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Comparative Study Between Porcine and Autologous Cortical Plates

NCT ID: NCT04205591

Last Updated: 2019-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-10

Study Completion Date

2019-09-13

Brief Summary

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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.

Detailed Description

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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

Conditions

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Bone Regeneration

Keywords

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split bone block RCT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
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).

Study Groups

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Autologous cortical plate

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

Group Type ACTIVE_COMPARATOR

split bone block technique

Intervention Type 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

Porcine cortical plate

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

Group Type EXPERIMENTAL

split bone block technique

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Jesús Torres García Denche

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jesus Torres, Associate

Role: PRINCIPAL_INVESTIGATOR

Universidad Complutense de Madrid

Other Identifiers

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P-15/567

Identifier Type: -

Identifier Source: org_study_id