Use of animal derived bone substitutes in oral reahabilitation

Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2021
INTERVENTION: A01.941.875 E04.545.550.100 E06.584 Horizontal ridge augentation with deproteinized bovine bone blocks, comapred to autologous block from mandibular ramus, in aplit‐mouth study design. 12 health patients, aging from 18‐75 years‐old receive the standard treatment (control) at one side of maxyllary ridge, and experimetnal treatment (bovine bone block)at the other side. Grafts were ramdomly allocated to each site. CONDITION: Alveolar ridge atrophy K00‐K93 PRIMARY OUTCOME: Another primary outcome was the clinical complications after graft placement, this complications were assessed by qualitative classfication, in each post operative appointments. The researches evalauted: wound dehiscence, paresthesia, wound infection, swelling, haemathoma, and seroma formation thoughout visual evaluation and inquiring.; The main outcome was the incorporation of the graft to the donor site. These outcome was assessed by computed tomography, in three different periods: pre‐operative, immediately after graft placement, and 9 motnhs after healing. Clinical measurements of thickness and volume were also performed, as well as bone biopsies of grafted areas, to evaluate the microarchitectural pattern and histolgoical incorporation of graft. The bone volume was expressed in mm³; the micro architechture was assessed by bone volume ratio, trabecular number, thickness and separation, also connectivity and trabecular pattern. The histological incorporation was assessed by percentage of mineralized tissue and percentage of remnant biomaterial. SECONDARY OUTCOME: Another secondary outcome was the implant stability quocient, the stability was assessed by frequncimenter Ostell, measured in a standard scale betwenn 0 and 100, being 100 the most stable condition. Secondary outcome was the realibility of implant placement in grafted areas. This reliability was assessed thorghout implant instalation torque. The implant torque was measured by a digital torquimeter attached to the counter angle head, and measuren in Newtons, . INCLUSION CRITERIA: adult (over 18 years old); any sex; with totally edentulous maxillary ridge; remaining alveolar bone width between 2 and 10mm; remaining alveolar height of at least 10mm.
Epistemonikos ID: 76370db5861178c9ddd96e9c49ccd0f69fdaa9d3
First added on: Aug 24, 2024