Santamaria 2018.

Study characteristics
Methods	RCT, parallel group Duration of study: 2.5 years Setting: Department for Preventive and Paediatric Dentistry of Greifswald University, Germany
Participants	169 children Age: 3–8 years; mean 5.6, SD 1.5 years Caries experience: d3mft, 5.96 HT, 5.58 NRCC, 5.34 CR Inclusion criteria: children aged 3–8 years, a primary molar with an occluso‐proximal, surface caries lesion at the dentine level (ICDAS score 3–5), no clinical or radiographic signs or symptoms of pulpal or periradicular pathology, no systemic diseases that required special considerations for dental treatment and willingness to participate. Only 1 tooth per child was included in the study.
Interventions	3 treatment arms Group 1 (52 participants, 52 teeth): HT: no local anaesthesia, no caries removal, use of SSC cemented with luting cement. If the contact points were tight, orthodontic separator elastics were inserted and left in place for 2–3 days before placement of the crown at the next appointment. For HT, the participants underwent routine dental check‐ups twice per year. Group 2 (52 participants, 52 teeth): NRCT: the lesions were opened using a high‐speed bur removing the overhanging enamel to make the cavity accessible for plaque removal. The residual biofilm on the cavity was cleaned using a rotary bristle brush, and 22,600‐ppm fluoride varnish (Duraphat, GABA, Lörrach, Germany) was applied. Site‐specific toothbrushing instructions were given to parents/children using a bucco‐lingual technique and this was followed up with reinforcement of diet and oral hygiene instruction. For the NRCT arm, children were asked to attend every 3 months to monitor the lesion status and to reinforce dietary and oral hygiene advice to assist the caries arrest process, including Duraphat application on clinically active carious lesions. Group 3 (65 participants, 65 teeth): CR: non‐selective caries removal and compomer restorations. Local anaesthesia was used when needed. A high‐speed handpiece was used to gain access to the lesion; peripheral caries was removed with a slow handpiece and an excavator to cleave away the carious dentine from the pulpal wall. A matrix band and a porta‐matrix (Henry Schein Inc, Melville, NY, USA) or a T‐Band (Pulpdent, Watertown, MA, USA), and a wedge (Interdental Wedge, Kerr, Bioggio, Switzerland) were used to restore the cavities. All cavities were restored with Compomer (Dyract, Dentsply, Konstanz, Germany). For the CR arm, the participants underwent routine dental check‐ups twice per year.
Outcomes	Primary outcome Failures (minor and major) at 2.5 years; minor failure (reversible pulpitis, caries progression, or secondary caries), major failure (irreversible pulpitis, abscess, unrestorable tooth) Secondary outcome Survival at 2.5 years without any minor and major failure event Gingival and Plaque Index at 1 year, Plaque Index: 0 = no plaque, 1 = thin visible plaque, 2 = thick visible plaque. Gingival Index: 0 = no swelling, 1 = mild swelling, 2 = moderate‐to‐severe gingival swelling. Child's behaviour during the operative session was assessed by the dentists using the Frankl Behavior Rating Scale. This 4‐point scale ranges from definitely negative behaviour, when the child refuses the treatment, cry, etc. definitely positive behaviour, when the child is completely co‐operative. Pain: 5‐point scale includes 5 faces of children representing from very light to very intense pain. Children were asked to select the face that represents how he/she felt during treatment. Treatment perceptions and opinions: 5‐point Likert scales were used to assess parent's perceptions of their child's behaviour, comfort during treatment and satisfaction with treatment undertaken and dentist's ease of treatment provision/material, participant's discomfort and the relative time for the procedure. Parents were also asked whether they would choose the same treatment option again, and dentists were asked which treatment option, out with the study, they would have chosen for that tooth. Parent's perception of child behaviour and comfort
Notes	Schwendicke 2018 (see under Santamaria 2014) represents an analysis of Santamaria 2017, regarding cost‐effectiveness. Funding: Department for Preventive and Paediatric Dentistry of Greifswald University, Germany.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	A computer‐generated random number list with allocation concealment was used to assign children to 1 of 3 arms: HT, NRCT and CR.
Allocation concealment (selection bias)	Unclear risk	A computer‐generated random number list with allocation concealment was used to assign children to 1 of 3 arms: HT, NRCT and CR. Method not described in detail.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Personnel and participants could not be blinded as treatments were different.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not mentioned.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Reasons for attrition explained in CONSORT table; associated with moving away or failed to return. Dropout analyses showed no statistically significant differences between dropout cases and participants for mean age (P = 0.90), gender distribution (P = 0.49), d3mft values (P = 0.74), ICDAS score (P = 0.91), type of treated tooth (first or second primary molar, P = 0.32), or type of treatment (P = 0.93). In 5 cases (HT = 3; CR = 2), parents/children who did not attend recalls were reached by telephone.
Selective reporting (reporting bias)	Low risk	All data outcomes reported.
Other bias	Low risk	No other biases detected.

ART: atraumatic restorative treatment; CR: conventional restoration; DCE: dental continuing education; dmft: decayed, missed, filled teeth primary teeth; DMFT: decayed, missed, filled teeth permanent teeth; HT: Hall Technique; ICDAS: International Caries Detection and Assessment System; IPT: indirect pulp therapy; MCRL: minimal caries removal with only resin‐modified glass ionomer luting cement; MCRB/L: minimal caries removal with both resin‐modified glass ionomer base material and luting cement; NRCC: non‐restorative cavity control; NRCT: non‐restorative caries treatment; OHRQoL: Oral Health‐related Quality of Life; OVD: occlusal vertical dimension; PCR: partial caries removal; PDL: periodontal ligament; PMC: preformed metal crown; RCT: randomised controlled trial; RMGI: resin‐modified glass ionomer; RMGIC: resin‐modified glass ionomer cement; SD: standard deviation; SE: selective excavation; SEM: scanning electron microscope; SSC: stainless steel crown; SW: stepwise caries removal; USPHS: United States Public Health Service.