title: A randomised clinical trial to investigate bond failure rates using a self-etching primer. CONSORT statement: extension to cluster randomised trials A comparative assessment of the failure rate of molar tubes bonded with a self-etching primer and conventional acid-etching. Eighteen-month bracket survival rate: conventional versus self-etch adhesive. Failure rate of brackets bonded with antimicrobial and fluoride-releasing, self-etching primer and the effect on prevention of enamel demineralization. A Randomized Clinical Trial Comparing ‘One-Step’ and ‘Two-Step’ Orthodontic Bonding Systems An Investigation into the Use of a Single Component Self-etching Primer Adhesive System for Orthodontic Bonding: A Randomized Controlled Clinical Trial Six and 12 months' evaluation of a self-etching primer versus two-stage etch and prime for orthodontic bonding: a randomized clinical trial. Bias in Systematic Reviews? Long-Term Clinical Evaluation of Bracket Failure with a Self-Etching Primer: A Randomized Controlled Trial Importance of pumice prophylaxis for bonding with self-etch primer. Bond failure rates with a self-etching primer: a randomized controlled trial.
abstract: This clinical trial evaluated , over a 12-month period , the performance of brackets bonded to teeth etched and primed with Transbond Plus Self-Etching Primer ( SEP ) when compared with a conventional separate two-step etch and primer system .  Thirty-nine r and omly selected patients requiring fixed appliance therapy were entered into the study . R and om allocation of each etching system , along with a ' split-mouth cross-quadrant ' design was used . A total of 661 brackets were placed by two operators . The failure and survival rates of the brackets were determined for age and gender of the patients , each etching system , operator , mode of failure , tooth position in the dental arch , and number of manipulations prior to curing the adhesive . Statistical analysis showed that SEP had a significantly higher bond failure rate ( 11.2 per cent ) than the conventional etch and primer system ( 3.9 per cent ) at the P = 0.001 level . Cox 's proportional hazards regression showed the conventional etch and primer system to have a 60 per cent reduced chance of bracket failure over a 12-month observation period , while males had a 2.4 times increased risk compared with females . The predominant mode of failure was at the composite enamel interface for the SEP , while for the conventional etch and primer system , it was within the composite adhesive . No statistically significant differences were found for the failure rate with respect to the age of the patient , operator , tooth location , or the number of manipulations of the bracket . This in vivo study showed that brackets bonded using SEP had an increased clinical bond failure rate compared with the conventional , separate , etch and prime system Reports of cluster r and omised trials require additional information to allow readers to interpret them accurately The effective reporting of r and omised controlled trials has received useful attention in recent years . Many journals now require that reports conform to the guidelines in the Consoli date d St and ards of Reporting Trials ( CONSORT ) statement , first published in 1996 and revised in 2001 . The statement includes a checklist of items that should be included in the trial report . These items are evidence based whenever possible and are regularly review ed . The statement also recommends including a flow diagram to show the flow of participants from group assignment through to the final analysis . The CONSORT statement focused on reporting parallel group r and omised trials in which individual participants are r and omly assigned to study groups . However , in some situations it is preferable to r and omly assign groups of individuals ( such as families or medical practice s ) rather than individuals . Reasons include the threat of contamination of some interventions ( such as dietary interventions ) if individual r and omisation is used . 5 Also , in certain setting s r and omisation by group may be the only feasible method of conducting a trial . Trials with this design are variously known as field trials , community based trials , place based trials , or ( as in this paper ) cluster r and omised trials . In an earlier discussion paper we considered the implication s of the CONSORT statement for the reporting of cluster r and omised trials . Here we present up date d guidance , based on the 2001 revision of the CONSORT statement OBJECTIVES Comparative assessment of the failure rate of molar tubes bonded to first and second molars with a self-etching primer and conventional acid-etching . MATERIAL AND METHODS Four hundred forty-four molar tubes ( 246 first molar tubes and 198 second molar tubes ) were bonded , using a split-mouth design , on 62 patients ( 23 male , 39 female ; mean age 13.7 years ) with the 3 M Transbond Plus self-etching primer combined with Transbond XT paste ; or with conventional acid-etching , Orthosolo primer , and Enlight adhesive paste .  First-time failures were recorded over a period of 15 months . RESULTS Bond failure per adhesive system , arch ( maxilla-m and ible ) , quadrant ( left , right ) and tooth ( first or second molar ) were studied . Statistical analysis using logistic regression modeling ( alpha = .05 ) showed that the overall failure rate for the first and second molar tubes was 11 % ( 8 % with self-etching primer and 13 % with conventional acid-etching ) . No significant difference was found between the 2 bonding methods . Tooth location and type showed statistically significant associations . M and ibular tubes showed a 3:1 probability for failure compared to maxillary tubes . Right-sided tubes demonstrated 3 times more failures when compared to left-sided tubes , and second molar tubes showed a 3-fold increase in failure . CONCLUSION Molar tube bonding with self-etching primer shows similar success rates to conventional acid-etching , whereas the m and ibular right second molar presents the highest failure incidence The aim of this study was to evaluate , over an 18-month period , the clinical performance of a self-etch adhesive [ Transbond Plus Self Etching Primer ( SEP ) , 3 M Unitek ] compared with a conventional adhesive that employs the etch- and -rinse approach ( Transbond XT , 3 M Unitek ) . One operator , using the straight-wire technique , bonded 567 metallic brackets to the teeth of 30 patients ( age range 12 - 18 years ) in a way that patients acted as self-control . The brackets were bonded following the manufacturers ' instructions except for the fact that the self-etch system was brushed for a longer time than recommended ( 10 - 15 seconds ) since previous investigations have reported that prolonged application times can improve the bonding efficacy of self-etch systems to enamel . The failure modes were visually classified into : adhesive-enamel , adhesive-bracket , and cohesive failure . The survival rates of the brackets were estimated by Kaplan-Meier and log-rank test ( P < 0.05 ) . The failure rates of the self-etch and conventional adhesives were 15.6 and 17.6 per cent , respectively . No significant differences in the survival rate were observed between the material s ( P > 0.05 ) . Most of the failures were cohesive and at the adhesive-enamel interface . There was no difference in the fracture debonding mode . These findings indicate that Transbond Plus SEP can be safely used for orthodontic brackets since the survival rates are similar to the conventional Transbond XT INTRODUCTION Our aim in this r and omized clinical trial was to compare the failure rates of orthodontic brackets by using 2 self-etching primers ( SEPs ) ( Transbond Plus [ 3 M Unitek , Seefeld , Germany ] and Clearfil Protect Bond [ Kuraray Medical , Okayama , Japan ] ) with a split-mouth design . Additionally , the effect of Clearfil Protect Bond was investigated regarding inhibition of plaque accumulation and demineralization . METHODS A total of 480 brackets were bonded in 24 patients with the SEPs .  The observation period was 12 months . One week after bonding and at every third recall , the plaque index and a visual rating of the enamel adjacent to the bracket were assessed at the lateral incisors and the first premolars . Additionally ,  DIAGNOdent  ( KaVo , Biberach , Germany ) values were measured . RESULTS Over the investigation time , 26 failures were recorded . Five occurred with the brackets bonded with Transbond Plus , and the rest with Clearfil Protect Bond ( P = 0.002 ) . The additionally observed parameters had no significant differences . CONCLUSIONS The failure rate with Clearfil Protect Bond was significantly higher . For our patients , who had adequate oral hygiene , there was no benefit with regard to plaque accumulation and prevention of demineralization with Clearfil Protect Bond Objective The primary objective of this prospect i ve clinical trial was to assess the clinical bond failure rates of orthodontic brackets bonded using a self-etching primer ( SEP ) , compared with brackets bonded using a conventional acid-etched technique with control adhesive ( Transbond ™ ) . A secondary aim was to investigate whether characteristics of the operator , patient or tooth bonded had any influence on bracket failure . Design Single-centre r and omized controlled clinical trial . Thirty-four patients were bonded , each being r and omly assigned to either the test or control adhesive . Setting NHS Hospital Orthodontic Department , Chester , UK . Subjects Orthodontic patients requiring fixed appliance treatment . Main outcome measures Bond failure . Main outcome results Failure rates over the initial 6-month period were 2.0 % ( Transbond ™ ) and 1.7 % ( SEP ) with no statistically significant difference between the two groups . Over the duration of the fixed appliance treatment , bond failure rates increased , but remained acceptable at 7.4 % ( TB ) and 7.0 % ( SEP ) , respectively . When operator , patient and tooth characteristics were analysed , only the bracket location was found to be significant . Maxillary brackets were more likely to fail than m and ibular brackets ( RR 0.47 % ; 95 % CI 0.22 , 1.03 ) . The failure rate for brackets in our study was low when compared with previous studies . Conclusions Both the acid-etched control and self-etching primer in combination with adhesive pre-coated brackets were successful for clinical bonding . Their combined failure rate was lower than that reported in similar trials Objective This study assessed the in vivo bond failure of the single component orthodontic self-etching primer system , Ideal 1 ( GAC Orthodontic Products ) and compared it with the conventional acid etching using a conventional 37 % o-phosphoric acid , rinsing and drying regimen when bonding stainless steel orthodontic brackets to enamel . Design Prospect i ve r and omized , controlled clinical trial . Setting Orthodontic Department , Bristol Dental School . Material and methods Twenty consecutive patients undergoing upper and lower fixed orthodontic treatment entered this cross-mouth control study . Diagonally opposite quadrants were r and omly allocated to either the self-etching primer group or the conventional etching group . A total of 339 teeth were bonded with Ideal 1 light-cured adhesive . Bond failures and locus of bond failure were then recorded at 1 , 6 and 12 months . Results Significantly more bond failures occurred at each of the 3 time intervals , 1 , 6 and 12 months , where the enamel was pretreated with the Ideal I self-etching primer , than when the enamel was treated with the conventional etchant , 37 % o-phosphoric acid . With the latter the cumulative bond failure rates were 3.0 , 5.3 and 14.8 % , respectively . With the self-etching primer the cumulative failure rates were 29.4 , 56.5 and 72.4 % . Conclusion The study found that enamel pre-treatment with the Ideal 1 self-etching primer system prior to orthodontic bonding results in an unacceptably high bond failure rate when compared with conventional enamel acid etching The aim of the study was to compare the mean clinical chair-side time required for bracket bonding and the mean bond failure rate at 6 and 12 months of stainless steel brackets with a micro-etched base bonded with a light-cured composite using a self-etching primer ( SEP ) or a two-stage etch and prime system .  Fifty-one subjects who required upper and /or lower pre-adjusted edgewise fixed appliances were recruited in a single centre r and omized clinical trial . The trial was a single-blind design , involving a within-patient comparison of the two bonding systems with each patient r and omly allocated the two bonding systems for each side of the mouth ( all teeth except molars ) . The two bonding techniques used were st and ardized throughout the trial and all bracket bonding was performed by a single operator . Bonding time was recorded using a digital timer . The bond failure rate of a strictly paired sample was recorded at 6 and 12 months for each patient . The mean bracket bonding time per patient with the SEP was significantly less than that with the two-stage bonding system ( mean difference 24.9 seconds ; 95 per cent confidence interval 22.1 - 27.7 seconds ; paired t-test P < 0.001 ) . The overall bond failure rates at 6 and 12 months with the SEP were 0.8 and 1.6 per cent , respectively , and for the two-stage etch and prime 1.1 and 3.1 per cent , respectively . At 6 months , the mean bond failure rate per patient with the SEP was 0.81 per cent and with the two-stage bonding system 0.96 per cent ( P = 0.87 ; Wilcoxon signed rank test ) . At 12 months , the mean bond failure rate with the SEP per patient was 1.54 per cent and with the two-stage bonding system 2.78 per cent ( P = 0.33 ; Wilcoxon signed rank test ) . The mean bracket bonding time with the SEP per patient was significantly shorter than that of the two-stage bonding system ( P < 0.001 ) . The difference between the overall bond failure rate and the mean bond failure rate per patient for the two bonding systems was not statistically nor clinical ly significant at 6 and 12 months ( P = 1.00 and P = 0.125 , respectively ; McNemar 's test ) At an orthodontic meeting in recent years , a colleague recounted to me that when a presenter had finished their presentation on a systematic review , the person beside leaned over and said to my colleague ‘ not another systematic review where it ’s not possible to draw any firm conclusions ’ . So an element of frustration was clear based on the screening of a large volume of evidence to arrive at such a low point for a conclusion . This , however , is now a familiar outcome for many orthodontic systematic review s. In this short editorial , I have attempted to give a brief outline of the proposed benefits of systematic review s but more importantly , to highlight , some issues we all need to bear in mind in their regard . The increasing focus on evidence -based healthcare , including orthodontics , has shunned the narrative review and spawned the systematic review . Aim ing to identify , evaluate and summarize the findings of all relevant studies on a specific topic , its exacting systematic approach should minimize bias and provide conclusions based on reliable findings . Meta-analyses of r and omized clinical trials with low risk of bias are considered the highest level of evidence available for evaluating the effects of an intervention . Systematic review s are also important tools in setting the research agenda via their recommendations for future research and authors can alert research ers to the most pertinent outcomes in clinical practice . But systematic review s like any other study type are not without their variability , both in dentistry in general and specifically in orthodontics . Large differences have also been observed in the quality of reporting of several characteristics between Cochrane and non-Cochrane systematic review s. A key question that must be asked when looking at all Cochrane review s is whether the review has been undertaken in a way to avoid bias and whether the data and results from the included studies are valid . Conclusions may be distorted if bias is introduced to the review process at any stage . For example , incomplete search ing for all relevant studies may lead to publication bias ; there is strong association between publication and studies reporting significant or positive findings in medicine and also within orthodontics . With regard to studies included within the review , these need to be assessed to ensure that they are undertaken and reported in a manner that is free of bias ( systematic error ) . Outcome reporting bias ( ORB ) may also be relevant , e.g. in a study identified as relevant to a review , where data exist on the outcome of interest but only selected findings have been given based on the results . Although systematic review s have emphasized ‘ assessment of method ological quality ’ of included studies , the Cochrane h and book recommends a focus on ‘ risk of bias assessment ’ instead . The justifications are four-fold : it targets whether the results of included studies should be credible ; despite being carried out to the highest st and ards , a study may have risk of bias due to , e.g. impracticality/impossibility of blinding of participants / study personnel ; some quality markers , e.g. a power calculation is unlikely to directly affect risk of bias ; it overcomes ambiguity between quality of reporting and quality of the underlying research Objective A long-term comparison of the failure rates of orthodontic brackets bonded with either a self-etching primer ( SEP ) or conventional etch and primer ( AE ) . Design Prospect i ve r and omized controlled clinical trial . Setting UK district general hospital with one operator , 2003–6 . Participants Hospital waiting list patients needing fixed appliances ( n=60 ) . Method  Experimental ( SEP ) group patients ( n=30 ) received pre-adjusted edgewise brackets ( n=438 ) bonded with Transbond Plus following manufacturer 's instructions .  Control ( AE ) group patients ( n=30 , brackets n=433 ) were bonded using a 15-second conventional etch and primer ( Transbond XT ) . In both groups brackets were light-cured for 20 seconds . First-time bond failures were recorded with the time of failure . Bracket bonding time was recorded . All patients were followed to the end or discontinuation of treatment . Results Bracket failure rates : SEP=4.8 % , AE=3.5 % , P=0.793 . Mean placement time per bracket ( seconds ) : SEP=75.5 ( ±6.7 ; 95 % CI=72.9 , 78.0 ) , AE=97.7 ( ±9.1 ; 95 % CI=94.3 , 101.2 ) P=0.000 . Conclusion There was no difference in the failure rates of brackets bonded with either Transbond Plus SEP or conventional AE using Transbond XT paste . Bonding with SEP was significantly faster than using conventional AE INTRODUCTION Self-etching primers ( SEP ) have simplified the orthodontic bonding process , but questions have arisen regarding their reliability and efficiency . The goal of this study was to assess the importance of a pumice prophylaxis before bonding in reducing bond failures . METHODS Thirty orthodontic patients volunteered to participate in this prospect i ve clinical trial . A split-mouth design was used ; in each patient , 1 quadrant was r and omly assigned to the pumice prophylaxis experimental group and the contralateral quadrant to the nonpumice group . A total of 508 teeth were bonded with SEP ( Transbond Plus ; 3 M Unitek , Monrovia , Calif ) and monitored for 3 months for bond failures . RESULTS Thirty-five failures ( 6.9 % ) were recorded , with 6 ( 2.4 % ) in the pumice group and 29 ( 11.4 % ) in the nonpumice group . Chi-square analysis was used to compare bond failures as a total number between groups and also as the number of patients who experienced bond failures with each method . Statistically significant differences were found both in the total number of bond failures ( P < .001 ) and in the number of patients with bond failures between groups ( P < .01 ) . A significantly lower and clinical ly acceptable bond failure rate was demonstrated with Transbond Plus SEP after pumice prophylaxis . CONCLUSIONS This study produced strong evidence suggesting the need for pumice prophylaxis when using SEP for orthodontic bonding INTRODUCTION The purpose of this clinical trial was to evaluate over a 12-month period the performance of a self-etching system ( SEP ) ( Transbond Plus SEP , 3 M Unitek , Monrovia , Calif ) compared with a conventional multi-step system ( TBXT ) ( Transbond XT , 3 M Unitek ) . METHODS Twenty-eight r and omly selected patients were included in this study . They were r and omly assigned to either the TBXT or the SEP group . A total of 548 brackets were bonded according to the manufacturer 's instructions with Transbond XT adhesive paste ( 3 M Unitek ) . The survival rates of brackets were estimated with the Kaplan-Meier analysis . Bracket survival distributions for bonding procedure , tooth location , dental arch , and patient sex were compared with the log-rank test . RESULTS The failure rates of the TBXT and SEP groups were 4.78 % and 6.88 % , respectively . No significant differences in the survival rates were observed between the bonding procedures ( P = 0.311 ) . When tooth location , dental arch , and sex were analyzed , only tooth location was significant . Posterior brackets were more likely to fail than anterior brackets ( P = 0.013 ) . CONCLUSIONS Both systems had low bond failure rates and are adequate for orthodontic bonding needs
target: There was insufficient evidence to assess the effect of bonding modality on demineralization rates .
  CONCLUSIONS There is weak evidence indicating higher odds of failure with self-etch primer than acid etch over 12 months in orthodontic patients , and there is strong evidence that a self-etch primer is likely to result in a modest time savings ( 8 minutes for full bonding ) compared with acid etch
background: INTRODUCTION The use of self-etch primers has increased steadily because of their time savings and greater simplicity ; however , overall benefits and potential disadvantages and harms have not been assessed systematic ally .
  In this study , we review ed r and omized controlled trials to assess the risk of attachment failure , bonding time , and demineralization adjacent to attachments between 1-stage ( self-etch ) and 2-stage ( acid etch ) bonding in orthodontic patients over a minimum follow-up period of 12 months .