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Search / Trial NCT06523855

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

Launched by CAIRO UNIVERSITY · Jul 23, 2024

Trial Information

Current as of August 23, 2025

Not yet recruiting

Keywords

Alveolar Cleft Iliac Crest Grafting Microplate Bone Resorption Oronasal Fistula

ClinConnect Summary

This clinical trial is looking at two different methods for treating patients with bilateral alveolar clefts, which are gaps in the upper jaw that can affect speech and eating. The study aims to see if using a new technique called microplate stabilization can improve the healing and strength of the bone graft, compared to a more traditional method. By comparing these two approaches, researchers hope to find the best way to support healing in young patients.

To be eligible for this trial, children aged 9 to 12 who have had a cleft lip repaired and have a complete bilateral alveolar cleft may participate. However, there are some important criteria that could exclude potential participants, such as having other medical conditions that make surgery risky, poor oral hygiene, or active infections. Those who join the study can expect to undergo a surgical procedure with follow-up visits for up to nine months to monitor their recovery and the success of the grafting technique. This trial is not yet recruiting, but it's an important step towards improving treatment for children with this condition.

Gender

ALL

Eligibility criteria

  • 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.

About Cairo University

Cairo University, a premier institution in Egypt, is dedicated to advancing medical research and education through innovative clinical trials. With a strong emphasis on improving healthcare outcomes, the university collaborates with various stakeholders to conduct rigorous scientific studies that address critical health challenges. Leveraging its extensive resources and expert faculty, Cairo University aims to contribute valuable insights to the medical community and enhance patient care both locally and globally. Through its commitment to ethical research practices and excellence, the university plays a pivotal role in shaping the future of healthcare in the region.

Locations

Cairo, , Egypt

Patients applied

0 patients applied

Trial Officials

Sameh Mekhemer, PhD

Study Director

Cairo University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported