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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-12
SponsorCairo University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • bilateral alveolar cleft grafting using iliac crest particulate and microplate fixation

    Procedure/Surgery

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

Treatment groups

12 Participants
are divided into 2 treatment groups
Group A: bilateral alveolar cleft grafting using iliac crest particulate and microplate fixationExperimental treatment 1 intervention
Group B: bilateral alveolar cleft grafting using iliac crest particulateActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Bone density immediate versus 6 months postoperatively.

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

Time frame
6 months

Secondary outcomes

1

Bone width and height immediate versus 6 months postoperatively

bone height and width changes are measured using CBCT after 6 months in mm

Time frame
6 months

Other outcomes

Sponsors and contacts

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