The effect of postsurgical administration of a selective cyclo-oxygenase-2 inhibitor on the healing of intrabony defects following treatment with enamel matrix proteins.

Regenerative treatment with enamel matrix proteins (EMD) has been shown to promote regeneration in intrabony periodontal defects. However, up to now various postoperative regimens such as the routine administration of nonsteroidal anti-inflammatory drugs (NSAIDs) were often used in combination with enamel matrix proteins. Therefore, it cannot be excluded that the results might have been influenced by the effect of the postoperative medication. The aim of this randomized, controlled, blinded, clinical investigation was to determine the effect of postsurgical administration of a selective cyclo-oxygenase-2 inhibitor on the healing of intrabony periodontal defects following regenerative periodontal surgery with EMD. Twenty two patients, each of whom exhibited one deep intrabony defect, were randomly treated with either EMD plus a selective cyclo-oxygenase-2 (COX-2) inhibitor (test) or with EMD alone (control). The postoperative regimen consisted of oral administration of 12.5 mg rofecoxib twice daily for 14 days. The following parameters were recorded at baseline and at 6 months by the same calibrated and blinded investigator: plaque index (Pl), gingival index (GI), bleeding on probing (BOP), pocket depth (PD), gingival recession (GR), and clinical attachment level (CAL). Power analysis to determine superiority of the anti-inflammatory treatment showed that the available sample size would yield 70% power to detect a 1 mm difference. No statistical significant differences in any of the investigated parameters between the two groups were observed at baseline. The results show that, in the test group, mean PD decreased from 8.7+/-1.4 mm to 4.7+/-2.0 mm (P<0.001) and mean CAL from 9.7+/-2.0 mm to 6.5+/-2.1 mm (P<0.001). In the control group, mean PD decreased from 8.6+/-1.6 mm to 4.7+/-1.8 mm (P<0.001) and mean CAL from 9.5+/-1.6 mm to 6.5+/-2.2 mm (P<0.001). There were no significant differences between the two groups in any of the investigated parameters. Within the limits of the present study, it can be concluded that the systemic administration of a selective COX-2 inhibitor following regenerative periodontal surgery with EMD did not result in additional clinical improvements when compared to treatment with EMD alone.

RCT Entities:   Population Interventions Outcomes