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Comparative Study Between Porcine and Autologous Cortical Plates

U

Universidad Complutense de Madrid

Status

Completed

Conditions

Bone Regeneration

Treatments

Procedure: split bone block technique

Study type

Interventional

Funder types

Other

Identifiers

NCT04205591
P-15/567

Details and patient eligibility

About

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.

Full 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

Enrollment

16 patients

Sex

All

Ages

18 to 68 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

16 participants in 2 patient groups

Autologous cortical plate
Active Comparator group
Description:
Thin autologous cortical plates that allow to made a rigid and resistant framework that will be filled with autogenous bone chips bone
Treatment:
Procedure: split bone block technique
Porcine cortical plate
Experimental group
Description:
Thin porcine cortical platesthat allow to made a rigid and resistant framework that will be filled with autogenous bone chips bone
Treatment:
Procedure: split bone block technique

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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