Xenografts With Platelet-rich Fibrin Versus Autogenous Bone in Alveolar Cleft Grafting

Not Applicable

• Conditions: Alveolar Cleft
• Interventions: Procedure: secondary alveolar bone graft; Procedure: Harvesting of the autogenous bone graft; Procedure: Preparation of PRP

• Registration Number: NCT04693741
• Lead Sponsor: Assiut University

Brief Summary

this work aims to evaluate xenografts mixed with PRF versus autogenous bone graft in alveolar cleft grafting.

Detailed Description

The alveolar cleft is a maxillary bone defect resulting from incomplete fusion of the medial nasal process (MNP) and maxillary process (MXP) during embryonic development. Alveoloplasty may be classified as primary, secondary, and tertiary depending on the age of the patient. Literature defines primary when the alveoloplasty is performed at the same time as soft tissue repair. If performed at the age of 8 to 9 years before the eruption of the permanent canine, it is classified as secondary; it is classified as late secondary or tertiary if performed in the elderly. For patients with cleft lip and palate, secondary alveolar bone grafting (SABG) of the cleft alveolar ridge is performed when the patient has mixed dentition; SABG is a procedure that aims to create a bony bridge that restores dental arch continuity, repair the oronasal fistula, provide support to the structure of the alar base, facilitate subsequent orthodontic treatment, and promote tooth eruption. Autologous bone grafting is the gold standard for treating alveolar clefts, with the iliac crest bone being the most widely accepted donor site. Other materials such as growth factors, combinations of improved scaffolds and cell treatment/growth factors, biocomposites, and hemostatic agents can be used to regenerate bone and have been the subjects of intensive research.

Study Timeline

• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-12-31
• Status Verified: 2021-01
• Study Start: 2021-01
• Last Update Submitted: 2021-01-03
• Study First Posted: 2021-01-05
• Last Update Posted: 2021-01-05
• Primary Completion: 2022-11
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Age (7 - 12 years).
• Non-syndromic CLA or CLP.
• More than 6 months of follow-up.

Exclusion Criteria

• History of previous alveolar surgery.
• History of active infection or underlying diseases such as hematologic disorders, neoplasm, and immune deficiency
• Patients who had received primary or tertiary ABG.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Autogenous iliac bone graft "group A"	Harvesting of the autogenous bone graft	The autogenous iliac bone graft will be used to fill the alveolar defect.
Xenograft with PRF "group B"	Preparation of PRP	Xenograft with PRF will be used to fill the alveolar defect.
Autogenous iliac bone graft "group A"	secondary alveolar bone graft	The autogenous iliac bone graft will be used to fill the alveolar defect.
Xenograft with PRF "group B"	secondary alveolar bone graft	Xenograft with PRF will be used to fill the alveolar defect.

Primary Outcome Measures

Name	Time	Method
measuring of bone volume 6 months post-operative.	6 months	Compare between outcome of xenografts mixed with PRF versus autogenous bone graft in alveolar cleft grafting regarding the newly formed bone volume.