Ga. Bjornsson et al., REPRODUCIBILITY OF POSTOPERATIVE COURSES AFTER SURGICAL REMOVAL OF SYMMETRICALLY IMPACTED WISDOM TEETH, Methods and findings in experimental and clinical pharmacology, 17(5), 1995, pp. 345-356
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.