Memarpour 2016.

Methods	Trial design: parallel (3 arms) Location: Shiraz, Iran Number of centres: 5 Duration: recruitment began in December 2012 and was completed within 4 months. Follow‐up appointments were scheduled at 4 months, 8 months, and 12 months after the initial dental appointment for each child
Participants	Participants: 300 children participants Inclusion criteria: "The main inclusion criterion was age between 12 and 24 months at the beginning of the study. All children had resided since birth in Shiraz, where water fluoridation levels are similar (< 0.07 ppm) in all areas. All participants had at least 4 erupted primary teeth. None of the teeth showed signs of non‐cavitated or cavitated caries (dmft = 0). The parents did not use any oral hygiene methods such as toothbrushing or any fluoride products at home or in other clinics. All parents were interviewed to explain the aim of the study, and all parents provided their informed consent in writing. A schedule of appointments was provided and parents were asked to attend the healthcare center to receive both free health and dental care service during the study period" Exclusion criteria: "The exclusion criteria were medical history of systemic diseases, drug allergies, congenital physical or mental disabilities, oral or dental anomalies or disabilities, and unwillingness to participate due to lack of time" Age at baseline (months): mean age intervention Group A: 20.70 ± 7.04; intervention Group B: 21.04 ± 8.86; control: 19.73 ± 8.24 Gender: intervention Group A: 48 (48%) female and 52 (52%) male; intervention Group B: 47 (47%) female and 53 (53%) male; control group: 42 (42%) female and 58 (58%) male Number randomised: 300 (intervention Group A: 100; intervention Group B: 100; control Group: 100) Number evaluated: ‐ month 4 follow‐up: total 288 (intervention Group A: 97, intervention Group B: 95, control group: 96) ‐ month 8 follow‐up: total 281 (intervention Group A: 94, intervention Group B: 93, control group: 94) ‐ month 12 follow‐up: total 260 (intervention Group A: 85, intervention Group B: 87, control group: 88)
Interventions	Intervention Group A: at the first appointment, parents in group 2 completed the questionnaires and received a free gift bag that contained an educational pamphlet and a toothbrush. The pamphlet explained the importance of caring for primary teeth, the factors that influence Severe Early Childhood Caries (SECC), instructions on how to prevent SECC with a non‐cariogenic diet and feeding methods, and instructions for oral hygiene. Parents received face‐to‐face oral health instructions that were included in the pamphlet and were trained in the proper use of a toothbrush (Kagihara 2009). Children in this group received a placebo fluoride varnish as previously described. Subsequent appointments were scheduled until the end of the follow‐up period, and the placebo varnish was applied at baseline and at the 6‐month follow‐up appointment Intervention Group B: the parents received oral health instruction as described for group 2. The dentist cleaned the children's teeth by brushing and isolated them with cotton rolls. Fluoride varnish that contained 5% sodium fluoride (DuraShield, Sultan Healthcare, Hackensack, NJ, USA) was applied with a disposable brush to all tooth surfaces and left for 1 minute. A small amount of varnish was applied to all primary teeth at baseline. The parents were advised not to allow the child to eat rough (abrasive) foods for the remainder of the day (Holve 2008) and not to brush until the following day (Weyant 2013). The fluoride varnish was applied again 6 months later. This group is not further included in this review Control: mothers completed the questionnaires, and the children's teeth were examined at baseline. Control group participants did not receive any oral healthcare intervention. The placebo, a water‐based coloured solution similar to fluoride varnish, was painted over the tooth surfaces. The solution was tasteless and odourless. The baseline procedure for placebo application was repeated at the follow‐up appointment 6 months later Prophylaxis provided: no baseline prophylaxis Member of dental team delivering intervention: dentist Frequency of intervention: each group attended for 2 'intervention' appointments and 3 review appointments. Each child received a new toothbrush every 3 months Intensity of intervention (length of time): all procedures including completion of the questionnaires, oral hygiene instruction and performing the intervention took about 30 minutes to 40 minutes for each child in all groups Setting: public health care centres Disease level: none of the teeth showed signs of non‐cavitated or cavitated caries (dmft = 0)
Outcomes	Clinical outcomes: "The primary outcome was the influences of the interventions on the incidence of caries. The children's teeth were examined by 2 trained dentists with the arm‐cradling or knee‐to‐knee positions. First the dentists were given instructions by a senior author (MM) with a role‐playing technique on how to perform the oral examination, interview the mothers, provide oral health instructions, and complete the questionnaire. To ensure consistency, under supervision by the senior author, both examiners assessed 15 children as part of the training for this research (pilot study) during 1 week. The examiners used disposable dental mirrors, a head light and ball‐ended World Health Organization CPI probes according to their criteria for the diagnosis of dental caries (WHO 1997). Initially the teeth were cleaned with a toothbrush, then wiped with a cotton roll and allowed to air dry. We used the dmft index to record the presence of any caries. This index is defined by 'd' indicating a decayed tooth, 'm' indicating a missing tooth due to decay, and 'f' indicating a filled tooth. Both dentists were present at the follow‐up appointments. The Kappa values for caries detection showed a high level of agreement between the 2 examiners at all 3 follow‐up time points (range 0.940–1). In case of disagreement during the evaluations, consensus evaluations were obtained between the examiners. The data were collected and recorded at each follow‐up period" Knowledge and performance outcomes: "Parents' knowledge and performance regarding oral health was assessed as the secondary outcome. The questionnaire addressed (1) demographic information of the child, i.e. age, gender, place of birth, general health status, and dental history; (2) parents' information, including level of education, employment, family income, and mother's age; (3) parents' knowledge, evaluated as their knowledge about factors that contribute to SECC, the role of brushing and fluoride in caries prevention, bottle feeding of milk or sweet liquids, and the importance of caring for primary teeth, and (4) parents' performance on activities to ensure the child's oral health, including brushing the child's teeth, frequency of brushing, frequency of snacking, method of milk feeding, sharing utensils with the child during meals and checking the child's teeth"
Notes	Funding: "Vice‐Chancellery of Research of Shiraz University of Medical Sciences, Shiraz, Iran. Grant No 92‐6158" Sample size calculation: "A sample size of 60 persons per group was estimated to be sufficient to detect a clinically significant difference of 20% between groups in caries incidence using a 2‐tailed test of proportions between 2 groups with 80% power and a 5% level of significance. This difference represents a 30% incidence of caries in the control group [Kumarihamy 2011; Mohebbi 2006;Mohebbi 2008] and a 10% incidence of caries in the fluoride varnish group 12 months after the start of the study. However, because of the long study period, a sample size of 300 children (100 in each group) was finally selected at baseline to compensate for the high rate of probable withdrawal (> 50%)" Adverse effects: not reported Declarations/conflicts of interest: quote: "There are no conflicts of interest"
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "A staff member randomly assigned 100 children from the list of children with dmft = 0 to each group using a block randomization method (total n = 300), with a block length of B = 6. Random allocation sequences were generated by a statistician with a random number table and were concealed from the 2 examiners until the start of the study" Comment: adequate random sequence generation
Allocation concealment (selection bias)	Unclear risk	Quote: "..and were concealed from the 2 examiners until the start of the study" Comment: insufficient information regarding allocation concealment
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "Parents were blinded to the study groups. They were not aware which group their child had been randomized to regarding the use of fluoride varnish or a placebo" Comment: the dentists were likely to know the patients allocation. Blinding of participants was not possible; it is unclear the influence this would have on the risk of bias for this domain
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "Parents were blinded to the study groups. They were not aware which group their child had been randomized to regarding the use of fluoride varnish or a placebo" Comment: the parents and children (aged 12 months to 14 months) would be unlikely to know what group they were allocated to. The dentists may have known the patients allocation when clinically assessing participants teeth and parent's performance so unclear if this may have affected outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: all participants accounted for, explanation of dropouts provided
Selective reporting (reporting bias)	Low risk	All outcomes in methods section were reported
Other bias	Low risk	No apparent other bias