title: Caries management strategies for primary molars: 1-yr randomized control trial results.
abstract: Minimal invasive approaches to managing caries, such as partial caries removal techniques, are showing increasing evidence of improved outcomes over the conventional complete caries removal. There is also increasing interest in techniques where no caries is removed. We present the 1-yr results of clinical efficacy for 3 caries management options for occlusoproximal cavitated lesions in primary molars: conventional restorations (CR; complete caries removal and compomer restoration), Hall technique (HT; no caries removal, sealing in with stainless steel crowns), and nonrestorative caries treatment (NRCT; no caries removal, opening up the cavity, teaching brushing and fluoride application). In sum, 169 children (3-8 yr old; mean, 5.56 ± 1.45 yr) were enrolled in this secondary care-based, 3-arm, parallel-group, randomized clinical trial. Treatments were carried out by specialist pediatric dentists or postgraduate trainees. One lesion per child received CR, HT, or NRCT. Outcome measures were clinical failure rates, grouped as minor failure (restoration loss/need for replacement, reversible pulpitis, caries progression, etc.) and major failure (irreversible pulpitis, abscess, etc.). There were 148 children (87.6%) with a minimum follow-up of 11 mo (mean, 12.23 ± 0.98 mo). Twenty teeth were recorded as having at least 1 minor failure: NRCT, n = 8 (5%); CR, n = 11 (7%); HT, n = 1 (1%) (p = .002, 95% CI = 0.001 to 0.003). Only the comparison between NRCT and CR showed no significant difference (p = .79, 95% CI = 0.78 to 0.80). Nine (6%) experienced at least 1 major failure: NRCT, n = 4 (2%); CR, n = 5 (3%); HT, n = 0 (0%) (p = .002, 95% CI = 0.001 to 0.003). Individual comparison of NRCT and CR showed no statistically significant difference in major failures (p = .75, 95% CI = 0.73 to 0.76). Success and failure rates were not significantly affected by pediatric dentists' level of experience (p = .13, 95% CI = 0.12 to 0.14). The HT was significantly more successful clinically than NRCT and CR after 1 yr, while pairwise analyses showed comparable results for treatment success between NRCT and CR (ClinicalTrials.gov NCT01797458).
authors.affiliation: Department of Preventive and Paediatric Dentistry, Ernst-Moritz-Arndt University of Greifswald, Greifswald, Germany ruth.santamaria@uni-greifswald.de.
authors.forename: R M
authors.initials: RM
authors.lastname: Santamaria
authors.affiliation: The Division of Oral Health Science, School of Dentistry, University of Dundee, Dundee, Scotland, UK.
authors.forename: N P T
authors.initials: NP
authors.lastname: Innes
authors.affiliation: Clinic of Dental and Oral Pathology, Faculty of Odontology, Lithuanian University of Health Sciences, Kaunas, Lithuania.
authors.forename: V
authors.initials: V
authors.lastname: Machiulskiene
authors.affiliation: The Division of Oral Health Science, School of Dentistry, University of Dundee, Dundee, Scotland, UK.
authors.forename: D J P
authors.initials: DJ
authors.lastname: Evans
authors.affiliation: Department of Preventive and Paediatric Dentistry, Ernst-Moritz-Arndt University of Greifswald, Greifswald, Germany.
authors.forename: C H
authors.initials: CH
authors.lastname: Splieth
mesh_terms: D002327:Cariostatic Agents / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D003442:Crowns; D003731:Dental Caries / Q000517:prevention & control*; D003737:Dental Cavity Preparation / Q000379:methods; D003774:Dental Plaque Index; D019232:Dental Restoration Failure; D003793:Dental Restoration, Permanent / Q000379:methods; D018450:Disease Progression; D005460:Fluorides, Topical / Q000627:therapeutic use; D005500:Follow-Up Studies; D006801:Humans; D008963:Molar / Q000473:pathology*; D009910:Oral Hygiene / Q000193:education; D010508:Periodontal Abscess / Q000209:etiology; D010512:Periodontal Index; D011671:Pulpitis / Q000209:etiology; D019233:Retreatment; D014094:Tooth, Deciduous / Q000473:pathology*; D014099:Toothbrushing / Q000379:methods; D016896:Treatment Outcome
chemical_list: D002327:Cariostatic Agents; D005460:Fluorides, Topical
keywords: The Hall Technique; caries treatment; clinical outcomes; clinical studies/trials; pediatric dentistry; primary teeth