Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06523855

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

9 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

bilateral alveolar cleft grafting using iliac crest particulate and microplate fixation

Procedure

bilateral alveolar cleft grafting using particulate iliac crest graft accompanied with fixation of graft and premaxilla using microplate

Primary outcomes

  1. Bone density immediate versus 6 months postoperatively.

    Time frame: 6 months

    bone density changes are measured using CBCT after 6 months via HU

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Alaa Hassan, MSc

CONTACT

[email protected]

01090101125 ext. +2

Maha Ibrahim, bachelor of dentistry

CONTACT

[email protected]

01116003653 ext. +2

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 26, 2024
Registry last updated
Jul 26, 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.

Published trials that share one or more normalized conditions with this study.