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 occasions 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 clinical antiinflammatory effect, was given 4 times daily for 3 days starting 2 h after surgery in one trial using 20 patients (mean age 22.7 years, 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). Identical 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 bilateral operations. Pain intensity difference scores as measures of analgesia suggested the influence of carryover effects with respect to the second operation, irrespective of drug starting time. Mouth opening ability was not similar on each occasion after bilateral surgery. It can be concluded that the carryover design in bilateral surgery is valid and useful with respect to testing drug effects on swelling. The bilateral third molar model also offers the ability to test clinically relevant multiple dose regimens in phase 3 trials. It should, however, be recognized that the bilateral third molar model is highly dependent on the skill of the surgeon and may thus be more difficult to complete than parallel group trials.
Björnsson
G A
GA
Department of Oral Surgery and Oral Medicine, University of Oslo, Norway.
Bjørnland
T
T
Skoglund
L A
LA
D000328:Adult; D002983:Clinical Competence / Q000592:standards; D003061:Codeine / Q000008:administration & dosage / Q000627:therapeutic use*; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D008297:Male; D008964:Molar, Third / Q000601:surgery*; D010149:Postoperative Pain / Q000188:drug therapy*; D011183:Postoperative Complications / Q000188:drug therapy*; D015203:Reproducibility of Results; D014081:Tooth Extraction / Q000592:standards*; D044465:White People
D003061:Codeine