Clinical, volumetric and densitometric evaluation of tissue engineered constructs for secondary alveolar cleft reconstruction: A randomized clinical trial

The objective of this study was to assess the efficacy of tissue engineered (TE) constructs compared to the standard autogenous anterior iliac crest (AIC) bone graft in secondary maxillary alveolar cleft reconstruction. This clinical trial was registered on (clinical trials.gov); the trial registry number is: NCT03563495. Patients with unilateral alveolar clefts were allocated on the basis of simple randomization. Selected patients were randomly divided into two equal groups: the AIC group (control) received autogenous particulate bone graft from anterior iliac crest, whereas the TE group received tissue engineered construct. Assessment included the newly formed bone volume and density at the grafted cleft sites, which were measured immediately, 6 and 12 months postoperatively on axial computed tomograms. The study population included 10 patients; each group comprised 5 patients. There was no statistically significant difference between the 2 groups regarding the mean volume of the newly formed bone (p = 0.91 at 6 months, p = 0.994 at 1 year) and the mean density of the newly formed bone (p = 0.364 at 6 months, p = 0.073 at 1 year). However, there was a significant increase of TE graft density from 6 months to 1 year (p = 0.048). Within the limitations of the study it seems that the tissue engineered construct (collagen/osteogenically differentiated bone marrow−derived mesenchymal stem cells) might be an alternative to autogenous bone for unilateral secondary alveolar cleftgrafting.