Evaluation of Shell Technique in Secondary Alveolar Cleft Grafting (Alveolar cleft)

March 8, 2024 updated by: Khalid Tarek Mohamed Karkar, October 6 University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kuwait
      • Al Farwānīyah, Kuwait, 81004
        • Ministry of Health, Farwaniya Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

8. Vulnerable patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: study group
This study group contains of patient who had alveolar cleft, indicated for late secondary alveolar grafting
Procedure: Alveolar ridge grafting
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volumetric bone gain
Time Frame: 4 months
bone volumetric gain and changes measured by CBCT analysis
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eruption of the tooth in the cleft
Time Frame: 6-9 months
Eruption of the tooth assessed clinically and radiographically
6-9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

October 6 University

Collaborators

Ministry of Health, Kuwait

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2022

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

February 22, 2024

Study Registration Dates

First Submitted

March 1, 2024

First Submitted That Met QC Criteria

March 8, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OMFS/FSDC002

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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