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Completed

NCT Number: NCT06304376

Evaluation of Shell Technique in Secondary Alveolar Cleft Grafting

This study aims to evaluate the sufficiency of Khoury shell technique for reconstruction of alveolar cleft. Khoury technique was carried out using cortical bone shell fixed away from alveolar bone using two micro-screws, which was harvested from anterior iliac bone crest. The gap between the shell cortical bone and the native alveolar bone was filled by cancellous bone which was harvested from anterior iliac crest bone. The whole graft was covered by collagen membrane. The volumetric bone gain of the defect was determined via CBCT.

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Key information

Conditions

Alveolar Cleft Alveolar Ridge Cleft

Age range

7 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ministry of Health, Farwaniya Hospital

Al Farwaniyah, 81004, Kuwait

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with alveolar ridge cleft
  • Males and females 7-14 years of age.
  • Patients with adequate oral hygiene.
  • Compliance with all requirements in the study and signing the informed consent.

Exclusion criteria

  • Patients with diseases of the immune system or any medical condition that may influence the outcome (uncontrolled diabetes, Glycated hemoglobin- HbA1c ≥ 7%).
  • Patients with systemic disease affecting bone healing.
  • Patients who are chronic users of medications known to affect the periodontal status (calcium antagonists, anti-convulsives, immunosuppressives, anti-inflammatory medications).
  • Patients with history of intravenous and/or oral bisphosphonate use.
  • Pathologic lesions or acute infection in the area of defect.
  • Patients with poor oral hygiene that are not amenable to motivation and improvement.
  • Vulnerable patients.

Treatment and study plan

Alveolar ridge grafting

Procedure

Alveolar ridge grafting was carried out using anterior iliac crest bone graft. Khoury shell technique was the method of ridge reconstruction via a cortical bone shell was fixed away from alveolar ridge using two micro-screws and the gap created was filled by cancellous bone

Primary outcomes

  1. Volumetric bone gain

    Time frame: 4 months

    bone volumetric gain and changes measured by CBCT analysis

Secondary outcomes

  1. Eruption of the tooth in the cleft

    Time frame: 6-9 months

    Eruption of the tooth assessed clinically and radiographically

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Collaborators

  • Ministry of Health, Kuwait

Registry information

Official study title

Evaluation of Shell Technique for Reconstruction of Alveolar Cleft: Retrospective Study

Acronym: Alveolar cleft

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 12, 2024
Registry last updated
Mar 12, 2024

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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