Ultrasound to stimulate early bone formation in a distraction gap: a double blind randomised clinical pilot trial in the edentulous mandible

Objective: In a double blind randomised clinical pilot trial, it was investigated whether tow intensity pulsed ultrasound therapy stimulates early bone formation in a distraction gap created in a severely resorbed mandible. Design: Eight patients underwent a mandibular vertical distraction over an average distance of 6.6 +/- 1.1 mm. Ultrasound self-therapy or placebo therapy was started on the first day of distraction and continued daily until the implants were inserted. After 31 +/- 3.8 days of consolidation, the distraction device was removed, a transmandibular biopsy was taken, and two endosseous implants were inserted. Results: All patients complied well with ultrasound therapy. During an average of 30.1 +/- 4.1 months follow-up, no complications did occur. Microradiographic examination of the biopsies revealed a comparable mean area of mineralised tissue in the distraction gap of 1.9 +/- 1.7 mm(2) in the ultrasound treatment group and 1.9 +/- 1.3 mm(2) in the placebo treatment group. Histological examination indicated that active woven bone was present within the distraction gap just adjacent to the osteotomy plane, with no apparent differences between the treatment groups. The Lamellar bone formation outside the distraction gap appeared to have started as well. Conclusion: During a 31-day consolidation period, ultrasound treatment does not appear to stimulate bone formation in the severely resorbed vertical distracted mandible and it seems that this period is too short to evaluate property if there is an effect. Therefore, a longer consolidation period has to be studied. (c) 2004 Elsevier Ltd. All rights reserved.