Radiographic and Histological Evaluation of Regenerated Bone After Grafting Using Allograft Shell and Autogenous Chips

NCT ID: NCT04324697

Last Updated: 2020-06-09

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

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-08

Study Completion Date

2019-09-05

Brief Summary

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The clinical cases in the present study described the khoury shell technique using an allograft plate and autogenous chips, for horizontal reconstruction of the anterior alveolar ridge in the esthetic zone. Without need to use autogenous bone graft techniques that are characterized by more aggressive surgery.

Detailed Description

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Conditions

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Alveolar Bone Resorption

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Reconstruction of the localized deficient anterior maxilla using an allograft cortical bone plate, which was fixed at a distance from the alveolar ridge using two micro-screws, and the created gap between the allograft plate and the alveolar ridge was filled with autogenous cortical bone chips harvested intraorally using a bone scrapper.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Horizontal alveolar bone augmentation

Horizontal augmentation in anterior maxilla using allograft shell and autogenous chips with no need for a second surgical site

Intervention Type PROCEDURE

Other Intervention Names

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MAXGRAFT@Cortico - Botiss

Eligibility Criteria

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Inclusion Criteria

* Patients with class IV of Cawood and Howell classification in the anterior maxilla.
* Males and females 18-50 years of age.
* Patients with adequate oral hygiene.
* Patients with healed sites for at least 6 months after tooth extraction.
* Patients with an inter-arch distance of at least 6 mm.
* Compliance with all requirements in the study and signing the informed consent.

Exclusion Criteria

* Patients with diseases of the immune system or systemic disease affecting bone healing
* Patients who are chronic users of medications known to affect the periodontal status.
* Patients with history of intravenous and/or oral bisphosphonate use.
* Pathologic lesions or acute infection in the area of defect.
* Patients who are pregnant or lactating mothers.
* Heavy smokers who smoke more than 10 cigarettes a day.
* Patients with poor oral hygiene that are not amenable to motivation and improvement.
* Patients with history of irradiation of the head and neck region.
* Vulnerable patients.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role collaborator

October 6 University

OTHER

Sponsor Role lead

Responsible Party

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Khalid Tarek Mohamed Karkar

Teaching assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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OMS-2018-03M

Identifier Type: -

Identifier Source: org_study_id

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