Comparative Study Between Porcine and Autologous Cortical Plates

Bone Regeneration Clinical Trial

Official title:

Split Bone Block Technique: Clinical and Radiographic Study Between Autologous and Porcine Xenogeneic Cortical Plates. Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04205591
• Other study ID #: P-15/567
• Status: Completed
• Phase: N/A
• Start date: May 10, 2013
• Est. completion date: September 13, 2019

Study information

• Verified date: December 2019
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the outcome of three-dimensional bone regeneration procedures using thin cortical porcine xenograft plates in combination with autogenous bone chips compared with thin autogenous cortical plates and autogenous bone chips.

Description:

Materials and methods: 16 patients referred for implant placement and with insufficient bucco-lingual (BL) alveolar bone width (<4 mm) were included in the study. Patients received autogenous cortical plates (ACP) of either porcine xenogeneic (XCP). The aforementioned groups were compared in regards to bone augmentation using General Estimating Equations (GEE) and logistic regression. Demographic data, trabecular bone density, graft site, postoperative pain, and time consuming were also analyzed

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 13, 2019
• Est. primary completion date: September 8, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 68 Years

Eligibility

Inclusion Criteria:

• Patients were enrolled in the study on the basis of having insufficient bone height (<6mm), width (<3mm) or both, in either maxilla or mandible

Exclusion Criteria:

Patients with severe systemic disease (American Society of Anesthesiology III or IV) were excluded from the study.

In addition, patients who were pregnant, or patients with diseases affecting bone, such as:Paget's disease, osteomalacia, diabetes, vitamin D deficiency, alcoholism, hyperthyroidism cancer or osteoporosis as well as those on medications that might affect bone metabolism, such as bisphosphonates, corticosteroids or antiepileptic medicaments were also excluded from the study.

Related Conditions & MeSH terms

• Bone Regeneration

Intervention

Procedure:
• split bone block technique
A graft surgery using autogenous bone chips surrounded by a rigid framework made over the atrophic sites of the mandible and maxilla to obtain bone augmentation to support dental implants

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume of bone augmentation	Volume of bone augmentation of the surgical sites was measured in the postoperative parasagittal CT scans using a region of interest (ROI) containing the entire bone box regenerated area using the closed polygon tool of the OsiriX software. This measurements have been done in mm3	4 months
Secondary	Postoperative pain	The amount of pain was classified into three categories: heavy pain, with the patient taking more than eight painkillers (ibuprofen 400); moderate pain, when the patient took four to eight painkillers; or little pain, when the patient needed fewer than four painkillers.	4 months
Secondary	Bone box time consuming	In the control group this was measured from the moment the osteotomy incision began with the MicroSaw until the bone block was completely removed, splitting cortical plates and fixation to the buccal and lingual/palatal side of the bone defect using osteosynthesis screws after it is filled with the bone chips harvested previously. In experimental group the time was measured from the open of porcine cortical plate envelope until the bone box was completely filled and sealed.	Minutes