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

NCT04324697 | Completed Phase 4

• 1 other identifier: OMS-2018-03M
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alveolar Bone Resorption

Keywords

Allograft; Autogenous chips; Horizontal augmentation; Khoury shell technique

Outcome Measures

Primary Outcomes (1)

• Alveolar Bone quantity

  Alveolar bone width by millimeters using Cone Beam Computed Tomography

  6 months

Secondary Outcomes (1)

• Alveolar Bone quality

  7 months

Interventions

Horizontal alveolar bone augmentation PROCEDURE

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

Also known as: MAXGRAFT@Cortico - Botiss

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• October 6 University: lead
• Ain Shams University: collaborator

Study Sites (1)

Faculty of Dentistry Ain Shams University

Cairo, 11566, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant

Model Details: 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.

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 27, 2020
• Study Start: April 8, 2018
• Primary Completion: July 1, 2019
• Study Completion: September 5, 2019
• Last Updated: June 9, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)