET representatives were interviewed . Participation of their relative in a clinical trial was remembered by 86 % of HAMLET and 40 % of PAIS representatives ( p<0.001 ) . HAMLET representatives remembered more trial details ( effect of the treatment under study ( 61 % vs 3 % , p<0.001 ) ; r and omised treatment allocation ( 71 % vs 0 % , p<0.001 ) ) . With respect to appreciation of the informed consent procedure , we found no differences between the groups : in each trial , four representatives ( 14 % vs 13 % ) had considered the question of r and omisation unacceptable . Conclusions : Participation of patients in a r and omised controlled trial of surgical decompression for space occupying infa rct ion is generally considered acceptable by their representatives , and recall of trial details is better than in a trial in which less vital issues are at stake BACKGROUND Recent guidelines for those with acute low back pain have advocated early resumption of normal activity and increased physical activity . Little is known about the relationship between low back pain and physical activity , and on the impact of that relationship on the promotion of increased levels of physical activity within a general practice population . OBJECTIVES We aim ed to explore associations between factors that influence changes in physical activity and the way individuals perceive and behave with their low back pain , and the impact of those perceptions and behaviour on physical activity . METHODS Twenty-seven informants were chosen using a purposive sample from a larger group of individuals who , because of their low back trouble , had been referred by their GPs to a community-based , single-blind , r and omized controlled trial ( RCT ) at the University of York , which is evaluating the effectiveness and cost-effectiveness of a progressive exercise programme . Fifty-four interviews were conducted with this subgroup of the RCT ; four informants were interviewed once , 19 twice and four of them three times . Interviews were transcribed and analysed using manual and computer-aided approaches . RESULTS Physical activity was perceived as ( i ) activities of daily living , ( ii ) activities causing breathlessness that they went out of the way to do and ( iii ) more competitive-type activity . The avoidance of physical activity and fear of pain returning were the two main factors directly associated with informants ' backs and changes in physical activity . These two factors hindered increases in physical activity , even though the majority of informants believed strongly that being physically active helped ease their low back pain . CONCLUSIONS When advocating that individuals with acute low back pain return to or increase physical activity , it is important that clinicians identify avoidance of physical activity and /or fear of pain at the earliest stage in order to tailor advice and reassurance appropriately . If avoidance of activity and fear of pain is identified and clinicians want to encourage patients to take up and sustain increased physical activity , they should explore issues of fear of pain , and avoidance of and confidence to do physical activities , in addition to other factors influencing physical activity Background Poor recruitment to r and omised controlled trials ( RCTs ) is a widespread problem . Provision of interventions aim ed at supporting or incentivising clinicians may improve recruitment to RCTs . Objectives To quantify the effects of strategies aim ed at improving the recruitment activity of clinicians in RCTs , complemented with a synthesis of qualitative evidence related to clinicians ' attitudes towards recruiting to RCTs . Data sources A systematic review of English and non-English articles identified from : The Cochrane Library , Ovid MEDLINE , Ovid EMBASE , Ovid PsycINFO , Ebsco CINAHL , Index to Theses and Open SIGLE from 2001 to March 2011 . Additional reports were identified through citation search es of included articles . Study eligibility criteria Quantitative studies were included if they evaluated interventions aim ed at improving the recruitment activity of clinicians or compared recruitment by different groups of clinicians . Information about host trial , study design , participants , interventions , outcomes and host RCT was extracted by one research er and checked by another . Studies that met the inclusion criteria were assessed for quality using a st and ardised tool , the Effective Public Health Practice Project tool . Qualitative studies were included if they investigated clinicians ' attitudes to recruiting patients to RCTs . All results / findings were extracted , and content analysis was carried out . Overarching themes were abstract ed , followed by a meta summary analysis . Studies that met the inclusion criteria were assessed for quality using the Critical Appraisal Skills Programme qualitative checklist . Data extraction Data extraction was carried out by one research er using predefined data fields , including study quality indicators , and verified by another . Results Eight quantitative studies were included describing four interventions and a comparison of recruiting clinicians . One study was rated as strong , one as moderate and the remaining six as weak when assessed for quality using the Effective Public Health Practice Project tool . Effective interventions included the use of qualitative research to identify and overcome barriers to recruitment , reduction of the clinical workload associated with participation in RCTs and the provision of extra training and protected research time . Eleven qualitative studies were identified , and eight themes were abstract ed from the data : underst and ing of research , communication , perceived patient barriers , patient – clinician relationship , effect on patients , effect on clinical practice , individual benefits for clinicians and methods associated with successful recruitment . Meta summary analysis identified the most frequently reported subthemes to be : difficulty communicating trial methods , poor underst and ing of research and priority given to patient well-being . Overall , the qualitative studies were found to be of good quality when assessed using the Critical Appraisal Skills Programme checklist . Conclusions There were few high- quality trials that tested interventions to improve  clinicians ' recruitment activity in RCTs . The most promising intervention was the use of qualitative methods to identify and overcome barriers to  clinician recruitment activity . More good quality studies of interventions are needed to add to the evidence base . The meta summary of qualitative findings identified underst and ing and communicating RCT methods as a key target for future interventions to improve recruitment . Reinforcement of the potential benefits , both for clinicians and for their patients , could also be a successful factor in improving recruitment . A bias was found towards investigating barriers to recruitment , so future work should also encompass a focus on successfully recruiting trials Background Diabetic foot ulcers are frequently related to elevated pressure under a bony prominence . Conservative treatment includes offloading with orthopaedic shoes and custom made orthotics or plaster casts . While casting in plaster is usually effective in achieving primary closure of foot ulcers , recurrence rates are high . Minimally invasive surgical offloading that includes correction of foot deformities has good short and long term results . The surgery alleviates the pressure under the bony prominence , thus enabling prompt ulcer healing , negating the patient ’s dependence on expensive shoes and orthotics , with a lower chance of recurrence . The purpose of this protocol is to compare offloading surgery ( percutaneous flexor tenotomy , mini-invasive floating metatarsal osteotomy or Keller arthroplasty ) to non-surgical treatment for patients with diabetic foot ulcers in a semi-crossover design ed RCT . Methods One hundred patients with diabetic neuropathy related foot ulcers ( tip of toe ulcers , ulcers under metatarsal heads and ulcers under the hallux interphalangeal joint ) will be r and omized ( 2:3 ) to a surgical offloading procedure or best available non-surgical treatment . Group 1 ( surgery ) will have surgery within 1 week . Group 2 ( controls ) will be prescribed an offloading cast applied for up to 12 weeks ( based on clinical considerations ) . Following successful offloading treatment ( ulcer closure with complete epithelization ) patients will be prescribed orthopaedic shoes and custom made orthotics . If offloading by cast for at least 6 weeks fails , or the ulcer recurs , patients will be offered surgical offloading . Follow-up will take place till 2 years following r and omization . Outcome criteria will be time to healing of the primary ulcer ( complete epithelization ) , time to healing of surgical wound , recurrence of ulcer , time to recurrence and complications . Discussion The high recurrence rate of foot ulcers and their dire consequences justify attempts to find better solutions than the non-surgical options available at present . To promote surgery , RCT level evidence of efficacy is necessary . Trial registration Israel MOH_2017–08 - 10_000719 . NIH : NCT03414216 Endodontic retreatment decision-making must include an appraisal of the costs of the different strategies proposed . In addition to direct costs , postoperative discomfort may have other consequences in terms of time off work , unscheduled visits and suffering . To establish a foundation for the appraisal of such indirect and intangible costs the present study was set up in which patients ' assessment s of pain and swelling after surgical and nonsurgical retreatment procedures were recorded . Ninety-two patients with 95 root-filled incisors and canine teeth exhibiting apical periodontitis were included in the study . The mode of retreatment was r and omly assigned . Each day during the first post-treatment week patients assessed their degree of swelling and pain on horizontal 100-mm visual analog scales ( VAS ) . The scales ranged from " no swelling " to " very severe swelling " and " no pain " to " intolerable pain " , respectively . Consumption of self-prescribed analgesics and time off work were also recorded . Significantly more patients reported discomfort after surgical retreatment than after nonsurgical procedures .  High pain scores were most frequent on the operative day while swelling reached its maximum on the first postoperative day followed by progressive decrease both in frequency and magnitude . Postoperative symptoms associated with nonsurgical retreatment were less frequent but reached high VAS values in single cases .  Analgesics  were significantly more often consumed after periapical surgery . Patients reported absence from work mainly due to swelling and discoloration of the skin . This was found to occur only after surgical retreatment . Conclusively , surgical retreatment result ed in more discomfort and tended to bring about greater indirect costs than nonsurgical retreatment The purpose of this prospect i ve clinical study was to assess the rate of healing of periapical bony defects created at the time of endodontic periapical surgery  by measuring the densitometric ratio change in periapical osseous tissues , after periapical endodontic surgery was performed , by using or not using Guidor bioresorbable membrane material . Periapical surgeries were performed on 25 patients where nonsurgical root canal therapy had failed and a periapical lesion was present . For inclusion in the study , the osseous defect to be analyzed had to be confined to the apical area , with bone covering the entire root surface coronally , and an intact lingual cortical plate had to be present . A series of radiographs at the 3- , 6- , and 12-month recalls were compared with the radiograph taken immediately after surgery by using digital imaging and a densitometric ratio that gave a numerical estimation of osseous healing . Using repeated-measure ANOVA , it was shown that there was no statistical difference between the rate of healing in those cases where a Guidor resorbable membrane was used and those cases where no membrane was used . The results suggest that placement of a guided tissue membrane over the bony opening created during an endodontic periapical surgical procedure has no beneficial effect on the rate of healing and the added expense to the patient would not be warranted in these cases Information of " success " rates after  surgical or nonsurgical endodontic retreatment  is abundant but inconclusive . Reported healing frequencies vary between 45 % and 90 % . The present study was design ed to find any systematic difference between the methods . Nonsurgical and surgical retreatment was r and omly assigned to 95 endodontically " failed " cases . The outcome of the procedures was clinical ly and radiographically recorded , and followed for 4 years . At the 12-month recall , a statistically significant ( p < 0.05 ) higher healing rate was observed for cases surgically retreated . At the final 48-month examination , no such difference was found . These findings may be explained by ( a ) slower healing dynamics in the nonsurgical group and ( b ) the event of late " failures " in the surgical group . Within the latter category , four cases classified as healed after 1 yr failed at the final follow-up . Conclusively , this study failed to show any systematic difference in the outcome of surgical and nonsurgical endodontic retreatment . Surgical retreatment seems to result in more rapid periapical bone fill , but also may imply a higher risk of " late failures . " From a scientific point of view , the length of the follow-up period is very important and may strongly influence the conclusions made Study Design . A critical appraisal of the literature . Objectives . To increase awareness of the importance of applicability and clinical relevance of the results of r and omized controlled trials ( RCTs ) in the field of spinal disorders by formulating a list of items for assessment of applicability and clinical relevance of results of RCTs . Summary of Background Data . In systematic review s of r and omized controlled trials ( RCTs ) , critical appraisal of method ologic quality is considered important . Less attention has been paid to the assessment of the applicability and the clinical relevance of the results . Methods . RCTs in an up date of the Cochrane review on  exercise therapy for low back pain were used . Most of the trials did not score positively on the five Cochrane Back Review Group basic items describing patients : intervention and setting , outcome , effect size , and benefits related to adverse effects . Item 1 was met by 88 % of the trials , but item 2 only by 51 % , item 3 by 67 % , item 4 by 35 % , and item 5 by 0 % . Subsequently , a more comprehensive list of items for the assessment of applicability and clinical relevance of results of RCTs was developed . These criteria were pilot tested on the RCTs . After pilot testing and a subsequent consensus meeting , the list of items was drafted and circulated among the members of the Editorial Board of the Cochrane Back Review Group . Changes were made in response to comments . Results . The final list consists of 40 items . The items are ordered on two headings : Does the report enable the assessment of applicability ? Are the study results clinical ly relevant ? We present examples of informative and noninformative reporting of RCTs in order to illustrate how information on applicability and clinical relevance of results can be assessed . Conclusions . Authors of RCTs should adequately report on items that are essential to assess the applicability and clinical relevance of results . The presented list of items may help clinicians reading RCTs and authors of systematic review s to draw more balanced conclusions on applicability and clinical relevance of results Patients in the placebo arms of r and omized controlled trials ( RCT ) often experience positive changes from baseline . While multiple theories concerning such “ placebo effects ” exist , peculiarly , none has been informed by actual interviews of patients undergoing placebo treatment . Here , we report on a qualitative study ( n = 27 ) embedded within a RCT ( n = 262 ) in patients with irritable bowel syndrome . Besides identical placebo acupuncture treatment in the RCT , the qualitative study patients also received an additional set of interviews at the beginning , midpoint , and end of the trial . Interviews of the 12 qualitative subjects who underwent and completed placebo treatment  were transcribed . We found that patients ( 1 ) were persistently concerned with whether they were receiving placebo or genuine treatment ; ( 2 ) almost never endorsed “ expectation ” of improvement but spoke of “ hope ” instead and frequently reported despair ; ( 3 ) almost all reported improvement ranging from dramatic psychosocial changes to unambiguous , progressive symptom improvement to tentative impressions of benefit ; and ( 4 ) often worried whether their improvement was due to normal fluctuations or placebo effects . The placebo treatment was a problematic perturbation that provided an opportunity to reconstruct the experiences of the fluctuations of their illness and how it disrupted their everyday life . Immersion in this RCT was a co-mingling of enactment , embodiment and interpretation involving ritual performance and evocative symbols , shifts in bodily sensations , symptoms , mood , daily life behaviors , and social interactions , all accompanied by self-scrutiny and re- appraisal . The placebo effect involved a spectrum of factors and any single theory of placebo — e.g . expectancy , hope , conditioning , anxiety reduction , report bias , symbolic work , narrative and embodiment — provides an inadequate model to explain its salubrious benefits OBJECTIVES This prospect i ve r and omized study compared the outcome of retreatment and surgical intervention in root canal treated teeth with nonhealing periradicular pathosis . STUDY DESIGN One such tooth from each of 38 patients was r and omly allotted to retreatment or root-end resection and root-end filling . Treatment outcome after 1 year was evaluated and compared clinical ly and radiographically . RESULTS The success rate for surgery was higher than for conventional retreatment , but the difference was not statistically significant . CONCLUSIONS For management of nonhealing periradicular pathosis associated with root canal treated teeth , surgical intervention should be considered as an alternative to retreatment . In cases with a similar prognosis for both modes of treatment , the choice should be governed by consideration of intrinsic and extrinsic factors INTRODUCTION Root Canal Treatment ( RCT ) has become a mainstream procedure in dentistry . A successful RCT is presented by absence of clinical signs and symptoms in teeth without any radiographic evidence of periodontal involvement . Completing this procedure in one visit or multiple visits has long been a topic of discussion . AIM To evaluate the incidence of postoperative pain after root canal therapy performed in single visit and two visits . MATERIAL AND METHODS An unblinded/ open label r and omized controlled trial was carried out in the endodontic department of the Dental Institute , where 78 patients were recruited from the regular pool of patients . A total of 66 maxillary central incisors requiring root canal therapy fulfilled the inclusion and exclusion criteria . Using simple r and omization by biased coin r and omization method , the selected patients were assigned into two groups : group A ( n=33 ) and group B ( n=33 ) . Single visit root canal treatment was performed for group A and two visit root canal treatment for group B. Independent sample t-test was used for statistical analysis . RESULTS Thirty three patients were allotted to group A where endodontic treatment was completed in single visit while 33 patients were allotted to group B where endodontic treatment was completed in two visits . One patient dropped-out from Group A. Hence in Group A , 32 patients were analysed while in Group B , 33 patients were analysed . After 6 hours , 12 hours and 24 hours of obturation , pain was significantly higher in Group B as compared to Group A. However , there was no significant difference in the pain experienced by the patients 48 hours after treatment in both the groups . CONCLUSION Incidence of pain after endodontic treatment being performed in one-visit or two-visits is not significantly different PURPOSE Treatment decisions should be informed by high quality evidence of both the potential benefit and harms of treatment alternatives . R and omised controlled trials ( RCTs ) provide the best evidence regarding benefits ; however information relating to serious , rare and long-term harms is usually available only from non-r and omised studies ( NRSs ) . The aim of this study was to use a checklist based on the CONSORT ( Consolidating St and ards for Reporting Trials ) extension for harms recommendations to assess the quality of reporting of harms data in both NRSs and RCTs of antiepileptic drugs , using studies of topiramate as an example . RESULTS Seventy-eight studies were included from an online search of seven data bases .  Harms data was extracted from each study using a 25-point checklist . The mean number of items met was 11.5 ( SD 2.96 ) per study . Commercially funded studies met on average 12.7 items and non-commercially funded studies met 10.08 ( p value < 0.001 ) . RCTs met on average 13.0 items and NRSs met 10.8 ( p = 0.001 ) . Multi-centre studies and commercially funded studies met significantly more items than single centre and non-commercially funded studies respectively . There was no significant difference in the mean number of items met by studies that had included adult vs. child participants , or studies published pre- vs. post-CONSORT extension for harms in 2004 . CONCLUSIONS Reporting of harms is significantly better in RCTs than in NRSs of TPM , but is suboptimal overall and has not improved since the publication of CONSORT extension for harms in 2004 . There is a need to improve the reporting of harms in order to better inform treatment decisions
RESULTS Application of the Oral Health Impact Profile ( OHIP ) demonstrated that disease of pulpal origin affects quality of life with moderate severity , primarily through physical pain and psychological discomfort , and that RCT results in broad improvement of quality of life .
Satisfaction with RCT is extremely high , but cost is the primary reason for dissatisfaction .
Anxiety and fear affect RCT patients , profoundly influencing their behaviors , including treatment avoidance , and their pain experience .
Fear of pain is " fair " to " very much " prior to RCT .
Pain is widely feared , disliked , and remembered ; however , disease of pulpal origin generally produces moderate , but not severe pain .
RCT causes a dramatic decrease in pain prevalence and severity over the week following treatment .
Survival rates of teeth after RCT are very high ; complication rates are low .
Cost is a barrier to RCT , but initial costs , lifetime costs , cost effectiveness , cost utility , and cost benefit all compare extremely well to the alternatives involving replacement using implants or fixed prostheses .
INTRODUCTION Root canal treatment ( RCT ) success criteria inform us of the path to bony healing and of prognostic factors , but tell little about how the patient perceives , feels , or values RCT .
Patients choose , undergo , and pay for RCT , they live with the result , and inform their community .
The purpose of this narrative review was to appraise patient-centered outcomes of initial non-surgical RCT and nonsurgical retreatment , in adults .