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

Alveolar Cleft Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04693559
• Other study ID #: AssiutU011270
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2021
• Est. completion date: March 2023

Study information

• Verified date: December 2020
• Source: Assiut University
• Contact: Abdullah Hashim, MBBS
• Phone: +201148239460
• Email: abdulah011270[@]med.aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 2023
• Est. primary completion date: November 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Alveolar Cleft

Intervention

Procedure:
• secondary alveolar bone graft
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 graft
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
Nanocrystalline Hydroxyapatite will be used to fill the alveolar defect

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (7)

Boyne PJ, Sands NR. Secondary bone grafting of residual alveolar and palatal clefts. J Oral Surg. 1972 Feb;30(2):87-92. — View Citation

Cypher TJ, Grossman JP. Biological principles of bone graft healing. J Foot Ankle Surg. 1996 Sep-Oct;35(5):413-7. — View Citation

Feinberg SE, Weisbrode SE, Heintschel G. Radiographic and histological analysis of tooth eruption through calcium phosphate ceramics in the cat. Arch Oral Biol. 1989;34(12):975-84. — View Citation

Fernyhough JC, Schimandle JJ, Weigel MC, Edwards CC, Levine AM. Chronic donor site pain complicating bone graft harvesting from the posterior iliac crest for spinal fusion. Spine (Phila Pa 1976). 1992 Dec;17(12):1474-80. — View Citation

Kyung H, Kang N. Management of Alveolar Cleft. Arch Craniofac Surg. 2015 Aug;16(2):49-52. doi: 10.7181/acfs.2015.16.2.49. Epub 2015 Aug 11. Review. — View Citation

Mankin HJ, Gebhardt MC, Jennings LC, Springfield DS, Tomford WW. Long-term results of allograft replacement in the management of bone tumors. Clin Orthop Relat Res. 1996 Mar;(324):86-97. — View Citation

Porter AE, Patel N, Skepper JN, Best SM, Bonfield W. Effect of sintered silicate-substituted hydroxyapatite on remodelling processes at the bone-implant interface. Biomaterials. 2004 Jul;25(16):3303-14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months