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Completed

NCT Number: NCT04324697

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

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.

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Key information

Conditions

Alveolar Bone Resorption

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Dentistry Ain Shams University

Cairo, 11566, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Horizontal alveolar bone augmentation

Procedure

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

Other names: MAXGRAFT@Cortico - Botiss

Primary outcomes

  1. Alveolar Bone quantity

    Time frame: 6 months

    Alveolar bone width by millimeters using Cone Beam Computed Tomography

Secondary outcomes

  1. Alveolar Bone quality

    Time frame: 7 months

    Histological evaluation of status of regenerated bone vitality and remodeling

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Collaborators

  • Ain Shams University

Registry information

Official study title

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

Acronym: Shell grafting

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 27, 2020
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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