Co-crystal of Tramadol-Celecoxib in Patients with Moderate to Severe Acute Post-surgical Oral Pain: A Dose-Finding, Randomised, Double-Blind, Placebo- and Active-Controlled, Multicentre, Phase II Trial.

Background: Co-crystal of tramadol-celecoxib (CTC), containing equimolar quantities of the active pharmaceutical ingredients (APIs) tramadol and celecoxib (100 mg CTC = 44 mg rac-tramadol hydrochloride and 56 mg celecoxib), is a novel API-API co-crystal for the treatment of pain. We aimed to establish the effective dose of CTC for treating acute pain following oral surgery.

Methods: A dose-finding, double-blind, randomised, placebo- and active-controlled, multicentre (nine Spanish hospitals), phase II study (EudraCT number: 2011-002778-21) was performed in male and female patients aged ≥ 18 years experiencing moderate to severe pain following extraction of two or more impacted third molars requiring bone removal.

Internal distraction osteogenesis with a unidirectional device for reconstruction of mandibular segmental defects.

Purpose: To present the authors' clinical experience with unidirectional internal distraction devices to reconstruct mandibular defects.

Patients And Methods: Five patients have been treated with mandibular distraction osteogenesis to reconstruct different acquired segmental defects. These mandibular defects (35 to 80 mm in length) were reconstructed by means of internal distraction devices with a transcutaneous activator.