Abstract
To test the hypothesis that dentine and pulp protection by conditioning-and-sealing is no less effective than using a conventional calcium hydroxide lining. A cohort of healthy adults requiring a new or replacement restoration in a posterior tooth was recruited in six general practices. All procedures received local Ethics Committee approval. Exclusion criteria included signs and symptoms of pulp necrosis or inflammation, and patients unable to commit to a long-term trial. Cavity preparations were randomized to receive a calcium hydroxide lining or conditioning-and-sealing with a smear-removing bonding system. Choice of bulk restorative material (composite resin or amalgam) was at the discretion of the dentist. The key outcome measure was evidence of pulpal breakdown identified at unscheduled (emergency) or scheduled recall examinations. Postoperative sensitivity was recorded on 100 mm VAS at 24 h, 4 days and 7 days. Pulp status was assessed at 6, 12, 24 and 36 month recall, and at any emergency recall appointment. The relationship between pre-treatment and treatment variables and pulp breakdown was assessed by logistic regression (P = 0.05). A total of 602 teeth were recruited, with comparable numbers of cavities lined (288, 47.8%) or conditioned and sealed (314, 52.2%). The majority (492, 81.7%) were replacement restorations, and amalgam was the most common bulk restorative material (377, 62.6%). A total of 390 (64.8%) restored teeth were reviewed at 6 months, 307 (51%) at 12 months, 363 (60.3%) at 24 months, and 279 (46.3%) at 36 months post-restoration. Sixteen cases of pulp breakdown were identified within 36 months of restoration placement, 11 presenting as emergencies and five detected at routine recall examination. Logistic regression showed that preoperative pain, cavity treatment by lining or conditioning-and-sealing and the use of rubber dam isolation had no association with pulp breakdown. Pulp breakdown was associated with deep or pulpally exposed cavities (P < 0.001, odds ratio 7.8) and with composite rather than amalgam restorations (P = 0.001, odds ratio 2.13). Re-coding to identify teeth with pulp exposures revealed that pulpal exposure was the key determinant of adverse pulp outcomes (P < 0.0001, odds ratio 28.4) and that composite resin restorations were again more likely to be associated with pulp breakdown than amalgam (P = 0.017, odds ratio 3.92). Considered within the context of routine primary dental care: Dentists can be confident that pulps will be equally well protected from post-restorative breakdown up to 36 months by calcium hydroxide lining and conditioning-and-sealing with adhesive resins. Residual dentine thickness appears to be a key determinant of pulp responses after restorative dental treatment. In deep and pulpally exposed cavities in posterior teeth, composites were associated with more pulpal breakdown than amalgams.
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