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

Alveolar Bone Resorption Clinical Trial

— Shell grafting  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04324697
• Other study ID #: OMS-2018-03M
• Status: Completed
• Phase: Phase 4
• Start date: April 8, 2018
• Est. completion date: September 5, 2019

Study information

• Verified date: April 2020
• Source: October 6 University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 5, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Bone Resorption
• Bone Resorption

Intervention

Procedure:
• Horizontal alveolar bone augmentation
Horizontal augmentation in anterior maxilla using allograft shell and autogenous chips with no need for a second surgical site

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry Ain Shams University	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
October 6 University	Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alveolar Bone quantity	Alveolar bone width by millimeters using Cone Beam Computed Tomography	6 months
Secondary	Alveolar Bone quality	Histological evaluation of status of regenerated bone vitality and remodeling	7 months