title: Direct Pulp-Capping with Calcium Enriched Mixture in Primary Molar Teeth: A Randomized Clinical Trial Treatment Outcomes of Primary Molars Direct Pulp Capping after 20 Months: A Randomized Controlled Trial Clinical and radiological evaluation of calcium sulfate as direct pulp capping material in primary teeth. Blinding in randomised trials: hiding who got what Adequacy and reporting of allocation concealment: review of recent trials published in four general medical journals Clinical and histological evaluation of white ProRoot MTA in direct pulp capping. Clinical and radiographic evaluation of adhesive pulp capping in primary molars following hemostasis with 1.25% sodium hypochlorite: 2-year results. Comparison of CaOH with MTA for Direct Pulp Capping Coronal microleakage of two root-end filling materials using a polymicrobial marker. Efficacy of EMD versus calcium hydroxide in direct pulp capping of primary molars: a randomized controlled clinical trial. The ethical problems with sham surgery in clinical research. Structured Abstracts: Do they Improve Citation Retrieval from Dental Journals?
abstract: INTRODUCTION The aim of this trial was to compare clinical and radiographic success rates of direct pulp capping ( DPC ) using a novel bio material called Calcium Enriched Mixture ( CEM ) cement versus Mineral Trioxide Aggregate ( MTA ) in primary molar teeth . MATERIAL S AND METHODS In this r and omized clinical trial 42 deciduous molars in 21 patients who had at least two teeth requiring DPC , were treated . The enrolled patients were between 5 - 8 years . The molar teeth were r and omly divided into two experimental groups . Patients and operators were blinded . The teeth were anaesthetized , caries were removed and after pinpoint exposure of dental pulp , haemostasis was achieved . The exposure points were capped with MTA or CEM cement . All teeth were restored with amalgam . Patients were recalled for the 6-month follow up . Statistical analysis was carried out using McNemar test . RESULTS Thirty-eight teeth were available for follow up ( 19 in each group ) . The radiographic evaluations did not show failure in experimental groups ; however , in clinical examinations one sinus tract was found in CEM cement group . Clinical success rates in CEM cement and MTA groups were 94.8 % and 100 % , respectively . Dentinal bridge formation was not observed in the two experimental groups . CONCLUSION There is no significant difference between treatment outcomes of direct pulp capping with either CEM cement or MTA ; therefore , both bio material s can be used successfully for DPC in primary molar teeth Introduction The aim of this r and omized controlled trial was to compare the radiographic and clinical success rates of direct pulp capping ( DPC ) using ProRoot mineral trioxide aggregate ( MTA ) or calcium enriched mixture ( CEM ) . Methods and Material s A total of 42 symptom-free carious vital primary molars ( 21 pairs ) were selected in this split mouth trial and r and omly pulpotomized in two experimental groups . Pinpoint pulp exposures were covered by the same blinded operator with MTA or CEM , and then restored by amalgam .  Radiographic and clinical successes were evaluated at 20 month follow-up . Data were statistically analyzed using McNemar test . Results Nineteen patients were available for 20-month follow-up ; only one failed tooth was extracted in the CEM group . All available teeth were symptom-free , however , the final evaluated success rate was 89 % in CEM ( CI 95 % : 0.82 - 0.96 ) and 95 % in MTA ( CI 95 % : 0.85 - 1 ) groups without statistical difference ( P=0.360 ) . Worst case scenario was applied for missing value analysis ; assuming that the 2 lost cases in CEM group had failed and the only lost case in MTA group was due to treatment success , as a result the success of CEM and MTA were 81 % ( CI 95 % : 0.72 - 0.90 ) and 95 % ( CI 95%:0.85 - 1 ) , respectively , with no statistical difference ( P=0.078 ) . In the reverse scenario , the success of MTA and CEM were 86 % ( CI 95 % : 0.78 - 0.94 ) and 90 % ( CI 95 % : 0.82 - 0.98 ) , respectively ; again with no statistical difference ( P=0.479 ) . Conclusion Effectiveness of MTA and CEM bio material s for primary molars ’ DPC was similar ; CEM can be a suitable alternative for MTA AIM To evaluate the clinical and radiological response of primary molars to direct pulp capping with calcium sulfate hemihydrate . MATERIAL S AND METHODS Forty primary molar teeth in 40 healthy children aged 5 - 9 years were treated by direct pulp capping . Teeth were r and omly assigned to two groups ( n=20 ) according to material used for capping , as follows : Group 1 : calcium hydroxide cement ( Dycal ) ; Group 2 : calcium sulfate hemihydrate ( Dentogen ) . All teeth were restored with a conventional glass ionomer base ( Fuji IX ) and amalgam . RESULTS After 12 months , the overall success rate of direct pulp capping was approximately 75 % ( 24/32 teeth , excluding exfoliations ) . The success rate did not differ significantly between calcium hydroxide and calcium sulfate hemihydrate treatment . CONCLUSION Calcium sulfate hemihydrate was found to be as successful as calcium hydroxide for direct pulp capping of primary molars with Class I cavities . Further histological studies are needed to support these findings Blinding embodies a rich history spanning over two centuries . Most research ers worldwide underst and blinding terminology , but confusion lurks beyond a general comprehension . Terms such as single blind , double blind , and triple blind mean different things to different people . Moreover , many medical research ers confuse blinding with allocation concealment . Such confusion indicates misunderst and ings of both . The term blinding refers to keeping trial participants , investigators ( usually health-care providers ) , or assessors ( those collecting outcome data ) unaware of the assigned intervention , so that they will not be influenced by that knowledge . Blinding usually reduces differential assessment of outcomes ( information bias ) , but can also improve compliance and retention of trial participants while reducing biased supplemental care or treatment ( sometimes called co-intervention ) . Many investigators and readers naïvely consider a r and omised trial as high quality simply because it is double blind , as if double-blinding is the sine qua non of a r and omised controlled trial . Although double blinding ( blinding investigators , participants , and outcome assessors ) indicates a strong design , trials that are not double blinded should not automatically be deemed inferior . Rather than solely relying on terminology like double blinding , research ers should explicitly state who was blinded , and how . We recommend placing greater credence in results when investigators at least blind outcome assessment s , except with objective outcomes , such as death , which leave little room for bias . If investigators properly report their blinding efforts , readers can judge them . Unfortunately , many articles do not contain proper reporting . If an article cl aims blinding without any accompanying clarification , readers should remain sceptical about its effect on bias reduction In r and omised controlled trials , allocation concealment ( separating the process of r and omisation from the recruitment of participants ) is important for rigorously design ed trials.1–4 In 1996 many major medical journals adopted the CONSORT statement ( whereby research ers have to include a short checklist of essential items and a flow diagram when reporting trials),5 and this move encouraged the reporting of allocation concealment . We review ed the prevalence of adequate allocation concealment and its association with the statistical significance of trial results . We search ed by h and four general medical journals ( the BMJ , JAMA , the Lancet , and the New Engl and Journal of Medicine ) to identify r and omised controlled trials published from January 2002 to December 2002 . We included articles if the authors reported that participants were r and omised and if the trial was published as a full report with the results of the main analyses . We categorised articles according to whether allocation concealment was adequate ( the person who executed the allocation sequence was different from the person who recruited PURPOSE To evaluate the clinical , radiographical and histological findings in human third molars in which mechanical pulp exposures were capped with white ProRoot mineral trioxide aggregate ( WMTA ) . METHODS Forty-eight human third molars , caries-free or with incipient caries , scheduled to be extracted , were used and r and omly divided into two groups : Group A : ( n= 24 ) received WMTA and control Group B : ( n= 24 ) received chemical set calcium hydroxide ( Dycal ) . The teeth were isolated with rubber dam and Class I cavities prepared . Pulp exposure was performed using a sterile diamond bur and confirmed by frank bleeding . A sterile cotton pellet dipped in saline solution was placed over the exposure for 60 seconds . The preparation was then lightly rinsed with water and gently air-dried . WMTA or CH was placed over the exposure site followed by a small amount of a light-cured compomer . After etching with 35 % phosphoric acid gel for 15 seconds , rinsing and blot drying , Prime and Bond NT adhesive was applied and light-cured . The cavity was then restored with a resin composite and light-cured . Evaluations were performed by phone after 7 days and clinical ly at 30 + /- 5 and 136 + /- 24 days , using st and ardized tests and radiographs . The teeth were extracted after 136 + /- 24 days ; the roots were cut + /- 4 - 5 mm from the apex to allow for rapid fixation in 10 % neutral buffered formalin . They were then processed for routine histological evaluation , embedded in paraffin , sectioned and stained with hematoxylin and eosin and Brown and Brenn for recognition of bacteria . Statistical analyses were performed using a Mann-Whitney U-test , a Chi-square test , a Fisher 's exact test and an ANOVA . RESULTS No significant differences in post-operative sensitivity were reported after 7 days between the two material s ( P > 0.05 ) . Clinical examination demonstrated no significant differences at 30 + /- 5 days ( P > 0.05 ) and at 136 + /- 24 days ( P > 0.05 ) . Histological findings : 45 of 48 teeth were suitable for microscopic evaluation ( 22 with WMTA and 23 with CH ) . Twenty from the WMTA and 18 from the CH group had developed a bridge . No statistically significant differences were found for superficial and deep inflammatory cell response ( P > 0.05 ) , presence of a dentin bridge ( P > 0.01 ) , and pulp vitality ( P > 0.01 ) , between WMTA and calcium hydroxide . A statistically significant difference was found for the diameter of exposure ( P < or = 0.05 ) between WMTA ( x= 0.35 + /- 0.19 mm ) and CH ( x= 0.25 + /- 0.09 mm ) . Only a minimal association between clinical and histological findings could be established for either material PURPOSE To evaluate , prospect ively , the clinical and radiological response of primary molars , pulp-capped with calcium hydroxide and different adhesive systems  after hemorrhage control with 1.25 % sodium hypochlorite ( NaOCl ) . METHODS 100 primary molar teeth were pulp-capped in 67 children who met inclusion criteria . Hemorrhage at the exposure site was controlled with 60 seconds application of 1.25 % NaOCl . Teeth were r and omly assigned into five groups ( n=20 each ) with respect to the material /technique used for capping : ( 1 ) calcium hydroxide cement ( Dycal ) ; ( 2 ) acetone-based total-etch adhesive ( Prime&Bond NT ) ; ( 3 ) a non-rinse conditioner ( NRC ) and Prime&Bond NT ; ( 4 ) total-etching with 36 % phosphoric acid followed by Prime&Bond NT ; and ( 5 ) a self-etch adhesive system ( Xeno III ) . Teeth in Group 1 were restored with amalgam and Groups 2 - 5 with polyacid-modified resin-based composite ( Dyract AP ) . The teeth were evaluated clinical ly and radiographically for 24 months . Marginal integrity of the restorations was also recorded at recall periods using modified USPHS/Ryge criteria . RESULTS After 2 years , the overall success rate of direct pulp capping was approximately 93 % ( 78/84 teeth , excluding exfoliations ) . The Dycal and Prime&Bond NT groups did not exhibit any clinical or radiographic failure . A majority of failures were observed in teeth that received NRC and phosphoric acid pretreatments ( Groups 3 and 4 ) . Clinical symptoms were seldom associated with failed teeth . Only one tooth failed in the Xeno III group . Marginal integrity scores were not compatible with the clinical / radiographic outcome This practice -based , r and omized clinical trial evaluated and compared the success of direct pulp capping in permanent teeth with MTA ( mineral trioxide aggregate ) or CaOH ( calcium hydroxide ) .  Thirty-five practice s in Northwest PRECEDENT were r and omized to perform direct pulp caps with either CaOH ( 16 practice s ) or MTA ( 19 practice s ) . Three hundred seventy-six individuals received a direct pulp cap with CaOH ( n = 181 ) or MTA ( n = 195 ) . They were followed for up to 2 yrs at regular recall appointments , or as dictated by tooth symptoms . The primary outcomes were the need for extraction or root canal therapy . Teeth were also evaluated for pulp vitality , and radiographs were taken at the dentist ’s discretion . The probability of failure at 24 mos was 31.5 % for CaOH vs. 19.7 % for MTA ( permutation log-rank test , p = .046 ) . This large r and omized clinical trial provided confirmatory evidence for a superior performance with MTA as a direct pulp-capping agent as compared with CaOH when evaluated in a practice -based research network for up to 2 yrs ( Clinical Trials.gov NCT00812887 ) The purpose of this study was to evaluate polymicrobial coronal leakage of mineral trioxide aggregate ( MTA ) and  amalgam . There were 108 single-rooted teeth r and omly divided into 3 groups of 32 teeth each and positive and negative control groups of 6 teeth and obturated with gutta percha and either Diaket ( 3M/ESPE , Seefeld , Germany ) , AH Plus ( Dentsply , De Trey , Konstanz , Germany ) , or Ketac Endo ( 3M/ESPE ) . These groups were further divided into 2 subgroups of 16 teeth in which root ends were resected and obturated with either MTA or zinc-free amalgam . The sample s have been incorporated in a dual-chamber leakage model with a polymicrobial marker of five facultative anaerobes on the coronal part . Leakage was observing during a period of 90 days . The least leakage was found in a combination of Diaket and MTA ( 76.9 + /-14.8 days ) followed by AH Plus and MTA ( 66.1 + /- 18.7 ) , Diaket and amalgam ( 60.0 + /- 23.1 ) , AH Plus and amalgam ( 56.9 + /- 22.1 ) , and Ketac Endo and MTA ( 42.1 + /- 17.8 ) , whereas the greatest leakage was observed in the Ketac Endo and amalgam group ( 40.0 + /- 17.24 ) . Sample s filled with MTA showed significantly better sealing than sample s filled with amalgam ( p < 0.05 ) OBJECTIVE The aim was to compare the clinical and radiographic efficacy of enamel matrix derivative and self-hardening calcium hydroxide as direct pulp capping material s on decayed primary molars , with observation periods of 1 , 6 , and 12 months . STUDY DESIGN A clinical , r and omized , controlled trial was performed , following the " split-mouth " design . A total of 90 primary molars were treated . Assignation of material s and operative initial side were selected in a r and omized manner . Five outcome variables were considered : internal dentin resorption , pain , gingival sinus tract , root external resorption , and pathologic mobility . The appearance of any of these signs or symptoms was considered to be a failure of treatment . RESULTS Significant statistical or clinical differences were not found between the study groups . Two treatments were judged as failures , 1 per study group ; both occurred during the first postoperative month . CONCLUSIONS The technique used for direct pulp capping on primary molars in this study is recommended on the basis of the obtained clinical and radiographic results The recent use of sham surgery in r and omized , controlled trials raises three critical questions about research involving human subjects . The first question concerns the tension between the highest st and ard of research design and the highest st and ard of ethics.1 When these two st and ards come into conflict and research ers can not simultaneously meet both , which should prevail , and how should a balance be struck ? The second question points to ongoing uncertainties and disagreements in assessing the risks and benefits of research protocol s. When reasonable people — the members of well-established institutional review boards or the sponsors of research — disagree in their risk – benefit . . Objectives To assess whether structured abstract s improved the sensitivity , precision and yield of retrieving clinical trials , using electronic search es , for example , MEDLINE , from dental journals . Design Retrospective , observational study . Sample Clinical trials , published in six dental journals . Three that adopted structured abstract s  ( BDJ , CPJ , JO ) and three that remained unchanged ( JDR , EJO , AJODO ) between January 1995 and December 1998 ( extended to December 2002 for the JO ) . Intervention Adoption of a structured abstract format . Control Continued use of a non-structured abstract format . Method A combination of h and search ing and the Cochrane Collaboration Oral H1ealth Group 's Trials Register and /or CENTRAL were used to identify r and omised controlled trials ( RCTs ) and controlled clinical trials ( CCTs ) over the selected time period . MEDLINE was used to identify clinical trials in the selected journals over the same time period . Results There was no significant difference in the sensitivity or yield of clinical trial retrieval in journals with either abstract format over time . However , there was a significant increase in precision in journals that did not change their format ( OR=4.96 ( 95 % CI 1.18 , 20.86 ) but not those that did . There was no significant difference in the sensitivity or yield of clinical trial retrieval either before or after the change in format or precision of retrieval before the change . However , in the later period , the precision of retrieval was significantly better in journals with unstructured abstract s compared to those with structured abstract s ( OR=0.17 ( 95 % CI 0.04 , 0.7 ) . Conclusion The use of a structured abstract format does not improve the sensitivity , precision or yield of retrieval of clinical trials from MEDLINE
target: No firm evidence was reached according to trial sequential analysis .
  Conclusion There is insufficient data to recommend or refute the use of a specific material .
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