Skip to main content
OpenTrials
Completed

NCT Number: NCT04205591

Comparative Study Between Porcine and Autologous Cortical Plates

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bone Regeneration

Age range

18 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Split Bone Block Technique

Procedure

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

Primary outcomes

  1. Volume of bone augmentation

    Time frame: 4 months

    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

Secondary outcomes

  1. Postoperative pain

    Time frame: 4 months

    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.

  2. Bone box time consuming

    Time frame: Minutes

    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.

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2019
First posted
Dec 19, 2019
Registry last updated
Dec 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.