Assessment of Nanocrystalline Hydroxyapatite Versus Autogenous Bone Grafts : A Comparative Clinical Study in Alveolar Cleft Grafting

Assiut University

Status: Unknown

Conditions: Alveolar Cleft

Treatments: Procedure: secondary alveolar bone graft; Procedure: harvesting of the autogenous bone graft; Procedure: Nanocrystalline Hydroxyapatite

Study type: Interventional

Funder types: Other

Identifiers

NCT04693559

AssiutU011270

Details and patient eligibility

About

This work aims to evaluate Nanocrystalline Hydroxyapatite versus Autogenous bone grafts in alveolar cleft grafting

Full description

Alveolar cleft is the most common congenital bone defect. Since its introduction in 1972, alveolar bone grafting (ABG) has been widely accepted to correct alveolar bone defect in most cleft centres.The purpose of ABG is to restore the dental arch continuity, stabilize the maxilla, close the oronasal fistulae, facilitate subsequent orthodontic treatment, enhance nasal symmetry, establish better oral hygiene, limit growth disturbances, etc . Autologous bone grafting is the gold standard for treating alveolar clefts, with the iliac crest , bone being the most widely accepted donor site(Tan, Brogan et al. 1996.New bone graft substitutes have been devised in recent decades, such as demineralized bone matrix (DBM), bone morphogenetic proteins (BMPs), calcium phosphate (CP), calcium sulfate (CS), hydroxyapatite (HA), highly purified bovine xenograft, and more, but clinical evidence of their efficacy varies among clinical and experimental studies [4] With the advent of new biomaterials, which may include or consist of allogenic bone source such as collagen membranes, hydroxyapatite crystals, tricalcium phosphate powder that has been increased consideration for their placement in the repair of alveolar clefts as well as other dental applications

Enrollment: 20 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 disease 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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20 participants in 2 patient groups

autogenous iliac bone graft (group A)

Other group

Description:

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

Treatment:

Procedure: harvesting of the autogenous bone graft

Procedure: secondary alveolar bone graft

Nano crystalline Hydroxyapatite (group B)

Other group

Description:

Nano crystalline Hydroxyapatite will be used to fill the alveolar defect

Treatment:

Procedure: Nanocrystalline Hydroxyapatite

Procedure: secondary alveolar bone graft