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

Assiut University

Status: Unknown

Conditions: Alveolar Cleft

Treatments: Procedure: Preparation of PRP; Procedure: secondary alveolar bone graft; Procedure: Harvesting of the autogenous bone graft

Study type: Interventional

Funder types: Other

Identifiers

NCT04693741

alveolar bone graft

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 7 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Autogenous iliac bone graft "group A"

Other group

Description:

The autogenous iliac bone graft will be used to fill the alveolar defect.

Treatment:

Procedure: secondary alveolar bone graft

Procedure: Harvesting of the autogenous bone graft

Xenograft with PRF "group B"

Other group

Description:

Xenograft with PRF will be used to fill the alveolar defect.

Treatment:

Procedure: secondary alveolar bone graft

Procedure: Preparation of PRP