***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: Investigators should properly calculate sample sizes before the start of their r and omised trials and adequately describe the details in their published report . In these a-priori calculations , determining the effect size to detect -- eg , event rates in treatment and control groups -- reflects inherently subjective clinical judgments . Furthermore , these judgments greatly affect sample size calculations . We question the br and ing of trials as unethical on the basis of an imprecise sample size calculation process . So-called underpowered trials might be acceptable if investigators use method ological rigor to eliminate bias , properly report to avoid misinterpretation , and always publish results to avert publication bias . Some shift of emphasis from a fixation on sample size to a focus on method ological quality would yield more trials with less bias . Unbiased trials with imprecise results trump no results at all . Clinicians and patients deserve guidance now OBJECTIVE Motivational interviewing ( MI ) is an effective intervention for improving health behavior in a number of domains , and evidence suggests that it may be useful for promoting oral health . The current pilot study was design ed to provide initial evidence that , compared with a didactic control intervention , a brief MI-based intervention ( BMI ) delivered by dental practitioners can yield greater improvements in oral hygiene , health-care utilization , and health outcomes in a population at heightened risk for oral disease . METHOD Either the control intervention or BMI , delivered by a dentist or a dental hygienist , was r and omly assigned to 60 individuals in inpatient treatment for alcohol-use disorders . Data were obtained by self-report and by examination at baseline and 4- , 12- , and 24-week follow-up assessment s. RESULTS BMI participants reported significantly more frequent toothbrushing during follow-up than control participants . No other significant effects were found . CONCLUSION These findings indicate that a brief intervention using MI methods can be delivered by dental professionals and has potential utility for promoting improved oral hygiene . Additional research to investigate and further develop MI 's potential for promoting oral health appears warranted Objectives To clarify and illustrate sample size calculations for the cross-sectional stepped wedge cluster r and omized trial ( SW-CRT ) and to present a simple approach for comparing the efficiencies of competing design s within a unified framework . Study Design and Setting We summarize design effects for the SW-CRT , the parallel cluster r and omized trial ( CRT ) , and the parallel cluster r and omized trial with before and after observations ( CRT-BA ) , assuming cross-sectional sample s are selected over time . We present new formulas that enable trialists to determine the required cluster size for a given number of clusters . We illustrate by example how to implement the presented design effects and give practical guidance on the design of stepped wedge studies . Results For a fixed total cluster size , the choice of study design that provides the greatest power depends on the intracluster correlation coefficient ( ICC ) and the cluster size . When the ICC is small , the CRT tends to be more efficient ; when the ICC is large , the SW-CRT tends to be more efficient and can serve as an alternative design when the CRT is an infeasible design . Conclusion Our unified approach allows trialists to easily compare the efficiencies of three competing design s to inform the decision about the most efficient design in a given scenario Background Globally , dental caries is categorized in the list of public health problems in preschool children . In India , lack of availability and affordability of oral health enhances the cost of treatment and care . Empowering community workers like anganwadi workers ( AWWs ) in oral health , and providing basic oral health awareness to the mothers through them can be feasible model . So , the present study was conducted to evaluate the short-term impact of Oral Hygiene Training Package ( OHTP ) to AWWs on improving oral hygiene of preschool children . Methods This before and after comparison field trial was done in Anganwadi centres ( AWCs ) of Ch and igarh city , India . 534 children aged 36 - 72 months attending 21 AWCs were examined before and after imparting trainings to AWWs . OHTP was administered to AWWs , which consisted of power-point presentation and demonstrated the skills like proper brushing technique , plaque disclosure , flossing technique , gum massaging etc . The AWWs later imparted training to mothers in their respective AWCs . Post intervention data was collected after three months . Outcome measures were improvement in oral health status ( plaque , debris , gingival health ) , oral habits ( brushing , rinsing ) and decrease in caries activity ( Snyder test ) . Results Prevalence of dental caries was found to be 48.3 % . Only 4.1 % of the population reported brushing twice which increased significantly to 9.9 % post-intervention ( p = 0.000 ) . There was a significant decrease in debris ( 78.3 % to 54.1 % ) , and stage-1 plaque ( 75.5 to 66.5 % ) in the oral cavity . Caries activity by Snyder ’s test decreased from 48.2 % to 31.2 % ( p = 0.01 ) post-intervention . Conclusions Controlled trials of using AWWs to improve oral hygiene appear to be justified . Trial registration OBJECTIVE To assess the effect of oral health education on knowledge and oral health seeking behaviour of persons living with HIV/AIDS ( PLWHA ) . METHODS Quasi-experimental study design conducted among 195 Persons living with HIV/AIDS attending two Comprehensive Care Centres ( CCC ) at the Kenyatta National Hospital ( intervention group ) and Mbagathi district hospital ( non-intervention group ) in Nairobi Kenya . The participants were selected using systematic r and om sampling method and data collected using a question naire . Data was collected at baseline , at three months ( review 1 ) and at six months ( review 2 ) . RESULTS There was a significant change in oral health knowledge for KNH participants . However , no significant change in oral knowledge was recorded for MDH participants . The proportion of participants who brushed their teeth at least twice a day increased significantly from 52 % to 88 % for KNH . The proportion of those who had brushed the previous evening increased from 47 % to 83.2 % . There was no significant change in the proportion brushing at least twice a day among the non-intervention group . There was a significant association between change in knowledge and change to brushing at least twice a day among the intervention group . CONCLUSION Oral health education led to improved oral health knowledge and oral hygiene practice s among PLWHA OBJECTIVE This paper reports the results of a community trial to measure the clinical impact of a linked series of interventions on  Early Childhood Caries ( ECC )  and general caries levels among five-year-old children . It exemplifies the problems of undertaking population based interventions in deprived communities . RESEARCH DESIGN Two health districts ( Primary Care Groups ) were matched for dental disease levels and socio-demographic factors . One was r and omly allocated to be the active intervention PCG , the other the comparison PCG .  Children in the active PCG  received a series of interventions to support positive dental health behaviour  from the age of 8 to 32 months . Clinical examinations were undertaken on a cohort of 5-year-old children in both active and comparison PCGs . SETTING In the active PCG , children who attended design ated clinics for their 8-month developmental checks and /or MMR inoculations at 12 to 15 months , were given gift bags , the first contained a trainer cup , the second fluoride toothpaste ( 1450 ppm F ) and toothbrush . Parents were also given written , pictorial and verbal advice on oral care . Further supplies of toothpaste and brushes were posted to the children 's homes at 20 , 26 and 32 months . When five years of age children in the two PCGs were examined in school . OUTCOME MEASURES Severity and prevalence of ECC and general caries . Levels of participation . RESULTS Among participants in the active PCG the prevalence of ECC , general caries and extraction experience and mean dmft ( 20 % : 54 % : 3 % : 2.2 ) were lower than in ' participants ' in the comparison area ( 32 % : 64 % : 12 % : 3.7 ) . All differences were statistically significant . When all children ( participants and non- participants ) in the two PCGs were compared , the differences were much reduced ( 30 % : 63 % : 6 % : 3.1 vs. 32 % : 64 % : 12 % : 3.6 ) . A higher proportion of children in the active PCG area ( 47 % ) were found not to have participated in the interventions , when compared to 21 % in the comparison area . Disease levels in the non- participants in the active PCG were particularly high . The impact of participation bias , changes in baseline balance , population mobility and alternative study design on outcomes are explored . CONCLUSION The impact of non-participation in a deprived , urban conurbation with high levels of population mobility are sufficient to dilute the impact of a health intervention such that few benefits are discernible at a population level OBJECTIVE To examine the effectiveness of exp and ing and improving oral health education in a clinical setting . RESEARCH DESIGN Controlled prospect i ve intervention study . INTERVENTION Structured comprehensive oral health education ( SC-OHE ) supported by written information . was performed by 36 clinicians in all of the 30 specialist paediatric practice s in the city and the administrative district of Kassel , central Germany . PARTICIPANTS Parents of all children attending the practice s for health examinations .  SC-OHE was tested in two intervention groups ( IG ) , one with a mean child age of seven months and another with a mean child age of 24 months . The SC-OHE content was adapted to the respective age groups . Control group ( CG ) subjects were recruited in a similar region in northern Germany and received conventional oral health education only . This consisted of comparable topics but was less comprehensive than SC-OHE .  The two IGs comprised 2,170 children ; the two age-matched CGs 2,040 . OUTCOME MEASURES Parental knowledge , attitudes and behaviour relevant to decreasing the risk of early childhood caries ( ECC ) development . The outcomes were measured by question naires sent to the parents . RESULTS The response rate was 88 % . On average , control group paediatricians provided 2.1 information items at each child examination whereas the intervention group provided 3.8 items . Parental knowledge increased by 23 % . Self-efficacy and attitudes remained unchanged . 41 % of 7-month-olds in the CG received baby bottles with  cariogenic content during daytime as opposed to 32 % in the IG ( p < 0.001 ) ; however , bottle use at night was unchanged . IG parents were less likely to add sugar to puréed baby food of the 7-month-olds . In 24-month-old children , the frequent consumption of cariogenic beverages in the daytime decreased slightly ( CG 66 % , IG 61 % , p < 0.001 ) , but five other nutritional behaviours , fluoride use and tooth brushing remained unchanged . CONCLUSIONS Primary care providers can be trained to perform SC-OHE that improves parental oral health knowledge .  SC-OHE provided by clinicians alone will not be capable of influencing crucial oral health behaviours in such a way that prevents ECC OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity OBJECTIVE This paper reports the results of a community trial to assess the effects of a multi-stage dental health promotion programme in reducing  Early Childhood Caries ( ECC ) .  RESEARCH DESIGN Two health districts ( Primary Care Groups ) were matched for dental disease levels and socio-demographic factors . One was r and omly allocated to be the test Primary Care Group 
    Output:
    
CONCLUSIONS Most studies evaluating behavioral and periodontal outcomes have shown significant improvements in favor of interventions .
Educational interventions carried out by health professionals in the context of their practice have the potential to promote oral health in the population