human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement aims to improve the reporting of r and omized controlled trials ( RCTs ) ; however , it lacks guidance on the reporting of patient-reported outcomes ( PROs ) , which are often inadequately reported in trials , thus limiting the value of these data . In this article , we describe the development of the CONSORT PRO extension based on the method ological framework for guideline development proposed by the Enhancing the Quality and Transparency of Health Research ( EQUATOR ) Network . Five CONSORT PRO checklist items are recommended for RCTs in which PROs are primary or important secondary end points . These recommendations urge that the PROs be identified as a primary or secondary outcome in the abstract , that a description of the hypothesis of the PROs and relevant domains be provided ( ie , if a multidimensional PRO tool has been used ) , that evidence of the PRO instrument 's validity and reliability be provided or cited , that the statistical approaches for dealing with missing data be explicitly stated , and that PRO-specific limitations of study findings and generalizability of results to other population s and clinical practice be discussed . Examples and an up date d CONSORT flow diagram with PRO items are provided . It is recommended that the CONSORT PRO guidance supplement the st and ard CONSORT guidelines for reporting RCTs with PROs as primary or secondary outcomes . Improved reporting of PRO data should facilitate robust interpretation of the results from RCTs and inform patient care Introduction Despite the widespread acceptance of conventional treatment using composite resin in primary teeth , there is limited evidence that this approach is the best option in paediatric clinics .  Atraumatic restorative treatment ( ART ) using high-viscosity glass ionomer cement has gradually become more popular because it performs well in clinical studies , is easy to h and le and is patient friendly . Therefore , the aim of this r and omised clinical trial study is to compare the restoration longevity of conventional treatment using composite resin with that of ART in posterior primary teeth . As secondary outcomes , cost-efficacy and patient self-reported discomfort will also be tested . Methods and analysis Children aged 3–6 years presenting with at least one occlusal and /or occlusal-proximal cavity will be r and omly assigned to one of two groups according to the dental treatment : ART ( experimental group ) or composite resin restoration ( control group ) . The dental treatment will be performed at a dental care trailer located in an educational complex in Barueri/SP , Brazil . The unit of r and omisation will be the child . A sample size of 240 teeth with occlusal cavities and 188 teeth with occlusal-proximal cavities has been calculated . The primary outcome will be restoration longevity , which will be clinical ly assessed after 6 , 12 , 18 and 24 months by two examiners . The duration of the dental treatment and the cost of all material s used will be considered when estimating the cost-efficacy of each treatment . Individual discomfort will be measured after each dental procedure using the Facial Scale of Wong-Baker . Ethics and dissemination This clinical trial was approved by the local ethics committee from the Faculty of Dentistry of the University of São Paulo ( registration no. 1.556.018 ) . Participants will be included after their legal guardians have signed an informed consent form containing detailed information about the research . Trial registration number www . clinical trials.gov , NCT02562456 ; Pre- results Background Scotl and has high levels of untreated dental caries in primary teeth . The Hall Technique is a simplified method of managing carious primary molars using preformed metal crowns ( PMCs ) cemented with no local anaesthesia , caries removal or tooth preparation . This study compared the acceptability of the  Hall Technique  for children , their carers , and dentists , and clinical outcomes for the technique , with conventional restorations . Methods General dental practice based , split mouth , r and omized controlled trial ( 132 children , aged 3–10 ) . General dental practitioners ( GDPs , n = 17 ) in Tayside , Scotl and ( dmft 2.7 ) placed conventional ( Control ) restorations in carious primary molars , and Hall Technique PMCs on the contralateral molar ( matched clinical ly and radiographically ) . Dentists ranked the degree of discomfort they felt the child experienced for each procedure ; then children , their carers and dentists stated which technique they preferred . The teeth were followed up clinical ly and radiographically . Results 128 conventional restorations were placed on 132 control teeth , and 128 PMCs on 132 intervention teeth . Using a 5 point scale , 118 Hall PMCs ( 89 % ) were rated as no apparent discomfort up to mild , not significant ; for Control restorations the figure was 103 ( 78 % ) . Significant , unacceptable discomfort was recorded for two Hall PMCs ( 1.5 % ) and six Control restorations ( 4.5 % ) . 77 % of children , 83 % of carers and 81 % of dentists who expressed a preference , preferred the Hall technique , and this was significant ( Chi square , p < 0.0001 ) . There were 124 children ( 94 % of the initial sample ) with a minimum follow-up of 23 months . The Hall PMCs outperformed the Control restorations  : a ) ' Major ' failures ( signs and symptoms of irreversible pulpal disease ) : 19 Control restorations ( 15 % ) ; three Hall PMCs ( 2 % ) ( P < 0.000);b ) ' Minor ' failures ( loss of restoration , caries progression ) : 57 Control restorations ( 46 % ) ; six Hall PMCs ( 5 % ) ( P < 0.000)c ) Pain : 13 Control restorations ( 11 % ) ; two Hall PMCs ( 2 % ) ( P = 0.003 ) . Conclusion The Hall Technique was preferred to conventional restorations by the majority of children , carers and GDPs . After two years , Hall PMCs showed more favourable outcomes for pulpal health and restoration longevity than conventional restorations . The Hall Technique appears to offer an effective treatment option for carious primary molar teeth . Trial registration numberCurrent Controlled Trials IS RCT N47267892 – A r and omized controlled trial in primary care of a novel method of using preformed metal crowns to manage decay in primary molar teeth : the Hall technique Background In many parts of the world , school-age children have high dental treatment needs ; however , there is often low , or no , dental care provision . Although Atraumatic Restorative Treatment ( ART ) was developed to address this , its survival rate in occluso-proximal lesions is low . An alternative , the Hall Technique ( HT ) has shown better relative outcomes for occluso-proximal lesions , but has not been directly compared to ART or tested in field setting s. This trial will compare ART and the HT for the most clinical ly- and cost-effective strategy for managing occluso-proximal lesions in primary molars , in a school setting , using low-technology and child-friendly dental techniques . Methods / Design This two-arm , parallel group , patient-r and omized controlled , superiority trial will have treatment provided in schools . Schoolchildren ( n = 124 , age 6–8 ) with at least one occluso-proximal carious primary molar lesion will have r and om allocation to treatment with ART or HT . Baseline measures and outcome data will be assessed through participant report , clinical examination and parent report/ question naires . The primary outcome is survival rate , a composite measure of absence of Minor Failures ( a defect in the restoration/crown , but not interfering with tooth health ) and Major Failures ( signs or symptoms of irreversible pulp damage , such as dental fistula/abscess , tooth fracture or failures that can not be repaired ) . Secondary outcomes are : ( 1 ) child-reported discomfort , ( 2 ) childrens ’ and ( 3 ) parents ’ concerns around dental appearance and ( 4 ) acceptability of treatments , ( 5 ) occlusal-vertical dimensions ( OVD ) changes , ( 6 ) plaque index , ( 7 ) gingival health , ( 8) decayed , missing , filled teeth in permanent teeth (DMFT)/decayed , missing , filled teeth in primary teeth ( dmft ) , ( 9 ) oral health-related- quality of life , reported by children and parents/caregivers , ( 10 ) the incremental cost-effectiveness , and ( 11 ) operator effect . A trained and calibrated examiner will evaluate the treated teeth after 1 week , then 1 , 6 , 12 , 24 and 36 months post treatment . Kaplan-Meier and Cox regression tests will be used to investigate the primary outcome . The Mann-Whitney or t test , Friedman test , paired t test or Wilcoxon test and Ordinal Logistic Regression Analysis will be used to analyze the secondary outcomes . Discussion The results of this trial will support decision-making by clinicians and policy-makers for managing occluso-proximal lesions in setting s with constrained re sources and limited dental access . Trial registration www . clinical trials.gov , NCT02569047 , registered 5 October 2015 Atraumatic restorative treatment ( ART ) and minimal intervention treatment ( MIT ) techniques were evaluated under field conditions in 5 regions of the Western Cape Province of South Africa , where caries prevalence exceeds 60 % and remains mostly untreated . The purpose of the study was to compare and evaluate results of  ART and MIT techniques in the primary dentition of 6 - 9 year-old schoolchildren using  glass-ionomer ( GI ) ( Fuji IX ) and compomer ( Dyract AP ) material s. At baseline 401 children were treated , and 1,119 restorations  placed by 5 calibrated dentists , 53 % with ART ( using h and instruments only ) and 47 % with MIT ( minimal use of slow h and -piece ) techniques . Evaluations were done with a CPI periodontal probe to measure marginal defects and to detect decay . A pain assessment for the restoration procedures indicated that 80 % of subjects experienced no pain , 18 % discomfort and slight pain , and 2 % required local anaesthetic . After one year 90.5 % of subjects and 80 % of restorations were followed up ( 11.1 % lost as a result of exfoliation ) ; of these restorations 86 % were clinical ly acceptable ( 84.1 % of the ART and 88 % of the MIT ) . With the art technique 82.7 % of GI restorations and 85.6 % , of compomer restorations were acceptable . With the MIT technique 86.5 % of GI restorations and 89.9 % of compomer restorations were acceptable . Success of restorations per region varied significantly : regions 1 and 2 - 90 % , region 3 - 80 % , region 4 - 70 % and region 5 - 95 % . There were no significant statistical differences in respect of material s or methods employed . ART and MIT techniques were well accepted as complementary caries approaches by operators . One-year results show that ART and MIT techniques were successful , substantiating its use for the primary dentition in areas with high caries prevalence . Longer-term assessment s are required OBJECTIVE To compare the level of pain among children treated according to the Atraumatic Restorative Treatment ( ART ) and the Conventional Restorative Treatment ( CRT ) .  STUDY DESIGN Forty children of both genders , 4- to 7-years old , presenting Class I cavitated dentin lesions in primary molars were r and omly allocated to 2 groups . One group ( CRT ) received conventional restorative treatment using rotary instruments , while in the other one ( ART ) h and instruments were used to perform the restorations . All children were treated by the same operator A high-viscosity glass-ionomer cement ( Fuji IX ) was used to restore the teeth in both groups . Children 's pain was measured at the end of the first restorative treatment session using the Wong-Baker FACES Pain Rating Scale ( dependent variable ) . Age , gender , treatment time and treatment group were independent variables . ANOVA and ANCOVA tests were used to analyze the data . RESULTS The CRT procedure took longer than the ART procedure ( p < 0.001 ) . Children from the ART group reported less pain than those from the CRT group ( p = 0.0037 ) . Four year olds reported more pain than 5- to 7-year olds ( p < 0.0001 ) in both groups . CONCLUSIONS Restorations placed using ART were less time consuming , children felt less pain when the ART approach was used , and younger children ( 4-years ) reported more pain than the older ones for both restorative treatments BACKGROUND More conservative techniques for managing dental caries including ' partial ' and ' no caries removal ' have been increasingly of interest . AIM To compare children 's  behaviour and pain perception , also technique acceptability ( parents and dentists ) , when approximal dentinal lesions ( ICDAS 3 - 5 ) in primary molars ( 3 - 8-year-olds ) were managed with three treatment strategies ; conventional restorations ( CR ) , hall technique ( HT ) , and non-restorative caries treatment ( N RCT ) . DESIGN Secondary care-based , three-arm parallel-group , r and omised controlled trial , with 169 participants treated by 12 dentists . OUTCOME MEASURES child 's pain perception ( Visual Analogue Scale of Faces ) ; behaviour ( Frankl scale ) ; and parents ' and dentists ' treatment opinions ( 5-point Likert scales ) . RESULTS Children showed more negative behaviour in the CR group ( 37 % ) compared to N RCT ( 21 % ) and HT ( 13 % ) ( P = 0.047 , CI = 0.41 to 0.52 ) . Pain intensity was 
    Output:
    
agent
Regarding pain , there was a trend for treatments without rotary instruments and local anesthesia to be less frequently reported as painful .
No statistical difference was found intragroup nor among treatments for OHRQoL. CONCLUSIONS Anxiety and pain are directly related with more invasive restorative treatments .
On the other h and , quality of life is not improved regardless of the restorative technique used .
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement aims to improve the reporting of r and omized controlled trials ( RCTs ) ; however , it lacks guidance on the reporting of patient-reported outcomes ( PROs ) , which are often inadequately reported in trials , thus limiting the value of these data . In this article , we describe the development of the CONSORT PRO extension based on the method ological framework for guideline development proposed by the Enhancing the Quality and Transparency of Health Research ( EQUATOR ) Network . Five CONSORT PRO checklist items are recommended for RCTs in which PROs are primary or important secondary end points . These recommendations urge that the PROs be identified as a primary or secondary outcome in the abstract , that a description of the hypothesis of the PROs and relevant domains be provided ( ie , if a multidimensional PRO tool has been used ) , that evidence of the PRO instrument 's validity and reliability be provided or cited , that the statistical approaches for dealing with missing data be explicitly stated , and that PRO-specific limitations of study findings and generalizability of results to other population s and clinical practice be discussed . Examples and an up date d CONSORT flow diagram with PRO items are provided . It is recommended that the CONSORT PRO guidance supplement the st and ard CONSORT guidelines for reporting RCTs with PROs as primary or secondary outcomes . Improved reporting of PRO data should facilitate robust interpretation of the results from RCTs and inform patient care Introduction Despite the widespread acceptance of conventional treatment using composite resin in primary teeth , there is limited evidence that this approach is the best option in paediatric clinics .  Atraumatic restorative treatment ( ART ) using high-viscosity glass ionomer cement has gradually become more popular because it performs well in clinical studies , is easy to h and le and is patient friendly . Therefore , the aim of this r and omised clinical trial study is to compare the restoration longevity of conventional treatment using composite resin with that of ART in posterior primary teeth . As secondary outcomes , cost-efficacy and patient self-reported discomfort will also be tested . Methods and analysis Children aged 3–6 years presenting with at least one occlusal and /or occlusal-proximal cavity will be r and omly assigned to one of two groups according to the dental treatment : ART ( experimental group ) or composite resin restoration ( control group ) . The dental treatment will be performed at a dental care trailer located in an educational complex in Barueri/SP , Brazil . The unit of r and omisation will be the child . A sample size of 240 teeth with occlusal cavities and 188 teeth with occlusal-proximal cavities has been calculated . The primary outcome will be restoration longevity , which will be clinical ly assessed after 6 , 12 , 18 and 24 months by two examiners . The duration of the dental treatment and the cost of all material s used will be considered when estimating the cost-efficacy of each treatment . Individual discomfort will be measured after each dental procedure using the Facial Scale of Wong-Baker . Ethics and dissemination This clinical trial was approved by the local ethics committee from the Faculty of Dentistry of the University of São Paulo ( registration no. 1.556.018 ) . Participants will be included after their legal guardians have signed an informed consent form containing detailed information about the research . Trial registration number www . clinical trials.gov , NCT02562456 ; Pre- results Background Scotl and has high levels of untreated dental caries in primary teeth . The Hall Technique is a simplified method of managing carious primary molars using preformed metal crowns ( PMCs ) cemented with no local anaesthesia , caries removal or tooth preparation . This study compared the acceptability of the  Hall Technique  for children , their carers , and dentists , and clinical outcomes for the technique , with conventional restorations . Methods General dental practice based , split mouth , r and omized controlled trial ( 132 children , aged 3–10 ) . General dental practitioners ( GDPs , n = 17 ) in Tayside , Scotl and ( dmft 2.7 ) placed conventional ( Control ) restorations in carious primary molars , and Hall Technique PMCs on the contralateral molar ( matched clinical ly and radiographically ) . Dentists ranked the degree of discomfort they felt the child experienced for each procedure ; then children , their carers and dentists stated which technique they preferred . The teeth were followed up clinical ly and radiographically . Results 128 conventional restorations were placed on 132 control teeth , and 128 PMCs on 132 intervention teeth . Using a 5 point scale , 118 Hall PMCs ( 89 % ) were rated as no apparent discomfort up to mild , not significant ; for Control restorations the figure was 103 ( 78 % ) . Significant , unacceptable discomfort was recorded for two Hall PMCs ( 1.5 % ) and six Control restorations ( 4.5 % ) . 77 % of children , 83 % of carers and 81 % of dentists who expressed a preference , preferred the Hall technique , and this was significant ( Chi square , p < 0.0001 ) . There were 124 children ( 94 % of the initial sample ) with a minimum follow-up of 23 months . The Hall PMCs outperformed the Control restorations  : a ) ' Major ' failures ( signs and symptoms of irreversible pulpal disease ) : 19 Control restorations ( 15 % ) ; three Hall PMCs ( 2 % ) ( P < 0.000);b ) ' Minor ' failures ( loss of restoration , caries progression ) : 57 Control restorations ( 46 % ) ; six Hall PMCs ( 5 % ) ( P < 0.000)c ) Pain : 13 Control restorations ( 11 % ) ; two Hall PMCs ( 2 % ) ( P = 0.003 ) . Conclusion The Hall Technique was preferred to conventional restorations by the majority of children , carers and GDPs . After two years , Hall PMCs showed more favourable outcomes for pulpal health and restoration longevity than conventional restorations . The Hall Technique appears to offer an effective treatment option for carious primary molar teeth . Trial registration numberCurrent Controlled Trials IS RCT N47267892 – A r and omized controlled trial in primary care of a novel method of using preformed metal crowns to manage decay in primary molar teeth : the Hall technique Background In many parts of the world , school-age children have high dental treatment needs ; however , there is often low , or no , dental care provision . Although Atraumatic Restorative Treatment ( ART ) was developed to address this , its survival rate in occluso-proximal lesions is low . An alternative , the Hall Technique ( HT ) has shown better relative outcomes for occluso-proximal lesions , but has not been directly compared to ART or tested in field setting s. This trial will compare ART and the HT for the most clinical ly- and cost-effective strategy for managing occluso-proximal lesions in primary molars , in a school setting , using low-technology and child-friendly dental techniques . Methods / Design This two-arm , parallel group , patient-r and omized controlled , superiority trial will have treatment provided in schools . Schoolchildren ( n = 124 , age 6–8 ) with at least one occluso-proximal carious primary molar lesion will have r and om allocation to treatment with ART or HT . Baseline measures and outcome data will be assessed through participant report , clinical examination and parent report/ question naires . The primary outcome is survival rate , a composite measure of absence of Minor Failures ( a defect in the restoration/crown , but not interfering with tooth health ) and Major Failures ( signs or symptoms of irreversible pulp damage , such as dental fistula/abscess , tooth fracture or failures that can not be repaired ) . Secondary outcomes are : ( 1 ) child-reported discomfort , ( 2 ) childrens ’ and ( 3 ) parents ’ concerns around dental appearance and ( 4 ) acceptability of treatments , ( 5 ) occlusal-vertical dimensions ( OVD ) changes , ( 6 ) plaque index , ( 7 ) gingival health , ( 8) decayed , missing , filled teeth in permanent teeth (DMFT)/decayed , missing , filled teeth in primary teeth ( dmft ) , ( 9 ) oral health-related- quality of life , reported by children and parents/caregivers , ( 10 ) the incremental cost-effectiveness , and ( 11 ) operator effect . A trained and calibrated examiner will evaluate the treated teeth after 1 week , then 1 , 6 , 12 , 24 and 36 months post treatment . Kaplan-Meier and Cox regression tests will be used to investigate the primary outcome . The Mann-Whitney or t test , Friedman test , paired t test or Wilcoxon test and Ordinal Logistic Regression Analysis will be used to analyze the secondary outcomes . Discussion The results of this trial will support decision-making by clinicians and policy-makers for managing occluso-proximal lesions in setting s with constrained re sources and limited dental access . Trial registration www . clinical trials.gov , NCT02569047 , registered 5 October 2015 Atraumatic restorative treatment ( ART ) and minimal intervention treatment ( MIT ) techniques were evaluated under field conditions in 5 regions of the Western Cape Province of South Africa , where caries prevalence exceeds 60 % and remains mostly untreated . The purpose of the study was to compare and evaluate results of  ART and MIT techniques in the primary dentition of 6 - 9 year-old schoolchildren using  glass-ionomer ( GI ) ( Fuji IX ) and compomer ( Dyract AP ) material s. At baseline 401 children were treated , and 1,119 restorations  placed by 5 calibrated dentists , 53 % with ART ( using h and instruments only ) and 47 % with MIT ( minimal use of slow h and -piece ) techniques . Evaluations were done with a CPI periodontal probe to measure marginal defects and to detect decay . A pain assessment for the restoration procedures indicated that 80 % of subjects experienced no pain , 18 % discomfort and slight pain , and 2 % required local anaesthetic . After one year 90.5 % of subjects and 80 % of restorations were followed up ( 11.1 % lost as a result of exfoliation ) ; of these restorations 86 % were clinical ly acceptable ( 84.1 % of the ART and 88 % of the MIT ) . With the art technique 82.7 % of GI restorations and 85.6 % , of compomer restorations were acceptable . With the MIT technique 86.5 % of GI restorations and 89.9 % of compomer restorations were acceptable . Success of restorations per region varied significantly : regions 1 and 2 - 90 % , region 3 - 80 % , region 4 - 70 % and region 5 - 95 % . There were no significant statistical differences in respect of material s or methods employed . ART and MIT techniques were well accepted as complementary caries approaches by operators . One-year results show that ART and MIT techniques were successful , substantiating its use for the primary dentition in areas with high caries prevalence . Longer-term assessment s are required OBJECTIVE To compare the level of pain among children treated according to the Atraumatic Restorative Treatment ( ART ) and the Conventional Restorative Treatment ( CRT ) .  STUDY DESIGN Forty children of both genders , 4- to 7-years old , presenting Class I cavitated dentin lesions in primary molars were r and omly allocated to 2 groups . One group ( CRT ) received conventional restorative treatment using rotary instruments , while in the other one ( ART ) h and instruments were used to perform the restorations . All children were treated by the same operator A high-viscosity glass-ionomer cement ( Fuji IX ) was used to restore the teeth in both groups . Children 's pain was measured at the end of the first restorative treatment session using the Wong-Baker FACES Pain Rating Scale ( dependent variable ) . Age , gender , treatment time and treatment group were independent variables . ANOVA and ANCOVA tests were used to analyze the data . RESULTS The CRT procedure took longer than the ART procedure ( p < 0.001 ) . Children from the ART group reported less pain than those from the CRT group ( p = 0.0037 ) . Four year olds reported more pain than 5- to 7-year olds ( p < 0.0001 ) in both groups . CONCLUSIONS Restorations placed using ART were less time consuming , children felt less pain when the ART approach was used , and younger children ( 4-years ) reported more pain than the older ones for both restorative treatments BACKGROUND More conservative techniques for managing dental caries including ' partial ' and ' no caries removal ' have been increasingly of interest . AIM To compare children 's  behaviour and pain perception , also technique acceptability ( parents and dentists ) , when approximal dentinal lesions ( ICDAS 3 - 5 ) in primary molars ( 3 - 8-year-olds ) were managed with three treatment strategies ; conventional restorations ( CR ) , hall technique ( HT ) , and non-restorative caries treatment ( N RCT ) . DESIGN Secondary care-based , three-arm parallel-group , r and omised controlled trial , with 169 participants treated by 12 dentists . OUTCOME MEASURES child 's pain perception ( Visual Analogue Scale of Faces ) ; behaviour ( Frankl scale ) ; and parents ' and dentists ' treatment opinions ( 5-point Likert scales ) . RESULTS Children showed more negative behaviour in the CR group ( 37 % ) compared to N RCT ( 21 % ) and HT ( 13 % ) ( P = 0.047 , CI = 0.41 to 0.52 ) . Pain intensity was 
    Output:
    