REPRODUCIBILITY OF POSTOPERATIVE COURSES AFTER SURGICAL REMOVAL OF SYMMETRICALLY IMPACTED WISDOM TEETH

The acute postoperative courses after bilateral ''identical'' surgical removals of symmetrically impacted third molars on two separate occas ions were investigated in a study containing two separate trials. Both trials were conducted as open interpatient crossover trials. Codeine phosphate (50 mg), with assumed analgesic effect but with no known cli nical antiinflammatory effect, was given 4 times daily for 3 days star ting 2 h after surgery in one trial using 20 patients (mean age 22.7 y ears, 12 females/8 males) and starting 3 h after surgery in the other trial using 20 patients (mean age 23.0 years, 11 females/9 males). Ide ntical surgical procedures were carried out by the same surgeon in the same patient. The study shows the mean postoperative time courses of pain intensity sum pain intensity and swelling to be similar after bil ateral operations. Pain intensity difference scores as measures of ana lgesia suggested the influence of carryover effects with respect to th e second operation, irrespective of drug starting time. Mouth opening ability was not similar on each occasion after bilateral surgery. it c an be concluded that the crossover design in bilateral surgery is vali d and useful with respect to testing drug effects on swelling. The bil ateral third molar model also offers the ability to test clinically re levant multiple dose regimens in phase 3 trials. It should, however be recognized that the bilateral third molar model is highly dependent o f the skill of the surgeon and may thus be more difficult to complete than parallel group trials.