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

NCT04693559 | Unknown

• 1 other identifier: AssiutU011270
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Alveolar Cleft

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

autogenous iliac bone graft (group A)

OTHER

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

Procedure: secondary alveolar bone graft; Procedure: harvesting of the autogenous bone graft

Nano crystalline Hydroxyapatite (group B)

OTHER

Nano crystalline Hydroxyapatite will be used to fill the alveolar defect

Procedure: secondary alveolar bone graft; Procedure: Nanocrystalline Hydroxyapatite

Interventions

secondary alveolar bone graft PROCEDURE

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

Nano crystalline Hydroxyapatite (group B); autogenous iliac bone graft (group A)

harvesting of the autogenous bone graft PROCEDURE

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

autogenous iliac bone graft (group A)

Nanocrystalline Hydroxyapatite PROCEDURE

Nanocrystalline Hydroxyapatite will be used to fill the alveolar defect

Nano crystalline Hydroxyapatite (group B)

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age (7 - 12 years )
• Non-syndromic CLA or CLP
• More than 6 months of follow-up

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• Boyne PJ, Sands NR. Secondary bone grafting of residual alveolar and palatal clefts. J Oral Surg. 1972 Feb;30(2):87-92. No abstract available.

  PMID: 4550446 BACKGROUND

• 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.

  PMID: 28913221 BACKGROUND

• Cypher TJ, Grossman JP. Biological principles of bone graft healing. J Foot Ankle Surg. 1996 Sep-Oct;35(5):413-7. doi: 10.1016/s1067-2516(96)80061-5.

  PMID: 8915864 BACKGROUND

• 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. doi: 10.1016/0003-9969(89)90055-1.

  PMID: 2558643 BACKGROUND

• 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. doi: 10.1097/00007632-199212000-00006.

  PMID: 1471005 BACKGROUND

• 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. doi: 10.1016/j.biomaterials.2003.10.006.

  PMID: 14980425 BACKGROUND

• 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. doi: 10.1097/00003086-199603000-00011.

  PMID: 8595781 BACKGROUND

MeSH Terms

Interventions

poly(2-hydroxyethyl methacrylate)-nanocrystalline hydroxyapatite

Central Study Contacts

Abdullah Hashim, MBBS

CONTACT

+201148239460; abdulah011270@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MBBS

Model Details: Patient will be randomized into to groups according to the surgical procedures performed as follow

Study Record Dates

• First Submitted: December 31, 2020
• First Posted: January 5, 2021
• Study Start: January 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: March 1, 2023
• Last Updated: January 5, 2021

Record last verified: 2020-12