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

Evaluation of Anterior Alveolar Ridge Reconstruction With Allogenic Bone Plate and Autogenous Cortical Bone Chips: A Radiographic and Histological Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: Alveolar Bone Resorption
• Intervention / Treatment: Procedure: Horizontal alveolar bone augmentation

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11566
    • Faculty of Dentistry Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alveolar Bone quantity	Alveolar bone width by millimeters using Cone Beam Computed Tomography	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alveolar Bone quality	Histological evaluation of status of regenerated bone vitality and remodeling	7 months

Collaborators and Investigators

• Sponsor: October 6 University
• Collaborators: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2018
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): September 5, 2019

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (Actual): March 27, 2020

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 6, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Allograft; Autogenous chips; Horizontal augmentation; Khoury shell technique
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Bone Resorption
• Other Study ID Numbers: OMS-2018-03M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No