Subjects: From 2001 to 2004, 17 general dental practitioners (GDPs) in Tayside, Scotland, recruited 132 children aged 3 to 10 years at enrollment who had caries affecting matched pairs of asymptomatic primary molar teeth for participation in this split-mouth randomized controlled trial. Of these 264 study teeth with caries lesions, 42% were radiographically more than halfway into dentin, and 67% required Class II restorations. In 2000, the regional decayed/missing/filled teeth (DMFT) number was 2.47 (d3 1.71; mt 0.54; ft 0.22). Ninety-one patients (69%) had 48 months minimum of follow-up, or both teeth had reached an end point (ie, extracted, exfoliated, censored) before this time.
Key Exposure/Study Factor: One molar tooth in the study pair was allocated to the Hall technique (HT) (intervention), and the contralateral tooth was allocated to the practitioner’s usual treatment (control). Practitioners accessed computer-generated randomization for treatment allocation and order by telephoning a central administrator. According to the HT protocol, food could be removed from the cavity, but there was to be no other cavity preparation. The correct size of crown was selected, and the crown and tooth were washed and dried. The crown was filled with glass-ionomer cement (GIC) and seated with digital pressure before the child was instructed to bite down hard to seat the crown fully. Excess GIC was removed, and the child was instructed to continue biting down until the cement had set.
Main Outcome Measure: Major failures were indicated by the signs and symptoms of irreversible pulpitis or dental abscess (requiring pulp therapy or extraction), interradicular radiolucency, restoration loss and unrestorable tooth, and internal root resorption.
Main Results: At 60 months, for 91 patients with at least 48 months of follow-up, major failures (ie, irreversible pulpitis, loss of vitality, abscess, or unrestorable tooth) were recorded for 18 teeth: 3 (3%) for HT (treatment arm) and 15 (16.5%) for the usual treatment (control) (P = .000488; number-needed-to-treat [NNT] = 8).
Conclusion: The authors concluded that sealing in caries by using the HT was more effective statistically and clinically, in the long term, and significantly outperformed the GDPs’ standard restorations.