Whitworth · International endodontic journal 2005 · randomized controlled trial · n=602 teeth

Endodontic complications after plastic restorations in general practice.

Cited 70 times in the scientific literature.

Level 2 - randomized trial

Individual randomized controlled trial.

PubMed 15910477 · doi:10.1111/j.1365-2591.2005.00962.x · record verified 2026-08-28

What was done

Healthy adults requiring new or replacement posterior restorations across six general practices were recruited. A total of 602 cavity preparations were randomized to receive either a calcium hydroxide lining (n = 288, 47.8%) or conditioning-and-sealing with a smear-removing bonding system (n = 314, 52.2%). Choice of bulk restorative material (composite resin vs amalgam) was left to the dentist's discretion. Pulpal status was evaluated at unscheduled emergency visits and scheduled recalls at 6, 12, 24, and 36 months. Postoperative sensitivity was tracked on a 100 mm visual analogue scale at 24 hours, 4 days, and 7 days. Logistic regression was used to identify factors associated with pulpal breakdown.

What was found

Across 36 months, 16 cases of pulp breakdown were identified (11 emergency presentations, 5 routine recall detections). Pulp breakdown showed no association with lining vs conditioning-and-sealing, preoperative pain, or rubber dam use. Pulp breakdown was significantly associated with deep or pulpally exposed cavities (OR 7.8, P < 0.001) and composite resin compared to amalgam (OR 2.13, P = 0.001). Re-coding identified pulpal exposure as the main determinant of failure (OR 28.4, P < 0.0001), with composite remaining at higher risk than amalgam (OR 3.92, P = 0.017). Follow-up attendance was 64.8% (390 teeth) at 6 months, 51.0% (307 teeth) at 12 months, 60.3% (363 teeth) at 24 months, and 46.3% (279 teeth) at 36 months.

Why it matters

In routine general dental practice, adhesive conditioning-and-sealing provides pulpal protection equivalent to traditional calcium hydroxide liners up to 3 years. It reinforces that residual dentine thickness and avoiding pulpal exposure are the primary determinants of post-restorative pulp vitality.

Limits

Follow-up attrition was high, with fewer than half of the teeth (46.3%) evaluated at 36 months. Bulk restorative material selection was not randomized, introducing potential confounding by indication for composite vs amalgam outcomes. The overall number of pulp breakdown events was low (16 events), which limits statistical precision.

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