Comparative Study Between Porcine and Autologous Cortical Plates

NCT04205591 | Completed

• 1 other identifier: P-15/567
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Bone Regeneration

Keywords

split bone block; RCT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Postoperative pain

  4 months

• Bone box time consuming

  Minutes

Study Arms (2)

Autologous cortical plate

ACTIVE COMPARATOR

Thin autologous cortical plates that allow to made a rigid and resistant framework that will be filled with autogenous bone chips bone

Procedure: split bone block technique

Porcine cortical plate

EXPERIMENTAL

Thin porcine cortical platesthat allow to made a rigid and resistant framework that will be filled with autogenous bone chips bone

Procedure: split bone block technique

Interventions

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

Autologous cortical plate; Porcine cortical plate

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Officials

• Jesus Torres, Associate

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Bone augmentation procedures using autogenous cortical plates or xenograft cortical plates were carried on, both using autogenous bone chips to fill the resulting gap. Patients included in this clinical trial were randomly allocated by a blinded assistant in two groups: Autogenous Cortical Plates (ACP) and Xenograft Cortical Plates (XCP). Random allocation of participants to intervention groups was performed using a computerized random number generated by the GraphPad- QuickCalc software (GraphPad Soft- ware Inc., La Jolla, CA) As a result, 9 patients were randomly assigned to de ACP group and 9 to the XCP group. All surgeries were performed by the same oral surgeon (JT).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 16 patients referred for implant placement and with insufficient bucco-lingual (BL) alveolar bone width (\<4 mm) were included in the study.. Patients included in the clinical trial were randomly allocated by a blinded assistant in two groups: in the autogenous cortical plate group (ACP), and xenogeneic cortical plate group (XCP).

Study Record Dates

• First Submitted: December 15, 2019
• First Posted: December 19, 2019
• Study Start: May 10, 2013
• Primary Completion: September 8, 2017
• Study Completion: September 13, 2019
• Last Updated: December 19, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share