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

Assiut University20 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Alveolar Cleft

Interventions

secondary alveolar bone graftPROCEDURE

Under general anaesthesia, the soft tissue in the gingiva surrounding the alveolar cleft will injected with 0.5% lidocaine with 1:100,000 parts of epinephrine. At the alveolar cleft site, gingival sulcus incisions will made on both the sides of the cleft. The tissue will then elevated beneath the periosteum. The mucosa of the nasal floor and the oral mucosa will dissected. Next, the bone particles will implanted into the bone defect. The cleft site will closed without tension by advancement of the gingival flaps

harvesting of the autogenous bone graftPROCEDURE

osteotome and then cut into small bone granules. The bone granules will then carefully placed into a syringe and pressed to its densest state by pushing the plunger

Nanocrystalline Hydroxyapatite

Eligibility

Sex: ALLMin age: 7 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Measuring of bone volume 6 months post-operative

compare between outcome of nanocrystalline hydroxyapatite versus autogenous bone graft in alveolar bone grafting regarding the newly formed bone volume

Time frame: 6 months

Central Contacts

Abdullah Hashim, MBBS

CONTACT

+201148239460 abdulah011270@med.aun.edu.eg

Data from ClinicalTrials.gov

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