Western Society of Periodontics

Clinical Studies

Volume Number 4, 1995

A comparison of topical ketoralac, systemic flurbiprofen, and placebo for the inhibition of bone loss in adult periodontitis

This human study compared the progression of alveolar bone loss in a test group of periodontitis patients receiving 1% ketoralac rinse, systemic flurbiprofen, and a negative control. The investigators took 55 patients with untreated periodontitis, each of whom had three posterior teeth in two quadrants with 30-50% radiographic bone loss and pocket depths of 5-8 mm which bled on probing. They also utilized the low-dose dental bone scan to see if these sites were undergoing bone loss at the time of the study. They monitored PI, GI, PD, and attachment levels at baseline, three and six months. The patients were randomized into three groups: (1) placebo rinse and placebo tablet two times daily, (2) placebo rinse and 50 mg systemic flurbiprofen two times daily, and (3) 0.1% ketoralac rinse and placebo tablet two times daily. Change in alveolar bone height was measured using digital subtraction radiography. The researchers also looked at changes in bone mass, PD, PAL, PI, GI, and PGE2 and IL-1B concentrations. The patients remained on their medications for six months. The patient compliance was encouraged by giving them 30-second timers, and the medication vials were fitted with a monitoring system to record the date and time the vial was opened. The radiographs were assessed in a blind fashion.

The results showed that the mean compliance was not statistically different among the groups. Patients treated with ketoralac rinse showed an average increase of 0.21 mm at three months; patients in the flurbiprofen group showed no bone loss during the six-month study; and the placebo group lost 0.38 mm of bone in the first three months and a total of 0.63 mm by six months. Bone height was preserved significantly more with ketoralac compared to placebo (0.83 mm) and the flurbiprofen compared to placebo (0.53 mm). So ketoralac preserved more alveolar bone height than flurbiprofen (0.30 mm). Bone mass from three to six months showed that the placebo group lost a mean of 5.84 mg at three months and 16.21 at six months. The ketoralac group showed an increase up to 3.17 mg at three months and 3.67 mg at six months. The flurbiprofen group showed no change at three months but lost 6.44 mg at six months. The ketoralac rinse preserved 10.11 mg more alveolar bone mass than flurbiprofen. Over the six-month period the ketoralac group gained 0.16 mm, the flurbiprofen gained 0.47 mm, and the placebo gained 0.57 mm. There was no significant difference in probing depth change and gingival index. The placebo and ketoralac group demonstrated significant reductions in plaque index. Patients in the ketoralac rinse demonstrated a significant decrease in PGE2 from baseline to three and six months, while the placebo group had an increase in PGE2. There was no association between decrease in crevicular PGE2 and decrease in alveolar bone loss. The mean level of ketoralac in plasma was 45 ng/ml. This is in contrast to the plasma level of 0.7 to 1.1 g/ml following a 10 mg oral dose. The authors conclude that the ketoralac rinse may be beneficial in treating adult periodontitis. [M.C.R.]