title: Design and Validity of Randomized Controlled Dental Restorative Trials Clinical evaluation of the posterior composite Quixfil in class I and II cavities: 4-year follow-up of a randomized controlled trial. Composite resin restoration and postoperative sensitivity: clinical follow-up in an undergraduate program. Randomized 3-year clinical evaluation of Class I and II posterior resin restorations placed with a bulk-fill resin composite and a one-step self-etching adhesive. Two-year clinical performance of sonic-resin placement system in posterior restorations. Effect of posterior resin composite placement technique on the resin-dentin interface formed in vivo. Resin composite class I restorations: a 54-month randomized clinical trial. A prospective, randomized, double-blind clinical trial of one nano-hybrid and one high-viscosity bulk-fill composite restorative systems in class II cavities: 12 months results A six-year prospective randomized study of a nano-hybrid and a conventional hybrid resin composite in Class II restorations. Clinical performance of the posterior composite QuiXfil after 3, 6, and 18 months in Class 1 and 2 cavities. [CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials (Chinese version)]. Three-year results of a randomized controlled clinical trial of the posterior composite QuiXfil in class I and II cavities A practice-based, randomized, controlled clinical trial of a new resin composite restorative: one-year results. Bulk‐filled posterior resin restorations based on stress‐decreasing resin technology: a randomized, controlled 6‐year evaluation Bulk dentine replacement versus incrementally placed resin composite: A randomised controlled clinical trial. Influence of Adhesive Type and Placement Technique on Postoperative Sensitivity in Posterior Composite Restorations.
abstract: Background : The evidence stemming from trials on restorative material s is shaped not only by trial findings , but also trial design and validity . We aim ed to evaluate both aspects in r and omized controlled dental restorative trials published from 2005–2015 . Methods : Using systematic review methodology , we retrieved trials comparing  restorative or adhesive dental material s. Two authors independently assessed design , risk of bias , registration status , and findings of trials . Descriptive and regression analyses were performed . Results : 114 studies on 15,321 restorations placed mainly in permanent teeth of 5232 patients were included . Per trial , the median number of patients was 37 ( 25th/75th percentiles : 30/51 ) . Follow-up was 24 ( 20/48 ) months . Seventeen percent of trials reported on sample size calculations , 2 % had been registered . Most trials ( 90 % ) used US Public Health Service ( USPHS ) criteria , and had a high risk of bias . More recent trials were more likely to have been registered , to have reported on sample size calculations , to be of low risk of bias , and to use other than USPHS- criteria . Twenty-three percent of trials yielded significant differences between groups . The likelihood of such differences was significantly increased in older studies , studies with potential reporting bias , published in journals with high impact factor ( > 2 ) , longer follow-up periods , and not using USPHS- criteria . Conclusions : The majority of dental restorative trials published from 2005–2015 had limited validity . Risk of bias decreased in more recent trials . Future trials should aim for high validity , be registered , and use defined and appropriate sample sizes , follow-up periods , and outcome measures PURPOSE This longitudinal r and omized controlled clinical trial evaluated direct composite restorations for clinical acceptability as posterior restoratives in single- or multi-surface cavities and provides a survey of the 4-year results . MATERIAL S AND METHODS Three dentists placed 46 Quixfil ( Xeno III ) and 50 Tetric Ceram ( Syntac Classic ) composite restorations in stress-bearing Class I and II cavities in first or second molars ( 43 adult patients ) . Clinical evaluation was performed at baseline and after 4 years by 2 other dentists using modified USPHS criteria . At the last recall period , 37 Quixfil and 46 Tetric Ceram restorations  were assessed . RESULTS A total of 89.2 % of Quixfil and 97.8 % of Tetric Ceram posterior composites were assessed to be clinical ly excellent or acceptable with predominating alfa scores . Up to the 4-year recall , four Quixfil restorations failed because of bulk fracture , partial tooth fracture ( 2x ) and postoperative symptoms . One Tetric Ceram restoration was lost due to problems with tooth integrity . No significant differences between the two composites could be detected at 4 years for any of the evaluated clinical criteria ( p > 0.05 ) . The comparison of restoration performance with time within both groups yielded a significant increase in marginal discoloration and decrease in marginal integrity for both material s. After 4 years , small restorations exhibited significantly less marginal discoloration than large restorations . CONCLUSION Clinical assessment of stress-bearing Quixfil and Tetric Ceram posterior composite restorations showed good clinical results with predominantly alfa scores for both material OBJECTIVES To analyze the relationship between the cavity depth and liners with postoperative sensitivity of  resin composite restorations .  METHODS A clinical follow-up was conducted on 319 resin composite restorations made in the final year of an undergraduate program over a 3-year period . Along with the analyses of cavity type , cavity depth , type of pulpal protection and the material s used , the postoperative sensitivity was also examined on each restoration . RESULTS Thirty-nine percent of the restorations had no protective layer ( Group 1 ) . As the depth of the prepared cavities increased , the restorations received one of the three pulpal protection methods ; a calcium hydroxide base ( Group 2 ) , glass ionomer cement ( Group 3 ) , or protection with a calcium hydroxide base in combination with glass ionomer cement ( Group 4 ) . The incidence of postoperative sensitivity showed no significant difference among Groups 1 , 2 and 3 , but was significantly lower in Group 1 than in Group 4 . The restorations made in shallow and medium depth cavities demonstrated significantly less-postoperative sensitivity than those made in deep cavities . The newer generation dentine-bonding agents showed a significantly lower incidence of postoperative sensitivity than the early generation group . CONCLUSIONS Postoperative sensitivity in resin  composite restorations was not related to the absence of protective layers but increased with the depth of cavities restored with the resin composite . The type of dentine-bonding agents could also be responsible for postoperative sensitivity PURPOSE To evaluate the 3-year clinical durability of the flowable bulk-fill resin composite SDR in Class I and Class II restorations . MATERIAL S AND METHODS Thirty-eight pairs of Class I and 62 pairs of Class II restorations were placed in 44 male and 42 female patients ( mean age 52.4 years ) . Each patient received at least two extended Class I or Class II restorations that were as similar as possible . In all cavities , a one-step self-etching adhesive ( XenoV+ ) was applied . One of the cavities of each pair was r and omly assigned to receive the flowable bulk-fill resin composite SDR in increments up to 4 mm as needed to fill the cavity 2 mm short of the occlusal cavosurface . The occlusal part was completed with an ormocer-based nanohybrid resin composite ( Ceram X mono+ ) . In the other cavity , only the resin composite CeramX mono+ was placed in 2 mm increments . The restorations were evaluated using slightly modified USPHS criteria at baseline and then annually for 3 years . Caries risk and bruxing habits of the participants were estimated . RESULTS No post-operative sensitivity was reported . At the 3-year follow-up , 196 restorations - 74 Class I and 122 Class II - were evaluated . Seven restorations failed ( 3.6 % ) , 4 SDR-CeramX mono+ and 3 CeramX mono+ only restorations , all of which were Class II . The main reason for failure was tooth fracture , followed by resin composite fracture . The annual failure rate ( AFR ) for all restorations ( Class I and II ) was 1.2 % for the bulkfilled restorations and 1.0 % for the resin composite-only restorations ( p > 0.05 ) . For the Class II restorations , the AFR was 2.2 % and 1.6 % , respectively . CONCLUSION The 4-mm bulk-fill technique showed good clinical effectiveness during the 3-year follow-up OBJECTIVE The objective of this split-mouth r and omized controlled study was to compare the 2-year clinical performance of two restorative techniques and material s for posterior permanent carious teeth . METHOD AND MATERIAL S After signing informed consent , 30 patients aged between 7 and 16 received two Class 1 restorations on cavities on permanent first or second molar teeth performed with one of two systems : incrementally placed conventional posterior composite resin ( Herculite Ultra , Kerr ) , and sonic-resin placement system ( SonicFill , Kerr ) with single-component self-etch adhesive system ( Kerr ) according to the manufacturers ' directions . Two blinded observers evaluated the restorations at three times ( baseline , and after 1 and 2 years ) according to the US Public Health Service modified criteria . Kruskal-Wallis test and Mann-Whitney U-test were used to compare the clinical performance of the restorative systems . RESULTS The restorative systems showed similar clinical performance at 2 years . At the end of 2 years in both groups , one restoration 's marginal staining Alpha ratings decreased . In the same period , two restorations in the conventional group and one in the SonicFill group received Bravo ratings for color match and surface roughness scorings . CONCLUSION The sonic-resin placement system demonstrated similar results to incrementally placed conventional composite resin in terms of clinical success . Considering the advantages of providing up to 5 mm in a single layer , and the adjustability of the viscosity , bulk-fill composite restorations seem to be a good alternative to posterior Class 1 composite restorations . CLINICAL RELEVANCE This study suggests that a new dental material for bulk-fill technology exhibits similar clinical success to incrementally placed composite resin OBJECTIVE The aim of this study was to evaluate the morphology of the resin-dentin interface formed in vivo with two posterior resin composite placement techniques ( incremental and bulk ) . METHOD AND MATERIAL S After approval from the patients , 12 Class II cavities with margins in enamel ( 2.5 x 2.5 x 4.5 mm ) were prepared in caries-free premolars scheduled to be extracted for orthodontic reasons ( n = 6 ) . The cavities were restored with Single Bond + Filtek P60 as a bulk condensable technique or Single Bond + Filtek Z250 as an oblique incremental technique . After 1 week , the teeth were extracted with minimal trauma to the restored area . After the teeth were sectioned , a polyvinyl siloxane impression was taken from the resin-dentin interface to control for artifacts created during preparation for scanning electron microscopy . The specimens were subsequently processed for and observed under a scanning electron microscope to assess gap formation . RESULTS The mean percentage of gap formation was 6.1 % for teeth restored with the incremental placement technique and 18.7 % for teeth restored with the bulk placement technique . The difference was statistically significant . CONCLUSION The incremental placement of posterior resin composites may still provide better seal than the new bulk condensable technique The objective of this longitudinal clinical r and omized trial was to evaluate the clinical performance of a nanofilled and a nanohybrid resin composite in Class I occlusal restorations of posterior teeth over the course of 54 months . Forty-one adolescents participated in the study . The teeth were restored with Adper Single Bond 2 ( 3 M ESPE ) and nanofilled ( Filtek Z350 , 3 M ESPE ) , nanohybrid ( Esthet-X , Dentsply ) and microhybrid Filtek Z250 ( 3 M ESPE ) used as a control . After 54 months , the restorations were evaluated in accordance with the modified United States Public Health Service criteria . The McNemar and Friedman tests were used for statistical analysis , at a level of significance of 5 % . Five failed restorations were observed during the follow-up . A change to unacceptable restoration occurred for one Esthet-X , two Filtek Z350 , and two Filtek Z250 restorations , which received the clinical ly unacceptable score , Charlie , for both anatomic form and marginal adaptation . Secondary caries and postoperative sensitivity occurred in one Filtek Z250 and one Filtek Z350 restoration . When the five evaluation periods ( baseline and six , 12 , 30 , and 54 months ) were compared , significant differences were found in the marginal adaptation of Filtek Z250 and Filtek Z350 . Significant differences in the roughness criteria ( p=0.005 ) were also observed when the three composites were compared after 54 months ( Filtek Z350 > Filtek Z250 > Esthet-X ) , always within clinical ly acceptable limits . The material s investigated showed acceptable clinical performance for Class I restoration after 54 months . Long-term reevaluations are necessary for a more detailed analysis of these composites Background : Recently , manufacturers have introduced bulk-fill composite resins that reportedly can be placed in increments of 4 mm or greater . Objective : The purpose of this article was to report the results of 12 months prospect i ve r and omized clinical trial that evaluated the clinical performance of one high-viscosity bulk-fill composite resin in Class II cavities of posterior teeth . Material s and Methods : Thirty-four participants had at least two Class II cavities included the study . Class II cavities restored with either a Tetric EvoCeram bulk-fi fill or universal nano-hybrid resin composite ( Tetric EvoCeram ) . A total of 74 restorations ( 37 with each material ) on 34 patients were placed according to the manufacturers ' instructions by one calibrated operator . Results : Seventy restorations were evaluated after 12 months evaluation period . No postoperative sensitivity , anatomic form , retention , and secondary caries were observed after 6 and 12 months . Regarding the items color match , marginal discoloration , and marginal adaptation , the statistical analysis did not detect any statistical significance between two material s ( P > 0.05 ) . Conclusion : After 12 months of clinical service , all restorations evaluated for both material s were classified as ideal , receiving predominantly Alfa scores for all parameters analyzed . Clinical Relevance : This study presents that high-viscosity bulk-fill resin composites ( RCs ) perform just as well as nano-hybrid RCs with the 2 mm RC layering technique , therefore could be alternative to conventional nano-hybrid RCs OBJECTIVE The objective of this 6 year prospect i ve r and omized equivalence trial was to evaluate the long-term clinical performance of a new nano-hybrid resin composite ( RC ) in Class II restorations in an intraindividual comparison with its well-established conventional hybrid RC predecessor . METHODS Each of 52 participants received at least two , as similar as possible , Class II restorations .  The cavities were chosen at r and om to be restored with an experimental nano-hybrid RC ( Exite/Tetric EvoCeram ( TEC ) ; n=61 ) and a conventional hybrid RC ( Exite/Tetric Ceram ( TC ) ; n=61 ) . The restorations were evaluated with slightly modified USPHS criteria at baseline and then annually during 6 years . RESULTS Two patient drop outs with 4 restorations ( 2TEC , 2TC ) were registered during the follow-up . A prediction of the caries risk showed that 16 of the evaluated 52 patients were considered as high risk patients . Eight TEC ( 2 P , 6 M ) and 6 TC ( 2P , 4 M ) restorations failed during the 6 years . The main reason of failure was secondary caries ( 43 % ; including the failure fracture+ secondary caries it increases to 57.1 % ) . 63 % of the recurrent caries lesions were found in high caries risk participants . The overall success rate at six years was 88.1 % . No statistical significant difference was found in the overall survival rate between the two investigated RC . SIGNIFICANCE The nano-hybrid RC showed good clinical performance during the 6 year evaluation , comparable to the well-established conventional hybrid RC OBJECTIVE This longitudinal r and omized controlled clinical trial evaluated direct composite restorations for clinical acceptability of posterior restoratives in single- or multisurface cavities and provided a preliminary survey of the 3- , 6- , and 18-month results . METHOD AND MATERIAL S Three clinicians placed 46 QuiXfil ( Xeno III ; Dentsply DeTrey ) and 50 Tetric Ceram ( Syntac Classic ; Vivadent ) composite restorations in stress-bearing Class 1 and 2 cavities in first or second molars ( 43 adult patients ) . Clinical evaluation was performed at baseline and after 3 , 6 , and 18 months by 2 other clinicians using modified US Public Health Service criteria . At the final recall period , 45 QuiXfil and 49 Tetric Ceram restorations were assessed . RESULTS A total of 97.8 % of QuiXfil and 100 % of Tetric Ceram posterior composites were assessed to be clinical ly excellent or acceptable with predominating Alpha scores . At the 18-month recall , 1 QuiXfil restoration had failed because of bulk fracture . No significant differences between either composite could be detected at 18 months for all evaluated clinical criteria ( P > .05 ) . Small QuiXfil restorations exhibited significantly less marginal discoloration ( P = .003 ) and better restoration integrity ( P = .008 ) than large restorations . The comparison of restoration performance with time within both groups yielded a significant increase in marginal discoloration for QuiXfil ( P = .011 ) and significant deterioration for anatomic form at the marginal step for Tetric Ceram ( P = .011 ) . However , both changes were only effects of scoring shifts from Alpha to Bravo . CONCLUSION Clinical assessment of stress-bearing QuiXfil and Tetric Ceram posterior composite restorations exhibited for both material s good clinical results with predominating Alpha scores The CONSORT statement is used worldwide to improve the reporting of r and omised controlled trials . Kenneth Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating experience . To encourage dissemination of the CONSORT 2010 Statement , this article is freely accessible on bmj.com and will also be published in the Lancet , Obstetrics and Gynecology , PLoS Medicine , Annals of Internal Medicine , Open Medicine , Journal of Clinical Epidemiology , BMC Medicine , and Trials This longitudinal r and omized controlled clinical trial evaluated direct composite restorations  for clinical acceptability as posterior restoratives in single- or multi-surface cavities and provides a survey of the 3-year results . Three dentists placed 46 QuiXfil ( Xeno III ) and 50 Tetric Ceram ( Syntac Classic ) composite restorations in stress-bearing class I and II cavities in first or second molars ( 43 adult patients ) . Clinical evaluation was performed at baseline and after 3 years by two other dentists using modified US Public Health Service criteria . At the last recall period , 40 QuiXfil and 46 Tetric Ceram restorations  were assessed . A total of 92.5 % of QuiXfil and 97.8 % of Tetric Ceram posterior composites were assessed to be clinical ly excellent or acceptable with predominating alpha scores . Up to the 3-year recall , three QuiXfil restorations failed because of bulk fracture , partial tooth fracture , and postoperative symptoms . One Tetric Ceram restoration was lost due to problems with tooth integrity . No significant differences between both composites could be detected at 3 years for all evaluated clinical criteria ( p > 0.05 ) . The comparison of restoration performance with time within both groups yielded a significant increase in marginal discoloration ( p = 0.007 ) and deterioration of marginal integrity ( p = 0.029 ) for QuiXfil and significant increase in marginal discoloration ( p = 0.009 ) for Tetric Ceram . However , both changes were mainly effects of scoring shifts from alpha to bravo . Clinical assessment of stress-bearing QuiXfil and Tetric Ceram posterior composite restorations exhibited for both material s good clinical results with predominating alpha scores This study evaluated the performance of a low-shrinking resin composite compared with an amalgam for restoration of Class I and II cavities of moderate size in posterior teeth in a general practice setting . Fifty-two pairs of test and control restorations were placed in 49 patients . Clinical evaluations and assessment s of replica models were carried out at baseline , six months and one year . Patients recorded their level of satisfaction with the restorations by means of  visual analog scales . Apart from one control restoration that failed due to a fractured cusp , all of the restorations review ed at six months and one year were intact with no unacceptable scores for any of the evaluation criteria . It was concluded that the resin composite evaluated , when used in conjunction with the recommended adhesive system , may be an appropriate alternative to amalgam in the restoration of posterior teeth over one year in clinical service This r and omized study evaluated a flowable resin composite bulk-fill technique in posterior restorations and compared it intraindividually with a conventional 2-mm resin composite layering technique over a 6-yr follow-up period . Thirty-eight pairs of Class II restorations and 15 pairs of Class I restorations were placed in 38 adults . In all cavities a single-step self-etch adhesive ( Xeno V ) was applied . In the first cavity of each pair , the flowable resin composite ( SDR ) was placed , in bulk increments of up to 4 mm . The occlusal part was completed with a layer of nanohybrid resin composite ( Ceram X mono ) . In the second cavity of each pair , the hybrid resin composite was placed in 2-mm increments . The restorations were evaluated using slightly modified US Public Health Service ( USPHS ) criteria at baseline and then annually for a time period of 6 yr . After 6 yr , 72 Class II restorations and 26 Class I restorations could be evaluated . Six failed Class II molar restorations , three in each group , were observed , result ing in a success rate of 93.9 % for all restorations and an annual failure rate ( AFR ) of 1.0 % for both groups . The AFR for Class II and Class I restorations in both groups was 1.4 % and 0 % , respectively . The main reason for failure was resin composite fracture OBJECTIVE This r and omized controlled clinical trial compared two techniques and material s for restoring carious teeth-Bulk  dentine replacement versus incremental placement of a hybrid posterior resin composite material in terms of patient comfort ( post operative sensitivity and tenderness on biting ) . MATERIAL AND METHODS Seventy-two carious teeth were r and omized to one of two treatment groups : Group A-were restored with a bulk dentine replacement material or Group B-restored with incrementally placed hybrid composite . Patients were followed up by way of a structured phone call at day 2 and day 7 post-operatively . Patients reporting discomfort at day 7 were subsequently followed up on days 14 , and 30 . RESULTS All patients were followed up . At day 2 , 18/72 restored teeth had post-operative sensitivity ; this figure fell to 10/72 at day 7 . A Chi squared test revealed that at day 2 a greater level of sensitivity was reported by patients in Group A ( P=0.029 ) . However , at day 7 there was no statistically significant difference between the two groups in terms of sensitivity ( P=0.453 ) . 8/72 and 6 /72 teeth had tenderness to biting at days 2 and 7 respectively . A Chi squared test revealed no statistically significant difference between the two groups in terms of tenderness on biting at any time period ( P=0.722 ) . Interestingly , Class I cavities were found to be more tender on biting than Class II cavities . At day 30 2/72 teeth exhibited sensitivity and none of the teeth exhibiting tenderness on biting . CONCLUSION At day 7 there was no significant difference between the two groups in terms of postoperative sensitivity and tenderness on biting PURPOSE This double blind , r and omized clinical trial compared the postoperative sensitivity of the placement technique ( incremental and bulk fill ) in posterior composite resin restorations bonded with two different adhesive strategies ( self-etch and etch- and -rinse ) . METHODS Posterior dental cavities of 72 participants ( n=236 ) , with a cavity depth of at least 3 mm , were r and omly divided into four groups . The restorations were bonded using either the etch- and -rinse Tetric N-Bond ( Ivoclar Vivadent ) or the self-etch Tetric N-Bond SE ( Ivoclar Vivadent ) . The composite resin Tetric N-Ceram Bulk Fill ( Ivoclar Vivadent ) was placed either incrementally or using the bulk-fill technique . Two experienced and calibrated examiners evaluated the restorations using World Dental Federation criteria after one week of clinical service . Spontaneous postoperative sensitivity was assessed using a 0 - 4 numerical rating scale and a 0 - 10 and 0 - 100 visual analog scale up to 48 h after the restorative procedure and after one week . RESULTS The risk ( p>0.49 ) and intensity of spontaneous postoperative sensitivity ( p>0.38 ) was not affected by the adhesive strategy or the filling technique . The overall risk of postoperative sensitivity was 20.3 % ( 95 % confidence interval 15.7 - 25.9 ) and typically occurred within 48 hours after the restorative procedure . CONCLUSIONS The overall risk of immediate postoperative sensitivity was 20.3 % and was not affected by either the adhesive strategy ( etch- and -rinse/self-etch ) or the filling technique ( incremental/ bulk )
target: Conclusions The present systematic review and meta- analysis indicate similar clinical performances of bulk-fill and conventional resin composites over a follow-up period of 12 to 72 months .
  Clinical significance Based on the results of this study , the bulk-fill resin composites could be an alternative for direct restorations in posterior teeth .
background: Objectives The purpose of this systematic review was to compare the clinical performance of bulk-fill resin composites with conventional resin composites used for direct restorations of posterior teeth .
  The research question was “ Do bulk-fill resin composites have a clinical performance comparable to conventional resin composites in posterior restorations ? ”