Zanata 2003.

Methods	Randomised controlled trial
Participants	81 pregnant women and their fetuses were randomised. Inclusion criteria: pregnant women (in the second or third trimester), without any medical recommendations that could make dental treatment inadvisable, and presenting three or more active carious lesions (cavities) in smooth dental surfaces (proximal, buccal or lingual) Exclusion criteria: not reported Setting: nine Basic Health Units in the suburbs of Bauru, Brazil (recruitment and study dates not reported) Important health characteristics reported: all included women had three or more active carious lesions (cavities) in smooth dental surfaces (proximal, buccal or lingual).
Interventions	Group 1 (n = 43 women randomised) Women received primary care intervention and topical application of antimicrobial agents at baseline. The primary care intervention comprised elimination of infection sites through tooth extraction,endodontic dressings, root scaling and sealing of cavities with glass ionomer cement Fuji IX (GC Dental Co., Japan). The topical application of NaF and iodine solution was carried out in 3 sessions: the first immediately after prophylaxis, and the second and third applications after 3 and 5 days, respectively, without prophylaxis, after dental care of the patient, as suggested by Caufield 1979. The composition of this solution was 1.0 g KI, 1.2 g NaF, 53.0 mL glycerin, H2O to complete 100 mL, solution adjusted to pH 4.5 using 85% H3PO4 according to the recommendations of Dasanayake 1993. At six months follow‐up, the antimicrobial solution and topical fluoride were reapplied in the experimental group mothers. At 12 months follow‐up: prophylaxis, fluoride therapy and decontamination with iodine solution treatment and all new cavities were excavated and sealed and defective restorations were repaired. Group 2 (n = 38 women randomised) At baseline/enrolment, cavities in posterior teeth were filled with the zinc oxide‐eugenol cement IRM (Dentsply Ltd., Petropolis, RJ, Brazil), whereas the anterior teeth were restored with the composite Fill Magic (Vigodent, Rio de Janeiro, RJ, Brazil). The first intention was to restore all cavities with zinc oxideeugenol cement, which is the intermediate restorative material used by public health services in Bauru. However, because of immediate failure of this material in a number of class III, IV and V preparations and its unpleasant appearance that led to rejection by the patients, the composite was used. At 6 and 12 months, clinical intervention received by women in this group included treatment for emergency procedures only. Timing: initial intervention during second or third trimester of pregnancy, with follow‐up interventions at 6 and 12 months (> 6 months intervention duration) Theory or model used as a basis for intervention: the composition of the antimicrobial agent applied to the teeth of women was based on the recommendations of Dasanayake 1993. All participants: received oral health education, targeted at mother and child, at baseline and follow‐up (six and 12 months)
Outcomes	Data in meta‐analysis for:primary outcome: caries presence in primary teeth; secondary outcomes: mother DMFS increment Tabulated data for: none Additional narrative text for: none Additional outcomes that had not been prespecified: Child: none reported. Mother: none reported
Notes	Funding: Quote: "We thank FAPESP (Fundação de Amparo à Pesquisa do Estado de São Paulo) for the technical, scientific and financial support that were fundamental for the accomplishment of this study". Declarations of interest: unclear; not reported in English
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "these subjects were randomly divided into two groups, experimental and control".
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not reported; unlikely considering intervention and comparator assessed
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "clinical assessments (not blind)"
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	High loss to follow‐up, with 30/38 (78%) of the women randomised to the control group and 34/43 (79%) of the women randomised to the experimental group completing the study; however marginal difference in attrition rates across groups
Selective reporting (reporting bias)	Unclear risk	No access to study protocol and therefore could not confidently assess this domain as at high or low risk of bias
Other bias	Unclear risk	Insufficient information to assess confidently, e.g. lack of adequate data comparing group participants on key characteristics

^{AI: American Indian; AIDS: aquired immune deficiency syndrome; AN: Alaskan native; BFHI: baby friendly hospital initiative; BMI: body mass index; CFU: colony‐forming unit; CHX: chlorhexidine; defs: decayed, extracted and filled surfaces; dmfs: decayed, missing and filled services in primary teeth; dmft: decayed, missing and filled primary teeth; DVD: digital versatile disk; EBF: exclusively breastfed; ECC: early childhood caries; FAPESP: Fundação de Amparo à Pesquisa do Estado de São Paulo; FDA: Food and Drug Administration; H2O: dihydrogen monoxide (water); H3PO4: phosphoric acid; HDL: high density lipoprotein; HS: Indigenous Health Service; IRM: intermediate restorative material; KI: potassium Iodine; KJ: kilojules; MI: motivational interviewing; MIC: maternal and infant care; MS: mutans streptococci; NaF: sodium fluoride; pH: power of hydrogen; P/M/S: polyunsaturated / monounstaturated / saturated fatty acids; RCT: randomised controlled trial; SAFA: saturated fatty acid; STRIP: Special Turku Coronary Risk Factor Intervention Project for Babies; UNICEF: United Natiions International Children's Emergency Fund; USP: United States Pharmacopeia; w/v: weight / volume; w/w: weight/weight; WHO: World Health Organization}