Evaluation of Bilateral Alveolar Cleft Grafting With Micro Plate Stabilization Versus Conventional Grafting Technique

July 23, 2024 updated by: Maha Ahmed Ibrahim Ahmed, Cairo University

Clinical and Radiographic Evaluation of Bilateral Alveolar Cleft Grafting With Micro Plate Stabilization Versus Conventional Grafting Technique: A Preliminary Clinical Trial

The aim of the study is to enhance the maxillary segments stability during graft healing using microplate fixation to be compared with conventional grafting technique regarding gained bone quality and quantity.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In conventional cleft grafting technique, there is always risk for grafted bone resorption and recurrence of fistula formation. So alveolar cleft grafting using anterior iliac crest bone particles combined with microplate fixation of maxillary segments will work more efficient and prevent the fore mentioned risk of graft resorption and recurrence of fistula.

In conventional cleft grafting techniques, most of the cases reported in literature raised a debate regarding the final gained amount of bone, with subsequent recurrence of oronasal fistula. In this study, alveolar cleft grafting using anterior iliac crest bone particles combined with microplate fixation of maxillary segments and the conventional grafting technique will be compared to evaluate which technique will offer better reconstruction of the alveolar ridge with maintained bone width and height.

Study Type

Interventional

Enrollment (Estimated)

12

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 Contact

Study Contact Backup

Study Locations

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:

  • Patients with bilateral complete maxillary alveolar cleft at the age of mixed dentition (between 9 and 12 years old).
  • repaired cleft lip.
  • Patients with medical history that did not hinder surgical intervention and have adequate proper oral hygiene.
  • Both genders males and females will be included.

Exclusion Criteria:

  • General contraindications to surgical intervention of the area.
  • Patients with unilateral maxillary alveolar cleft.
  • Patients with ill repaired cleft lip that will hinder the appropriate reconstruction of the alveolar cleft
  • Subjected to irradiation in the head and neck area less than 1 year before surgery.
  • Untreated periodontitis.
  • Poor oral hygiene.
  • Uncontrolled diabetes.
  • Immunosuppressed or immunocompromised.
  • Active infection or severe inflammation in the area intended for graft placement
  • Unable to open mouth sufficiently to accommodate the surgical tooling.
  • Patients participating in other studies, if the present protocol could not be properly followed.
  • Unable to attend a 9-month follow-up.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bilateral alveolar cleft grafting using iliac crest particulate and microplate fixation

in bilateral alveolar cleft, the cancellous particulate bone graft from anterior iliac crest will be used to fill the defect, 8-hole microplates will be used to fix the premaxilla using screws.

The microplates are to be removed 6 to 9 months postoperatively.
Procedure: bilateral alveolar cleft grafting using iliac crest particulate and microplate fixation
bilateral alveolar cleft grafting using particulate iliac crest graft accompanied with fixation of graft and premaxilla using microplate
Active Comparator: bilateral alveolar cleft grafting using iliac crest particulate
in bilateral alveolar cleft, the cancellous particulate bone graft from anterior iliac crest will be used to fill the defect.
Procedure: bilateral alveolar cleft grafting using iliac crest particulate and microplate fixation
bilateral alveolar cleft grafting using particulate iliac crest graft accompanied with fixation of graft and premaxilla using microplate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone density immediate versus 6 months postoperatively.
Time Frame: 6 months
bone density changes are measured using CBCT after 6 months via HU
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone width and height immediate versus 6 months postoperatively
Time Frame: 6 months
bone height and width changes are measured using CBCT after 6 months in mm
6 months

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Director: Sameh Mekhemer, PhD, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

July 24, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

July 23, 2024

First Submitted That Met QC Criteria

July 23, 2024

First Posted (Actual)

July 26, 2024

Study Record Updates

Last Update Posted (Actual)

July 26, 2024

Last Update Submitted That Met QC Criteria

July 23, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 4623358

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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