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

Not Applicable

• Conditions: Alveolar Cleft
• Interventions: Procedure: secondary alveolar bone graft; Procedure: Nanocrystalline Hydroxyapatite; Procedure: harvesting of the autogenous bone graft

• Registration Number: NCT04693559
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed 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

Study Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-31
• Study First Submitted QC: 2020-12-31
• Last Update Submitted: 2020-12-31
• Study Start: 2021-01
• 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: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nano crystalline Hydroxyapatite (group B)	Nanocrystalline Hydroxyapatite	Nano crystalline Hydroxyapatite will be used to fill the alveolar defect
autogenous iliac bone graft (group A)	harvesting of the autogenous bone graft	autogenous iliac bone graft will be used to fill the alveolar defect
autogenous iliac bone graft (group A)	secondary alveolar bone graft	autogenous iliac bone graft will be used to fill the alveolar defect
Nano crystalline Hydroxyapatite (group B)	secondary alveolar bone graft	Nano crystalline Hydroxyapatite 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 nanocrystalline hydroxyapatite versus autogenous bone graft in alveolar bone grafting regarding the newly formed bone volume